As we open the new year with resolutions and new fresh thinking, I wanted to offer 10 best practices that should be adopted by every validation team. The major challenges facing validation engineers every day include cyber threats against validated computer systems, data integrity issues, maintaining the validated state, cloud validation techniques and a myriad of other issues that affect validated systems.
I have been championing the concept of validation maturity and lean validation throughout the validation community. In my recent blog post, I highlighted reasons why validation as we have known it over the past 40 years is dead. Of course I mean this with a bit of tongue in cheek.
The strategies included in the FDA guidance and those we used to validate enterprise systems in the past do not adequately address topics of IoT, cloud technologies, cybersecurity, enterprise apps, mobility and other deployment strategies such as Agile change the way we think and manage validated systems.
The following paragraphs highlight the top 10 best practices that should be embraced for validated computer systems in 2018.
Practice 1 – Embrace Lean Validation Best Practices
Lean validation is the practice of eliminating waste and inefficiencies throughout the validation process while optimizing the process and ensuring compliance. Lean validation is derived from lean manufacturing practices where non-value-added activity is eliminated. As a best practice it is good to embrace lean validation within your processes. To fully embrace lean it is necessary to automate your validation processes thus it is strongly recommended that automation be part of your consideration for updating your validation processes in 2018. My recent blog post on lean validation discusses lean in detail and how it can help you not only optimize your validation process but achieve compliance
Practice 2 – Establish Cybersecurity Qualification and SOP
I have noted in previous lock posts that cyber threats were the elephant in the room. Although validation engineers pledge to confirm that the system meets its intended use through the validation process, many organizations do not consider cyber security is a clear and present danger to validated systems. I believe that this is a significant oversight in many validation processes. Thus, I have developed a fourth leg for validation called cyber security qualification or CyQ. Cyber security qualification is an assessment of the readiness of your processes and controls to protect against a cyber event. It includes testing to confirm the effectiveness and the strength of your controls. In addition to IQ, OQ, and PQ, I have added CyQ as the fourth leg of my validation. It is strongly recommended in 2018 that you consider this best practice.
Practice 3 – Automate Validation Testing Processes
In the year 2018, many validation processes are still paper-based. Companies are still generating test scripts using Microsoft Excel or Microsoft Word and manually tracing test scripts to requirements. This is not only time-consuming but very inefficient and causes validation engineers to focus more on formatting test cases rather than finding bugs and other software anomalies that could affect the successful operation of the system. Lean validation requires an embrace of automated testing systems. While there are many point solutions on the market that address different aspects of validation testing, for 2018 it is strongly recommended that you embrace enterprise validation management as part of your overall strategy. An enterprise validation management such as ValidationMaster manage this the full lifecycle of computer systems validation. In addition to managing requirements (user, functional, design), the system also facilitates automated testing, incident management, release management, and agile software project methodologies. In 2018, the time has come to develop a Reusable Test Script Library to support future regression testing and maintaining the validated state.
An enterprise validation management system will also offer a single source of truth for validation and validation testing assets. This is no longer a luxury but mandatory when you consider the requirement for continuous testing in the cloud. This is a best practice whose time has come. In 2018, establish automated validation processes to help maintain the validated state and ensure software quality.
Practice 4 – Develop a Cloud Management For Validated Systems SOP
many of today’s applications are deployed in the cloud. Office 365, dynamics 365 and other such applications have gained prominence and popularity within life sciences companies. In 2018, you must have a cloud management standard operating procedure that provides governance for all cloud activities. This SOP should define how you acquire cloud technologies and what your specific requirements are. Failure to have such an SOP is failure to understand and effectively manage cloud technologies for validated systems. I have often heard from validation engineers that since you are in the cloud the principles of validation no longer apply. This is absolutely not true. In a cloud environment, the principles of validation endure. You still must qualify cloud environments and the responsibilities between yourself and the cloud provider must be clearly defined. If you don’t have a cloud SOP or don’t know where to start in writing one, write me and I will send you a baseline procedure.
Practice 5 – Establish Validation Metrics and KPIs
Peter Drucker said you can’t improve what you can’t measure. It is very important that you establish validation metrics and key performance indicators in 2018 for your validation process. You need to define what success looks like. How will you know when you’ve achieved or objectives? Some key performance indicators may include the number of errors, the number of systems validated, the number of incidents (this should be trending downward), and other such measures. Our ValidationMaster™ portal allows you to establish KPIs for validation and track them over time. In 2018 it’s important to embrace this concept. I have found over the years that most validation activities are not looked at from a performance perspective. They are often inefficient and time-consuming and no one actually measures the value to the organization regarding validation or any key performance indicators. The time is come to start looking at this and measuring it as is appropriate.
Practice 6 – Use Validation Accelerators For Enterprise Systems
Across the globe validation engineers are being asked to do more with less. Organizations are demanding greater productivity and compliance. As you look at enterprise technologies such as Microsoft Dynamics 365®, you need to consider the importance of this environment and how it should be validated. There is a learning curve with any enterprise technology. You should recognize that although you may know a lot about validating a system you may not know specifically about this technology and the ends and outs of this technology. The FDA stipulates and their guidance that you may use vendor information as a starting point for validation. Understand that there’s no such thing as validation out of the box therefore you must do your due diligence when it comes to validated systems.
In 2018 we recommend that for systems such as Microsoft Dynamics 365, BatchMaster™, Edgewater Fullscope EDGE®, Veeva® ECM systems, Oracle e-Business®, and many others, that you use a Validation Accelerator to jumpstart your validation process. Onshore Technology Group offers Validation Accelerators for the aforementioned software applications that will help streamline the validation process. Most noteworthy, our validation accelerators come bundled with a full enterprise validation management system, ValidationMaster. This helps to deliver a single source of truth for validation.
Practice 7 – Fill Staffing Gaps With Experts on Demand
In 2018, you may find yourself in need of validation expertise for your upcoming projects but may not have sufficient resources internally to fulfill those needs. A burgeoning trend today is the outsourcing of validation staff to achieve your objectives – validation staffing on demand. OnShore offers an exclusive service known as ValidationOffice℠ which provides validation team members on demand. We recruit and retain top talent for your next validation project. We offer a validation engineers, technical writers, validation project managers, validation test engineers, validation team leaders, and other such staff with deep domain experience and validation confidence. In 2018 you may want to forgo direct hires and use ValidationOffice℠ to fulfill your next staffing need.
Practice 8 – Establish Validation Test Script Library
One of the primary challenges with validation testing is that of regression testing. Once a system is validated and brought into production any software changes, patches, updates, or other required changes drive the need for regression testing. This often results in a full rewrite of manual, paper-based test scripts. Today’s validation engineers have tools at their disposal that eliminates the need for rewrite of test scripts and the ability to pull test scripts required for regression testing from a reusable test script Library. This is the agile, lean way to conduct validation testing. In 2018, you should consider purchasing an enterprise validation management system to manage a reusable test script Library. This is a process that will save you both time and money in the development and online execution of validation test scripts.
Your test scripts can be either fully automated or semi-automated. Fully automated test scripts can be run automatically with no human intervention. Semi-automated validation test scripts are used by the validation engineer to conduct validation testing online. It should be noted that ValidationMaster supports both. Check out demo to learn more about how this works.
Practice 9 – Develop a Strategy For Data Integrity
The buzzword for 2018 is data integrity. Europe just announced its GDPR regulations for data integrity. The new regulations hold you accountable for the integrity of data in your system and the privacy of information housed therein. In 2018 it is imperative that you have a data integrity strategy and that you look at the regulations surrounding data integrity to ensure that you comply. In the old days when we used to do validation, it was left up to each validation engineer when they would do system updates and how often they would validate their systems. Data integrity and cyber security as well as cloud validation demand strategies that include continuous testing. I discuss this in a previous blog post but it is very important that you consider testing your systems often to achieve a high level of integrity not only of the application but of the data.
Practice 10 – Commit to Achieve Level 5 Validation Process Maturity
Finally, your validation processes must mature in 2018. It is no longer acceptable or feasible in most organizations that are attempting to improve efficiency and compliance to simply continue with antiquated, inefficient paper-based systems. Therefore in 2018 it will be important for you to commit to Level 5 validation process maturity where your processes are automated and you have greater control over your validated systems and sustain quality across the validation lifecycle. Check out my other post on achieving Level 5 process maturity.
I wish you all the best in 2018 as you endeavor to establish and maintain the validated state for computer systems. From the development of Level 5 validation processes through automation it’s important to understand the changes that new technology brings and how well you and your organization can adapt to those changes. Your success depends on it! Good luck and keep in touch!