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.

 

 

 

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?

Risk Management & Computer Systems Validation: The Power Twins

For as long as systems have been validated, risk is an inherent part of the process.  Although validation engineers have been drafting risk assessments since the beginning of computer systems validation, many do not understand how crucial this process is to the overall validation process.

Risk management and validation go hand-in-hand.  The ISPE GAMP 5® (“GAMP 5”) methodology is a risk-based approach to validation.  GAMP 5 recommends that you scale all validation life cycle activities and associated documentation according to risk, complexity and novelty.  As shown in the figure below, the key drivers for GAMP 5 is science-based quality management of risks.

Drivers for GAMP 5

From a systems perspective, quality risk management, according to GAMP 5 is “…a systematic approach for the assessment, control, communication, and review of risks to patient safety, product quality, and data integrity.  It is an iterative process applied throughout the entire system life cycle…”  The guidance recommends qualitative and quantitative techniques to identify, document and manage risks over the lifecycle of a computer system.  Most importantly, they must be continually monitored to ensure the on-going effectiveness of each implemented control.

Risk assessments may be used to drive the validation testing process.  In our practice, we focus on critical quality attributes and four types of risks:

  • Business Risks
  • Regulatory Risks
  • Technical Risks
  • Cybersecurity Risks

The last type of risk, cybersecurity risks, is one that has not gotten a lot of attention from validation engineers and is not explicitly mentioned in GAMP 5.  However, this type of risk represents a clear and present danger to ALL systems, not just validated ones.  Cyber threats are real.  Large-scale cybersecurity attacks continue to proliferate across many enterprises and cyber criminals are broadening their approaches to strengthen their impact.  You need to look at a holistic approach to risk that not only includes the traditional risk assessment from GAMP as highlighted in the figure below but one that includes and incorporates cybersecurity as a real threat and risk to validated systems environments.

Risk Assessment - gamp 5

Cyber threats most certainly may impact product quality, patient safety and even data integrity.  We incorporate these risks into our risk management profile to provide a more comprehensive risk assessment for computer systems.

ZDNet reports that “…As new security risks continue to emerge, cloud security spending will grow to $3.5 billion by 2021…”

ZDNet June 15, 2017

As life sciences companies increase their adoption of the cloud, new challenges for validate systems environment are emerging and the risks that go along with them.  I wrote a blog post recently called “Validation as we know it is DEAD”.  In this post, I addressed the challenges and opportunities that cloud and cybersecurity bring.  Although cloud security “solutions” will driving spending by 2021, the solution is not necessarily a technology issue.  You can attack cyber risks effectively with STRATEGY.

For validated systems environments, I am recommending a cybersecurity plan to combat hackers and document your level of due diligence for validated systems.  Remember in validated systems, “…if its not documented, it didn’t happen…”.  You must document you plans and develop an effective strategy for all of your computer systems.

Validation and risk are the power twins of compliance.  Risk management cannot only facilitate the identification of controls to protect your systems long term, it can help ensure compliance and data integrity as well as drive efficiencies in your lean validation processes.  In the conduct of your risk assessments, do not ignore cybersecurity risks – It is the elephant in the room.

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!