Women in Validation: In Case You Missed It

One of my annual “must attend” events is the Institute of Validation Technology (IVT) Computer Systems Validation Annual Validation Week in October.  This is an excellent event to get the latest and greatest thinking on validation topics and industry guidance.  An official from the U.S. FDA attended the event and providing key information on the latest data integrity guidance and reorganization at the FDA.

The highlight of the event for me was a new session added called the “Women in Validation Empowerment Summit”.  The panel featured yours truly and along with other talented women in validation.  The goal of the panel was to discuss some of the unique challenges women face in STEM professions and how to over come them.  The panel was moderated by Roberta Goode of Goode Compliance International.  She led panelists through a lively discussion of topics ranging from career building, job challenges, work place difficulties and much more.  You can see a synopsis of what we discussed here.

I am a fierce advocate of STEM. There are women who are “hidden figures” in STEM professions such as computer systems validation that don’t get the recognition they so richly deserve or the attention of most corporate executives.  This session was about EMPOWERMENT.

There are many “hidden figures” in the field of validation but no real community surrounding them.  I left the session most impressed with my accomplished co-panelists.  Each and every one of them had tremendous insights on their career paths and stories to tell as to how they moved up the ladder.  The talk was real.  It was down to earth.  It was practical.  I didn’t want it to end!

A couple of troubling statistics highlighted during the session related to the number of undergraduate degrees earned by women in STEM.  According to The World Economic Forum, women earn “only 35 percent of the undergraduate degrees in STEM”.  The sad truth is this number remains unchanged for over a decade.  Look at the statistics for women in engineering from the National Science Foundation.

Women in Engineering I graduated in Civil and Environmental Engineering from the University of Wisconsin – Madison in 1982.  I was one of only 3 women in my class at the time.  You can see from the graph above that at the doctorate level, women drop off precipitously.

At the session, we discussed gender bias, stereotypes and other factors that affect women in our profession.  It was an excellent forum and one I hope they continue.  In case you missed it, the session was enlightening and fun for all!   See you in October!

Saving Time and Money Through Lean Validation

The principles and best practices of lean manufacturing have served life sciences manufacturers well.  Lean is all about optimizing processes, while eliminating waste (“Muda”) and driving greater efficiencies.  As a 30-year validation practitioner, I have validated many computer systems, equipment and processes.  One of the key lessons learned is that there is much room for improvement across the validation process.

OnShore Technology Group is a pioneer in lean validation and has developed principles and best practices to support lean validation processes.  To power our lean processes, we leverage ValidationMaster™, an Enterprise Validation Management system exclusively designed to facilitate lean validation and automate the validation process.

So what is lean validation and how is it practically used?

Lean validation is the process of eliminating waste and inefficiencies while driving greater software quality across the validation process through automation.

Lean Validation

Lean validation cannot be achieved without automation. Lean validation processes leverage advanced technology designed to fulfill the technical, business and compliance requirements for software validation eliminating the use of manual, paper-based processes. Optimized validation processes are deployed using the latest global best practices to ensure the right amount of validation rigor based on critical quality attributes, risks, Cybersecurity and other factors.

Lean validation process begins with a lean validation project charter which defines the description of the process and key performance indicators.  KPI’s such as reduce validation costs by $X/year or reduce software errors by X%.  The charter shall define the project scope, dependencies, project metrics and resources for the project.

There are five principles of lean validation  derived from lean manufacturing principles.  Lean validation is powered through people, processes and technology.  Automation drives lean validation processes.  The LEAN VALIDATION value principles are illustated in the figure below.

Lean-Validation-Graphic-600

Principle 1 – VALUE – Lean thinking in manufacturing begins with a detailed understanding of what value the customer assigns to product and services.  Lean thinking from an independent validation and verification perspective begins with a detailed understanding of the goals and objectives of the validation process and its adherence to compliance objectives.  The principle of VALUE requires the validation team to therefore focus on the elimination of waste to deliver the value the end customer (your organization) in the most cost-effective manner.  The computer systems validation process is designed for the purpose of assuring that software applications meet their intended use.  The value derived from the validation process is greater software quality, enhanced ability to identify software defects as a result of greater focus and elimination of inefficient and wasteful processes. AUTOMATION IS THE FOUNDATION THAT FACILITATES THE ACHIEVEMENT OF THIS VALUE PRINCIPLE.

Principle 2 – VALUE STREAM – The value stream, from a lean perspective is the comprehensive product life-cycle from the raw materials through customer’s end use, and ultimate disposal the product.  To effectively eliminate waste, the ultimate goal of lean validation, there must be an accurate and complete understanding of the value stream.  Validation processes must be examined end-to-end to determine what value is added to the objective of establishing software quality and compliance.  Any process that does not add value to the validation process should be eliminated.  We recommend value stream mapping for the validation process to understand where value is added and where non-value added processes can be eliminated.  Typical “Muda” or wastes commonly revealed from validation process mapping are:

  • Wasteful Legacy Processes (“we have always done it this way”)
  • Processes That Provide No Value To Software Quality At All
  • Manual Process Bottlenecks That Stifle Processes

Principle 3 – FLOW – The lean manufacturing principle of flow is about creating a value chain with no interruption in the production process and a state where each activity is fully in step with every other.  A comprehensive assessment and understanding of flow throughout the validation process is essential to the elimination of waste.  From a validation perspective, optimal flow is created through the process when, for example, users have the ability to automatically create requirements from test scripts for automated traceability thereby eliminating the process of manually tracing each test script to a requirement.  Another example is when a user has the ability to navigate through a software application and the test script process is automatically generated.  Once generated, it is automatically published to a document portal where it is routed electronically for review and approval.  All of this requires AUTOMATION to achieve the principle of FLOW.  For process optimization and quality control throughout the validation lifecycle, information should optimally flow throughout the validation process in an efficient manner minimizing process and document bottlenecks with traceability throughout the process.

Principle 4 – PULL – A pull system is a lean manufacturing is used to reduce waste in the production process. Components used in the manufacturing process are only replaced once they have been consumed so companies only make enough products to meet customer demand.  There is much waste in the validation process.  The PULL strategy for validation may be used to reduce wastes such as duplication of effort, streamlining test case development and execution, electronic signature routing/approval and many others.  Check out our blog “The Validation Post” for more information.

Principle 5 – PERFECTION – Validation processes are in constant pursuit of continuous improvement.  Automation is KEY.  Lean validation engineers and quality professional relentlessly drive for perfection. Step by step validation engineers must identify root causes of software issues, anomalies, and quality problems that affect the suitability of a system for production use. As computing systems environments evolve and become more complex and integrated, validation engineers must seek new, innovative ways to verify software quality and compliance in today’s advanced systems. Perfection cannot easily be achieved through manual processes.

AUTOMATION IS REQUIRED TO TRULY REALIZE THE VISION OF THIS PRINCIPLE.

You can save time and money through lean.  Consider the first 2 principles of Value and Value Stream.  Many validation engineers consider validation only as a regulatory requirement or “necessary evil” – rather than a regulatory best practice designed to save time and money.  I think we all agree that in the long run quality software saves time and money through regulatory cost avoidance and more efficiency throughout quality processes.

It is important for validation engineers to not only consider quality and compliance but cost savings that may be gained throughout the validation process.  Lean validation is a strategy whose time has come.  How much will cost savings be through lean?  End users report saving about 40 – 60% for test script development and 60 – 70% on regression testing efforts.  Regulatory cost avoidance can be significant depending on the level of compliance with each company.  Cost savings may also be realized in minimizing the amount of paper generated through the validation process.

Embrace LEAN VALIDATION and experience the benefits of saving time and money.

 

 

 

Why Are You Still Generating Validation Test Scripts Manually?

Drafting validation scripts is one of the key activities in a validation exercise designed to provide document evidence that a system performs according to its intended use.  The FDA and other global agencies require objective evidence, usually in the form of screen shots that sequentially capture the target software process, to provide assurance that systems can consistently and repeatedly perform the various processes representing the intended use of the system.

Since the advent of the PC, validation engineers have been writing validation test scripts manually.  The manual process of computer systems validation test script development involves capturing screenshots and pasting them into Microsoft Word test script templates.  To generate screen captures, some companies use tools such as Microsoft Print Screen, TechSmith SnagIT, and other such tools.  A chief complaint of many validation engineers is that the test script development process is a slow, arduous one.  Some validation engineers are very reluctant to update/re-validate systems due to this manual process.  So, the question posed by this blog article is simply this: “Why are you still generating test scripts manually???”

I have been conducting validation exercises for engineering and life sciences systems since the early 1980’s.  I too have experienced first-hand the pain of writing test scripts manually.  We developed and practice “lean validation” so I sought ways to eliminate manual, wasteful validation processes.  One of the most wasteful processes in validation is the manual capture/cutting/pasting of screenshots into a Microsoft Word document.

The obvious follow up question is “how do we capture validation tests in a more automated manner to eliminate waste and create test scripts that are complete, accurate and provide the level of due diligence required for validation?”

In response to this common problem, we developed an Enterprise Validation Management system called ValidationMaster™.  This system includes TestMaster™, an automated testing system that allows validation engineers to capture and execute validation test scripts in a cost-effective manner.

TestMaster™ is designed to validate ANY enterprise or desktop application.  It is a browser-based system and allows test engineers to open any application on their desktop, launch TestMaster™, and capture their test scripts while sequentially executing the various commands in their applications.    As the validation engineer navigates through the application, TestMaster™ captures each screenshot and text entry entered in the application.

Once the test script is saved, TestMaster™ allows the script to be published in your UNIQUE test script template with the push of a button.  No more cutting/pasting screenshots from manual processes!  You can generate your test scripts in MINUTES as opposed to the hours it sometimes takes to compile documents based on a series of screenshots.  If you are one of those validation engineers that does not like screenshots in your scripts, you can easily create text-based processes both quickly and easily using TestMaster™.

So, what is the biggest benefit of using TestMaster™ versus manual processes?  There are three key benefits which are summarized as follows:

  1.  Automated Test Script Execution– for years, validation engineers have wanted a more automated approach for the execution of validation test scripts.  ValidationMaster™ supports both hands-on or hands-off validation testing.  Hands-on validation testing is the process whereby a validation engineer looks at each step of a validation test script and executes the script step-by-step by clicking through the process.  Hands off validation allows a validation engineer to execute a test script with no human intervention.  This type of regression testing (hands off) is very useful for cloud-based systems or systems that require more frequent testing.  The validation engineer simply selects a test script and defines a date/time for its execution.  At the designated time with no human intervention, the system executes the test script and reports the test results back to the system.   Automated testing is here!  Why are you still doing this manually?

  1.  Traceability– TestMaster™ allows validation engineers to link each test script to a requirement or set of requirements, thus the system delivers automatic traceability which is a regulatory requirement.  With the click of a button, TestMaster™ allows validation engineers to create a test script directly from a requirement.  This is powerful capability that allows you to see requirements coverage through our validation dashboard on demand.  This validation dashboard is viewable on a desktop or mobile device (Windows, Apple, Android).

  1.  Test Script Execution– One of the biggest problems with manual test scripts is that they must be printed and manually routed for review and approval.  Some companies who have implemented document management systems may have the ability to route the scripts around electronically for review and approval.  The worst-case scenario is the company that has no electronic document management system and generates these documents manually.  TestMaster™ allows validation engineers to execute test scripts online and capture test script results in an easy manner.  The test script results can be captured in an automated way and published into executed test script templates quickly and easily.   If incidents (bugs/anomalies) occur during testing, users have the ability to automatically capture an incident report which is tied to the exact step where the anomaly/bug occurred.  Once completed, ValidationMaster™ is tightly integrated with a 21 CFR Part 11-compliant portal (ValidationMaster Portal™). Once the test script is executed, is it automatically published to the ValidationMaster™ Portal where it is routed for review/approval in the system.  The ability to draft, route, review, approve, execute and post-approve validation test scripts is an important, time/cost saving feature that should be a part of any 21stcentury validation program.

  1.  Reuse Test Scripts For Regression Testing– manual test scripts are not ‘readily’ reusable.  What I mean by this is that the Word documents must be edited or even re-written for validation regression testing.  Validation is not a one-time process.  Regression testing is a fact of life for validation engineers.  The question is, will you rewrite all of your test scripts or use automated tools to streamline the process.  ValidationMaster™ allows validation engineers to create a reusable test script library.  This library includes all the test scripts that make up your validation test script package.  During re-validation exercises, you have the ability to reuse the same test scripts for regression testing.

Given the rapid adoption of cloud, mobile and enterprise technologies in life sciences, a new approach to validation is required.  Yes, you can still conduct validation exercises on paper but why would you?  In the early days of enterprise technology, we did not have tools available that would facilitate the rapid development of validation test scripts.  Today, that is not the case.  Systems like ValidationMaster™ are available in either a hosted or on-premise environment.  These game-changing systems are revolutionizing the way validation is conducted and offering time/cost-saving features that make this process easier.   So why are you still generating test scripts manually?

Can Cloud Applications Be Validated?

Cloud applications are being deployed within life sciences Enterprises at a rapid pace. Microsoft office 365, Microsoft dynamics 365 and the cost benefit of deployment of other such applications are driving the adoption of cloud applications for regulated systems. The question that is always asked is can cloud systems be validated? The reason for the inquiry is due to the fact that many understand how clouds are deployed and maintained over time. In an effort to keep pace with system performance, security and other related controls in the cloud, cloud providers often update their environments to keep pace. The constant updating of the cloud environment makes it challenging from a systems validation perspective.  Maintaining the validated state in a cloud environment is often challenging due to this fact.

So can cloud applications be validated and what are the unique processes that must be changed to accommodate cloud validation?  The short answer is yes, cloud applications can be validated. However, there are changes required to the validation strategy to ensure that the system meets its intended use and the validated state is maintained over time.

ALL CLOUD PROVIDERS ARE NOT CREATED EQUAL

When choosing a cloud provider, it is helpful to understand that all cloud providers are not created equal. To my mind they are divided into two distinct camps: (1) those who understand regulated environments and (2) those who do not understand regulated environments. The first order of business for establishing a validated system in the cloud is to select your cloud providers carefully. I usually like to look at cloud providers who have experience in regulated environments. This goes for any application that you’re using in a highly regulated environment. It is super important that your vendor understand the regulatory requirements that you have to comply with and that in their service they build in best practices to help you comply. This will go a long way during the supplier audit process to confirm that you’ve done your proper due diligence on your cloud provider.

UNDERSTANDING RESPONSIBILITIES IN A CLOUD ENVIRONMENT

It is important to understand responsibilities in a cloud environment.  With packaged software applications, you have complete control over the environment.  With the various cloud service models, responsibilities vary depending on the model used as shown below.  For Infrastructure-as-a-Service, you manage the applications, data, runtime, middle ware and operating system.  While the vendor manages virtualization, servers, storage, and networking.  Please keep in mind that the principles of validation endure in the cloud.  You, not the vendor, are ultimately responsible for the environment and its management.  Therefore, you need to choose your cloud vendor wisely.

cloud services

You can see with Platform-as-a-Service (PaaS) and Software-as-a-Service (SaaS), you have less responsibility for the management of the system.  In the SaaS model, you do not control the application or infrastructure.  The vendor manages the application and it underlying architecture.

The strategy for validation changes based on the cloud model deployed.

The strategy for validation changes based on the cloud model deployed.

CONTINUOUS TESTING IN THE CLOUD

Previously four on premise systems, the validation engineer in consultation with the IT team determined how often validated systems environments were reviewed and updated. If the validation engineer did not want to apply a patch or an update, they simply left the system alone. Many validation engineers due to the labor involved in updating and documenting a validated system would often leave the system in a state where no changes, patches, or updates were applied. In today’s systems due to the threats from cyber security and frequent changes to browser applications, it is not possible to leave a system unpatched. To do so may leave your validated systems environment more exposed to security threats.

Therefore, when validating in the cloud you must employ a continuous testing strategy. When I say that to validation engineers they often cringe thinking of continuously having the test a validated systems environment. This is easier than you may think if you’re using automated tools for testing. Continuous testing is simply a validation testing strategy where on a designated schedule defined by the validation engineer, a system is routinely tested to ensure that patches, and routine updates do not impact the validated state. Continuous testing is facilitated best through automation. When developing a reusable test script Library, you can easily conduct an impact analysis and determine which tests need to be rerun. Regression testing is made easy through validation test script automation. Therefore, it is strongly recommended that if you deploy systems in a cloud environment that you employ an enterprise validation management system that includes automated testing such as ValidationMaster™.

Cloud applications can be validated.  The strategy changes based on the cloud model selected.  Choose your partners carefully.  They assume an important role in the management of critical system assets.

It is not a question of if a cloud application can be validated, it is a question of the deployment model you choose and the validation strategy that will govern deployment. Regulators are not averse to you using the cloud – its all about managing control and risk.

 

Accelerating Validation in the 21st Century

Each day in companies across the globe, employees are being asked to do more with less.  The mantra of the business community in the 21st century is “accelerating business”.  You see it in marketing and all types of corporate communication.  In the validation world accelerating system implementation, validation and deployment is the cry of every chief information officer and senior executive.

Accelerating validation activity means different things to different people.  I define it as driving validation processes efficiently and effectively without sacrificing quality or compliance.  Most manual processes are paper-based, inefficient, and cumbersome.  Creating paper-based test scripts requires a lot of cutting/pasting of screenshots and other objective evidence to meet regulatory demands.  Getting validation information into templates with proper headers and footers in compliance with corporate documentation guidelines is paramount.

The question for today is “HOW DO WE ACCELERATE VALIDATION WITHOUT SACRIFICING QUALITY AND COMPLIANCE?”

Earlier in my career, I developed “Validation Toolkit” for Documentum and Qumas.  A Validation Toolkit was an early version of a validation accelerator.  Many companies now have them.  These toolkits come with pre-defined document templates and test scripts designed to streamline the validation process.  They are called “tookits” for a reason – they are not intended to be completed validation projects.  They are intended to be a starting point for validation exercises.

The FDA states in the General Principles of Software Validation; Final Guidance For Industry and FDA Staff issued on January 11, 2002, “…If the vendor can provide information about their system requirements, software requirements, validation process, and the results of their validation, the medical device manufacturer (or any company) can use that information as a beginning point for their required validation documentation…”

Notice, that the FDA says “… use a beginning point” for validation – NOT USE IT EXCLUSIVELY AS THE COMPLETE VALIDATION PACKAGE.  This is because the FDA expects each company to conduct its own due diligence for validation.  Also note that the FDA allows the use of such documentation if available from a vendor.

Beware that some vendors believe their “toolkits” can substitute for rigorous review of their software applications.  It cannot.  In addition to leveraging the software vendor information, you should ALWAYS conduct your own validation due diligence to ensure that applications are thoroughly examined without bias by your team or designated validation professional.

It is an excellent idea to leverage vendor information if provided.  There is a learning curve with most enterprise applications and the use of vendor-supplied information can help streamline the process and add value.  The old validation toolkits were delivered with a set of document templates and pre-defined test scripts often resulting in hundreds of documents depending on the application.  In most cases, companies would edit the documents or put them in their pre-defined validation templates for consistency.  This resulted in A LOT OF EDITING!  In some cases, depending on the number of documents, time-savings could be eroded by just editing the existing documents.

THERE IS A BETTER WAY!  

What if YOUR unique validation templates were pre-loaded into an automated Enterprise Validation Lifecycle Management system?   What if the Commercial-off-the-Shelf (COTS) product requirements were pre-loaded into this system?  Further, what if a full set of OQ/PQ test scripts were traced to each of the pre-loaded requirements?  What if you were able to export all of these documents day one in your unique validation templates?  What if you only had to add test scripts that represented the CHANGES you were making to a COTS application versus writing all of your test scripts from scratch?  Finally, what if you could execute your test scripts on line and automatically generate a requirements trace matrix and validation summary report with PASS/FAIL status?

This is the vision of the CloudMaster 365™  Validation Accelerator.  CloudMaster 365™  is the next generation of the validation toolkit concept.    The ValidationMaster Enterprise Validation Management system is the core of the CloudMaster 365™ Validation Accelerator.  The application can be either hosted or on-premise.  This is a great way to jump start your Microsoft Dynamics 365® validation project.

CloudMaster 365

The CloudMaster 365™ Validation Accelerator includes (3) key components:

  • ValidationMaster™ Enterprise Validation Management System
  • Comprehensive set of user requirements for out-of-the-box features
  • Full set of IQ/OQ/PQ test scripts and validation document templates

The Validation Accelerator is not intended to be “validation out of the box”.  It delivers the foundation for your current and future validation projects delivering “Level 5” validation processes.  If you consider the validation capability maturity model, most validation processes at level 1 are ad hoc, chaotic, undefined and reactive to project impulses and external events.

Validation Maturity Model

Level 5 validation is an optimized, lean validation process facilitated with automation.  The test process is optimized, quality control is assured and there is a specific measure for defect prevention and management.  Level 5 cannot be achieved without automation.  The automation is powered by ValidationMaster™.   With the CloudMaster 365™ strategy, instead of having “toolkit” documents suitable for only one project, you have a system that manages your COTS or bespoke development over time and manages the full lifecycle of validation over time as is required by regulators.  This is revolutionary in terms of what you get.

CloudMaster 365™ TRULY ACCELERATES VALIDATION.  It can not only be used for Microsoft Dynamics 365®, but is also available for other applications including:

  • CloudMaster 365™ Validation Accelerator For Dynamics 365®
  • CloudMaster 365™ Validation Accelerator For Merit MAXLife®
  • CloudMaster 365™ Validation Accelerator For Yaveon ProBatch®
  • CloudMaster 365™ Validation Accelerator For Oracle e-Business® or Oracle Fusion®
  • CloudMaster 365™ Validation Accelerator For SAP®
  • CloudMaster 365™ Validation Accelerator For BatchMaster®
  • CloudMaster 365™ Validation Accelerator For Edgewater EDGE®
  • CloudMaster 365™ Validation Accelerator For VeevaVault®
  • CloudMaster 365™ Validation Accelerator For Microsoft SharePoint®

Whether you are validating an enterprise application or seeking to drive your company to higher levels of efficiency, you should consider how best to accelerate your validation processes not solution by solution but in a more holistic way that ensures sustained compliance across all applications.  If you are embarking on the validation of Microsoft Dynamics 365®, or any of the applications listed above, the CloudMaster 365™ Validation Accelerator is a no-brainer.  It is the most cost-effective way to streamline validation and ensure sustained compliance over time.

5 Ways to Revive Your CSV Validation Process in 2018

If you are like most veteran validation engineers, you have been conducting validation exercises the same old way.  You have been gathering user requirements, conducting risk assessments, developing test scripts (most often on paper) and delivering validation documentation and due diligence as required by current global regulations.

Validation processes have not changed very much over the last 40 years (unless you include ISPE GAMP® as revolutionary).  However, the systems we validate and the state of play with respect to cybersecurity, data integrity, mobility and compliance has changed in a profound way.  Cloud-based applications are seeing increasing adoptions.  Platforms such as Microsoft Azure are changing the way companies do business.  Mobility is in the hands of everyone who can obtain an affordable device.  These game-changing trends call for changes in the way we wake up our sleepy validation processes and use them as opportunities for process improvement.

To help you address these new challenges for the coming year, I offer 5 ways to revive sleepy, manual validation processes for your consideration.

  1. Think LEAN
  2. Automate
  3. Leverage Electronic Document Review & Approval Processes
  4. Adopt Agile Validation Processes
  5. Conduct Cybersecurity Qualification

STEP 1.  THINK LEAN

Lean manufacturing is a proven process that powered Toyota to success. Lean manufacturing processes were designed to eliminate waste and improve operational efficiency. Toyota adopted lean manufacturing processes and rose to prominence with quality vehicles that outsold most of their competitors in each automotive class. To improve your validation processes in today’s systems environment, it is important to think lean. As we are being asked to do more with less as validation engineers it is important and dare I say critical that you eliminate any wasteful processes and focus on validation processes that in the end at value. This is the basic premise of lean validation.

Throughout my practice, we deliver lean validation services to all of our clients. Lean validation is powered through automation. You can’t have a lean validation process without automation since automation powers lean. Through automation and lean validation processes, we are able to automate the development and management of requirements, incidents, and validation testing in a manner not possible on paper. As you look to wake up your validation processes in 2018, it is important to think lean. I wrote a blog article on the principles and best practices of lean as a good starting point to educate you as to how to maintain and establish lean validation processes.

STEP 2.  AUTOMATE

As I mentioned above you cannot adopt lean validation processes unless you automate your validation processes. Automation has often been looked at by validation engineers as a luxury rather than the necessity. In 2018, automation of the validation process is a necessity not a luxury. Electronic workflow used to be the purview of expensive enterprise systems often costing in the millions of dollars. Today, there is no excuse for not automating your process other than simply not wanting to change.

Electronic systems to manage automated validation processes have come a long way in the last 20 years. We offer a system call ValidationMaster™  which was designed by validation engineers for validation engineers. ValidationMaster™  is an enterprise validation management system designed to manage the full lifecycle of validation processes. From requirements to test script development and execution through incident reporting and validation document control, validation master manages the full lifecycle of validation processes and their associated deliverables. The system comes with a fully integrated validation master portal based on SharePoint designed to manage document deliverables in a controlled manner. The system is integrated with electronic signatures and graphical workflows to eliminate document bottlenecks and improve the process of development of your document deliverables.

The development and execution of test cases represents the most laborious part of validation. This is where most validation exercises are either successful or fail. Most often, given the manual cryptic nature that most validation engineers use to develop test scripts, a lot of focus is spent on the actual development of the test script and not the quality of the test case itself. This is due to wasteful processes such as cutting and pasting screenshots or manually typing in information that the validation engineer sees on the screen during the manual test script development process. Both the process of capturing screenshots or typing in information to describe a screen are considered in my view wasteful and don’t add to the value of the test case.

The FDA says a good test case is one that finds an error. As validation engineers we should be focused more on finding errors and software quality than cutting and pasting screenshots into word documents as most of us do. There are things that computers can do much more efficiently and effectively than humans can do and one of them is automated test generation.

There are tools on the market such as ValidationMaster™ that allow you to fully automate this process and eliminate the waste in this process. ValidationMaster™ allows you to navigate through the application that is subject for your validation exercise while the system automatically captures the screenshot and the text and places this text directly into your formatted documents. You simply push a button at the end of the test script development and your test script is written for you. This is standard out-of-the-box functionality. Managing requirements for enterprise applications can also be laborious and challenging.

If you are validating enterprise resource planning systems which consist of hundreds of requirements, keeping track of the version of each requirement may be difficult. Who changes a requirement and why was a requirement changed is often the subject of hours and hours of meetings that waste time and money. ValidationMaster™ has a full-featured requirements management engine which not only tracks the requirement but it tracks the full audit history of a requirement so that you can understand who change the requirement, when was the requirement changed and why. This gives you full visibility to requirements. These requirements can be directly traced to test scripts thereby fully automating requirements traceability in your validation process.

Validation testing can be conducted online as either a fully automated validation test script which requires no human intervention or test cases that are semi-automatic where the validation engineer navigates through each software application and the actual results are captured by the system.

Manually tracking tests runs can be a headache and sometimes error-prone. An automated system can do this for you with ease. ValidationMaster™ allows you to conduct multiple tests runs and it tracks each of the tests runs, the person who ran the test, how long it took to actually execute the test, and the actual results of the test. If an incident or software anomaly occurred during testing the automated system would actually allow you to capture that information and keeps the incident report with each validation test. The time for automation has calm.

If you want to wake up your sleepy validation processes and deliver greater value for your company, you cannot afford to overlook automation of your validation process. Check out a demonstration of ValidationMaster™ to see how automated validation lifecycle management can work for you.

STEP 3 – LEVERAGE ELECTRONIC DOCUMENT REVIEW & APPROVAL PROCESSES

One of the many challenges that validation engineers experience every day is the route review and approval of validation documentation. In many paper-based systems this involves routing around printed documents for physical handwritten signatures. This is the way we did it in the 1980s. 21st-century validation requires a new more efficient approach. As mentioned in the section above on automation, there really is no excuse for using manual paper-based processes anymore. There are affordable technologies on the market that would facilitate electronic document review and approval processes and tremendously speed up the efficiency and quality of your document management processes.

In one previous company that I worked for our document cycle times were up to 120 days per document. With electronic route and review using 21 CFR part 11 electronic signatures we managed to get the process down to three weeks which saved a significant amount of time and money. Electronic document review and approval is a necessity and no longer a luxury there are tools on the market that costs less than a happy meal per month that would allow you to efficiently route and review your validation documentation and apply electronic signatures in compliance with 21 CFR part 11. To wake up your document management processes electronic document review and approval is a MUST.

STEP 4 – ADOPT AGILE VALIDATION PROCESSES

For as long as I can remember, whenever validation was spoken up we talked about the V model. This is the model as shown in the figure below where validation planning happens on the left-hand side of the V and validation testing happens on the right-hand side of the V.

V-MODEL

This model often assumed a waterfall approach to software development where all requirements were developed in advance and were tested subsequent to the development/configuration process. In today’s systems environment this is actually not how software is developed or implemented in most cases. Most development teams use an agile development process. Agile software development methodologies have really revolutionized the way organizations plan, develop, test and release software applications today. It is fair to say that agile development methods have now been established as the most accepted way to develop software applications. Having said this, many validation engineers insist on the waterfall methodology to support validation.

Agile development is basically a lightweight software development methodology that focuses on having small time boxed sprints of new functionality that are incorporated into an integrated product baseline. In other words, all requirements are not developed upfront. Agile recognizes that you may not know all requirements up front. The scrum places emphasis on customer interaction, feedback and adjustments rather than documentation and prediction. From a validation perspective this means iterations of validation testing as software iterations are developed in sprints. It’s a new way of looking at validation from the old waterfall approach. This may add more time to the validation process overall but the gradual introduction of functionality within complex software applications has value in and of itself. The Big Bang approach of delivering ERP systems sometimes has been fraught with issues and has sometimes been error-prone. The gradual introduction of features and functionality within software application has its merits. You should adopt agile validation processes to wake up your current processes.

STEP 5 – CONDUCT CYBERSECURITY QUALIFICATION (CYQ)

Last but not least is cyber security. In my previous blog posts, I discussed extensively the impact of cyber security on validation. I cannot emphasize enough how you need to pay attention to this phenomenon and be ready to address it. Cyber threats are a clear and present danger not only to validated systems environments but to all systems environments. As validation engineers our job is to ensure that system are established and meet their intended use. How can you confirm that the system meets its intended use when it’s vulnerable to cyber threats? The reality is you can’t.

Many validation engineers believe that cyber security is the purview of the IT department. This is something that the IT group is responsible for handling and many believe that it has nothing to do with validation. Nothing could be further from the truth. If you remember the old adage in validation “if it’s not documented it didn’t happen” you will quickly realize that you must document your readiness to deal with a cyber security event in the event that one occurs in your environment.

I call this “cyber security qualification” or “CyQ”. A cyber security qualification is an assessment of your readiness to protect validated systems environments against the threat of a cyber event. The CyQ is intended to evaluate your readiness to ensure compliance. One of the ways that you can wake up your validation processes in 2018 is to understand and educate yourself as to the threats that cyber events can have on your current validated systems environment and conduct a CyQ in addition to your IQ/OQ/PQ testing to ensure that you have the processes and procedures in place to deal with any threats that may come your way.  If you would like to see an example of a CyQ just write me and I’ll send you one.

2018 is going to bring many challenges your way. It is time that you bring your validation processes to level V validation maturity as shown in the figure below. You need to develop more mature processes that deal with the threats of cyber security and embrace lean validation and agile methodologies. If you’re like most you will be asked to do more with less. Updating old antiquated validation processes is essential to you being able to have the agility to do more with less.  It’s about time that you revive your old antiquated validation processes. Are you ready to go lean?

Cloud Validation Strategies

If you were to ask me 10 years ago how many of my life sciences clients were deploying systems in the cloud environment I would’ve said may be perhaps one or two. If you ask me today how many of my clients are deploying cloud’s technologies I would say most all of them in one way or another.  The adoption of cloud technologies within life sciences companies is expanding at a rapid pace.

From a validation perspective, this trend has profound consequences.  Here are some key concerns and questions to be answered for any cloud deployment.

  1. How do you validate systems in a cloud environment?
  2. What types of governance do you need to deploy applications in a cloud environment?
  3. How do you manage change in a cloud environment?
  4. How do you maintain the validated state in the cloud?
  5. How can you ensure data integrity in the cloud?
  6. How do you manage cybersecurity in a cloud environment?

The answers to these questions are obvious and routine to validation engineers managing systems in an on-premise environment where the control of the environment is managed by the internal IT team.  They have control over changes, patches, system updates, and other factors that may impact the overall validated state.  In a cloud environment, the software, platform and infrastructure is delivered as a SERVICE.  By leveraging the cloud, life sciences companies are effectively outsourcing the management and operation of a portion of their IT infrastructure to the cloud provider.  However, compliance oversight and responsibility for your validated system cannot be delegated to the cloud provider.  Therefore, these services must have a level of control sufficient to support a validated systems environment.

For years, life sciences companies have been accustomed to governing their own systems environments.  They control how often systems are updated, when patches are applied, when system resources will be updated, etc.  In a cloud environment, control is in the hands of the cloud service provider.  Therefore, who you choose as your cloud provider matters.

So what should your strategy be to manage cloud-based systems?

  • Choose Your Cloud Provider Wisely – All cloud providers are not created equally.  The Cloud Security Alliance (https://cloudsecurityalliance.org/ ) is an excellent starting point for understanding cloud controls.  The Cloud Controls Matrix (CCM) is an Excel spreadsheet that allows you to assess a vendors readiness for the cloud.  You can download it free of charge from the CSA.
  • Establish Governance For The Cloud – You must have an SOP for the management and deployment of the cloud and ensure that this process is closely followed.  You also need an SOP for cyber security to provide a process for protecting validated systems against cyber threats.
  • Leverage Cloud Supplier Audit Reports For Validation – All cloud providers must adhere to standards for their environments.  Typically, they gain 3rd party certification and submit to Service Organization Control (SOC) independent audits.  It is recommended that you capture the SOC 1/2/3 and SSAE 16 reports.  You also want to understand any certifications that your cloud provider has.  I would archive their certifications and SOC reports with the validation package as part of my due diligence for the supplier audit.
  • Embrace Lean Validation Principles and Best Practices – eliminating waste and improving efficiency is essential in any validated systems environment.  Lean validation is derived from the principles of lean manufacturing.  Automation is a MUST.  You need to embrace lean principles for greater efficiency and compliance.
  • Automate Your Validation Processes – Automation and Lean validation go hand in hand.  The testing process is the most laborious process.  We recommend using a system like ValidationMaster™ to automate requirements management, test management and execution, incident management, risk management, validation quality management, agile validation project management, and validation content management. ValidationMaster™ is designed to power lean validation processes and includes built-in best practices to support this process.
  • Use a Risk-Based Approach To Validation – all validation exercises are not created equal.  The level of validation due diligence required for your project should be based on risk – regulatory, technical and business risks.  Conduct a risk assessment for all cloud-based systems.
  • Adopt Continuous Testing Best Practices – the cloud is under continuous change which seems in and of itself counter-intuitive to the validation process.  Continuous testing can be onerous if your testing process is MANUAL.  However, if you adopt lean, automated testing processes regression testing is easy.  You can establish a routine schedule for testing and if your cloud provider delivers a dashboard that tells you when patches/updates/features have been applied and the nature of them, you can select your regression testing plan based on a risk and impact assessment.

 

Cloud environments can be validated!  A clear, practical approach that embraces lean validation and continuous testing is key.  Cloud governance to ensure data integrity and sustained compliance is key.

Cloud technologies are here to stay.  Regulators don’t object to the use of the cloud, they want to know how you are managing it and ensuring the integrity of the data.  They also want you to confirm that you are maintaining the validated state in the cloud.  The principles of validation endure in the cloud.  Just because you are in a cloud environment does not mean validation principles no longer apply.  Consider the impact of cybersecurity in your cloud environment and adopt continuous testing strategies to ensure sustained compliance.

Understanding Lean Validation: A Practical Approach

Lean manufacturing has been with us since 1988.   Lean principles were derived from the Japanese manufacturing industry.  The “Lean” process was originally created and adopted by Toyota designed to eliminate waste and inefficiency in its manufacturing operations.  Lean processes led to the Toyota Production System (TPS) which is arguably one of the greatest manufacturing success stories of all time.  The focus of lean was the elimination of waste and inefficiencies throughout the manufacturing process.

To identify and eliminate waste from the production process, Toyota believed it was important to understand exactly the nature of waste and where it existed. While Toyota’s products significantly differed between factories, the typical wastes found in manufacturing environments were similar in nature. For each waste, Toyota developed an effective strategy to reduce or eliminate its effects, thereby improving overall performance and quality.  The process became so successful that it has been embraced in manufacturing sectors around the world. Today’s manufacturers have embraced the concepts and philosophies of lean.  Being lean is considered critical competitive advantage and strategic imperative.  It has made Toyota an automotive success story.

I have been a validation practitioner for over 30 years.  In the process of validating large engineering systems and life sciences quality and compliance management technologies, I have experienced first hand the waste involved in the validation processes.  From manually cutting and pasting screenshots into test cases to manually tracing requirements to test scripts through manual document route/review processes and rewriting scripts for regression testing, waste abounds in the validation process.  As I pondered my work over the past three decades, I began to think of a better way to validate computer systems.

In my initial research, I started to think of all of the wastes throughout validation processes and categorized them.

validation waste

Wastes in the validation process include planning process wastes, testing wastes, documentation wastes, defect wastes, wasteful requirement processes, quality and incident management wastes and wastes associated with the re-validation and re-testing of software applications.  As I began to ponder solutions to eliminate these wastes throughout the validation process, I embarked on the development of a Lean Validation strategy.  We endeavor to save our clients both time and money throughout the validation process.  OnShore Technology Group is the only company whose practice focuses on the the delivery of Lean Validation services.  Our products and services are uniquely designed to power lean validation processes.

Lean Validation

Using lean validation principles can result in the elimination of wasteful manual validation processes and significant improvements in validation efficiency, document cycle times, increased testing productivity and greater ability to identify and correct software defects leading to enhanced software quality, lower costs and improved regulatory compliance.

OnShore Technology Group has pioneered the principles and best practices of “Lean Validation” – the process of eliminating waste and inefficiencies while driving greater software quality throughout the validation process.  In addition to the delivery of expert lean validation services, OnShore’s flagship software application is known as ValidationMaster™ – the FIRST Enterprise Validation Management and Quality system designed to automate lean validation processes.  ValidationMaster™ delivers a single source of truth for any type of validation including software, equipment, process, cold chain, facility, and other types of validation projects.

ValidationMaster™ is also the first validation management system accessible via any Window, Apple or Android mobile device.  The system includes key features such as a validation dashboard, fully automated test script development and execution, automatic requirements traceability, custom report development and generation and a full range of quality management capabilities (training, audit management, change management, controlled document management, ISO, validation KPI’s, CAPA, nonconformance management and much more.

In 2017, OnShore Technology Group was recognized as the “Best IV&V Automation Solutions Provider” and the “Software Validation Testing Experts of the Year”.  In 2016, OnShore made the coveted annual list of CIOReview Magazine as one of the 20 Most Promising Pharma & Life Sciences Tech Solution Providers”.

Contact us today to learn more and see a live demonstration of ValidationMaster™.

Computer Systems Validation As We Know It Is DEAD

Over the past 10 years, the software industry has experienced radical changes.  Enterprise applications deployed in the cloud, the Internet of Things (IoT), mobile applications, robotics, artificial intelligence, X-as-a-Service, agile development, cybersecurity challenges and other technology trends force us to rethink strategies for ensuring software quality.  For over 40 years, validation practices have not changed very much.  Suprisingly, many companies still conduct computer systems validation using paper-based processes.  However, the trends outlined above challenge some of the current assumptions about validation.  I sometimes hear people say “… since I am in the cloud, I don’t have to conduct an IQ…” or they will say, “… well my cloud provider is handling that…”

Issues related to responsibility and testing are changing based on deployment models and development lifecycles.  Validation is designed to confirm that a system meets its intended use.  However, how can we certify that a system meets its intended use if it is left vulnerable to cyber threats?  How can we maintain the validated state over time in production if the cloud environment is constantly changing the validated state?  How can we adequately test computer systems if users can download an “app” from the App Store to integrate with a validated system?  How can we ensure that we are following proper controls for 21 CFR Part 11 if our cloud vendor is not adhering to CSA cloud controls?  How can we test IoT devices connected to validated systems to ensure that they work safely and in accordance with regulatory standards?

You will not find the answers to any of these questions in any regulatory guidance documents.  Technology is moving at the speed of thought yet our validation processes are struggling to keep up.

These questions have led me to conclude that validation as we know it is DEAD.  The challenges imposed by the latest technological advances in agile software development, enterprise cloud applications, IoT, mobility, data integrity, privacy and cybersecurity are forcing validation engineers to rethink current processes.

Gartner group recently announced that firms using IoT grew from 29% in 2015 to 43 % in 2016.  They project that by the year 2020, over 26 billion devices will be IoT-devices.  it should be noted that Microsoft’s Azure platform includes a suite of applications for remote monitoring, predictive maintenance and connected factory monitoring for industrial devices.  Current guidance has not kept pace with ever-changing technology yet the need for quality in software applications remains a consistent imperative.

So how should validation engineers change processes to address these challenges?

First, consider how your systems are developed and deployed.  The V-model assumes a waterfall approach yet most software today is developed using Agile methodologies.  It is important to take this into consideration in your methodologies.

Secondly, I strongly recommend adding two SOPs to your quality procedures – a Cybersecurity SOP for validated computer systems and a Cloud SOP for validated systems.  You will need these two procedures to provide governance for your cloud processes.  (If you do not have a cloud or cybersecurity SOP please contact me and I will send you both SOPs.)

Third, I believe you should incorporate cybersecurity qualification (CyQ) into your testing strategy.  In addition to IQ/OQ/PQ, you should be conducting a CyQ readiness assessment for all validated systems.  A CyQ is an assessment to confirm and document your readiness to protect validated systems against a cyber attack.  It also includes testing to validate current protections for your validated systems.  It is important to note that regulators will judge you on your PROACTIVE approach to compliance.  This is an important step in that direction.

cyq-1

Forth, you should adopt lean validation methodologies.  Lean validation practices are designed to eliminate waste and inefficiency throughout the validation process while ensuring sustained compliance.

Finally, the time has come for automation.  To keep pace with the changes in current technology as discussed above, you MUST include automation for requirements management, validation testing, incident management and validation quality assurance (CAPA, NC, audit management, training, et al).  I recommend consideration of an Enterprise Validation Management system such as ValidationMaster™ to support the full lifecycle of computer systems validation.  ValidationMaster™  allows you to build a re-usable test script library and represents a “SINGLE SOURCE OF TRUTH” for all of your validation projects.  Automation of the validation process is no longer a luxury but a necessity.

Advanced technology is moving fast.  The time is now to rethink your validation strategies for the 21st century.  Validation as we know it is dead.  Lean, agile validation processes are demanded to keep pace with rapidly changing technology.  As you embrace the latest cloud, mobile and IoT technologies, you will quickly find that the old ways of validation are no longer sufficient.  Cyber criminals are not going away but you need to be ready. Step into LEAN and embrace the future!

 

What Is The ROI For Automated Validation Testing?

Independent Verification and Validation (IV&V) is a regulatory imperative for software deployments within the life sciences industry.  The FDA provides guidance on what is expected during the validation process and how to conduct due diligence for the validation process.

IEEE 1012 is the industry standard for IV&V.  This industry standard provides the background, rationale, process, list of deliverables and standards for the conduct of validation exercises.  A common question always comes up during my discussions with clients and prospects and that is the question of return on investment of the validation process.  As life sciences firms implement validation processes for their enterprise cloud and on-premise systems, increasingly many companies are turning to outsourcing of the IV&V process to save both time and money.

Validation is traditionally thought of as a regulatory imperative and is generally accounted for in capitalized expenses or direct expenses to the business.  However, as outsourcing becomes more prevalent and companies consider validation as more of a legal best practice, life sciences executives are rethinking IV&V strategies and seeking a cost-effective approach to ensuring compliance and software quality.

It is understood that releasing enterprise software with defects is risky business and costly.  For software applications driving highly regulated processes deficient software can have a direct impact on product quality or other critical quality attributes.  IV&V is designed to improve the quality and reliability of software systems and detect bugs/defects prior to production use.

IV&V activities should be conducted INDEPENDENTLY of the development team.  Many organizations often blur the lines between the two teams but they are distinct.  The figure below shows a typical development team and the correlation between IV&V activities.  The IV&V team receives information from the development team

ieee 12207 sw process with ivv1

The typical V-model for independent validation and verification is highlighted in the figure below.  Lean validation methods and agile processes are designed to streamline efforts, eliminate waste from the validation and improve efficiencies thereby improving ROI.

WHAT IS RETURN ON INVESTMENT (ROI) & WHY SHOULD YOU CARE?

 

ROI is a performance measure used to evaluate the efficiency of an investment or to compare the efficiency of a number of different investments. To calculate ROI, the benefit (return) of an investment is divided by the cost of the investment; the result is expressed as a percentage or a ratio.

A return on investment formula can be expressed as:

ROI = (Gain from Investment – Cost of Investment)/Cost of Investment

For most life sciences companies, validation is considered a regulatory imperative where the return on investment is not necessarily factored into the decision to validate.  However, validation can be thought of as a legal best practice which can offer return on investment and key benefits.  The key questions to consider are:

  1. What is the cost of the IV&V investment?
  2. What are the tangible and non-tangible benefits gained by life sciences companies?

IV&V along with the cost of quality associated with such projects can typically cost 5 to 10 percent of the total cost of an IT project, depending on the complexity of the project and the specific scope of QA/IV&V activities.

A defect that costs $1 to fix in the requirements or design phase costs $100 to fix  after the software goes into production (live) use.

Several studies indicate that the ROI on IV&V and software quality assurance investments can be 2 to 10 times the investment in QA/IV&V activities depending on how its measured.  There are several studies on the market that address the return on investment for validation as highlighted below.

ROI analysis is an important tool to understand the cost-effectiveness of your validation efforts.  This is why you should care.  Automation of the validation process can play an important role in maximizing your return on investment.  Join us for one of our weekly webinars and let us show you how.

WHAT SHOULD YOU PAY FOR IV&V?

IV&V delivers tremendous value for life sciences companies in early detection and elimination of software defects.  It is reasonable to expect IV&V cost to at least equal internal defect discovery costs or from 5- 10% of a typical project.  This depends on several factors including how customized the system is.  Bespoke development projects are must costlier than COTS systems that require little or no customization.

The simple cost Break Even Point is reached when:

  • IV&V cost = IV&V Savings
  • (1)(0.3)($x/SM)(Zsize)= (100)( Y)($x/SM)
  • (0.3) Zsize = 100 Y
  • (0.3)Zsize/100 = Y *SM – size metric could be expressed as Lines of Code, Function Points, …

One way to achieve greater ROI is through automation.  Automated validation testing can accelerate validation and improve ROI over time.  Automated testing systems like ValidationMaster™ allow you to create a reusable test script library to facilitate regression testing and improve initial testing.

CLOSING THOUGHTS

It should be understood that there is tremendous value inherent in the validation process.  There are several final points for your consideration:

  • No commercial or bespoke software is defect free
  • Early detection is designed to save both time and money
  • Reducing costs by minimizing validation may actually result in INCREASED COST during the operational phase of the system.
  • Validation testing should be automated to achieve maximum ROI