Many organizations are adopting Microsoft Dynamics 365® at an accelerated pace. Microsoft Dynamics 365® Enterprise Resource Planning System is an excellent choice for supply chain management within global organizations.
As with any validated system, validation engineers struggled to maintain the validated state. Cloud environments complicate this process in that the validation engineer does not have strict control over the environment. The Microsoft Dynamics 365® is designated as infrastructure as a service and software as a service; as well as platform as a service. Thus, the Microsoft® vendor controls the infrastructure and the provisioning of the environment through what he calls lifecycle services. Further, Microsoft® has a cadence release strategy known as ‘One Version’ which as the name implies ensures that all customers are on one version of the software. Microsoft’s Cadence Release Strategy® is monthly. There are four months each year where there is no cadence release available. However, a monthly strategy for life sciences companies poses some challenges. It will result in continuous testing in the cloud environment if every single release is accepted. For validation engineers this may raise alarm but need not be if this problem is handled appropriately.
So the question is, how does one maintain the validated environment when the application changes so often i.e. monthly? This feat is not impossible but must be done smartly. One answer is to leverage artificial intelligence to streamline, optimize and automate validation testing. Imagine a world where each month a new software release of Microsoft Dynamics® comes out. Further, imagine that in my sandbox environment I am able to summon AI test scripts that will automatically go out using the test scripts developed, interrogate Microsoft Dynamics 365®, run the test scripts, and tell me where the issues are in each new release with no human intervention. This can be done in a matter of hours as opposed to days. Also, imagine a world where each one of the test scripts that are developed will report back the results to a computer system and allow you to re-validate the system in a matter of a few days versus what it would take to do manually months.
Further, imagine if the AI test scripts find errors or issues with the test scripts where Microsoft® has changed functionality from point A to point B, and the system self-heals the test scripts, avoiding the need for expensive validation engineers to come in and rewrite test scripts for every single release. This reality is here. TestMaster™ AI does exactly that. It allows validation engineers to draft automated test scripts for Microsoft Dynamics 365® and these test scripts are self-healing. When the software changes through artificial intelligence and machine learning, the system actually learns the test scripts and self- heals the test scripts. This avoids wasteful time changing test scripts and accelerating the validation process, while ensuring sustained compliance. This is not the purview of the Jetsons, but this is reality for validation testing in the year 2022.
Many validation engineers are still trying to manage cloud technologies in the exact same way that we managed computer systems in the 1980s. That just simply won’t do. There is a need for validation engineers to think out-of-the-box to be able to adopt advanced technologies like Microsoft Dynamics 365® without sacrificing security and compliance.
If you are adopting cloud technologies and would like to adopt them and minimize the burden on validation, it will require fresh thinking on the part of your validation team. Using advanced technologies doesn’t diminish compliance but rather accelerates compliance. The new software validation methodology known by the FDA now as software assurance demands critical thinking. If you are constantly updating your test scripts, then what you are not doing is critically thinking on those things that are most important for your computer systems. You are not critically thinking of those things that could compromise the integrity of your marketed product while using your computer systems. Artificial intelligence and validation are technologies and processes merged together, whose time has come. You need to rethink your 2022 strategies and embrace automation.
Finally, as we are socially distanced in the era of this pandemic, automation is no longer a luxury but a necessity. If you want to streamline and optimize your validation processes using Lean Validation strategies, isn’t it worth a look to see what artificial intelligence and modern technology can do for your validation program?
Check it out! Sign up for demo at www.validationmaster.com.
