In case you missed it, in December 11- 13 KenX conducted the Computer System Validation and Data Integrity Congress. Recently, the FDA has issued warning letters regarding non-compliance of validated computer systems. Findings have included issues such as inadequate risk analysis, non-independent audit trails (audit trails that could be manipulated or turned on/off), failure to established SOPs that provide governance for the validation process and other such issues. The event featured a guest speaker from the FDA who highlighted challenges associated with data integrity and the approach taken by the Agency.
Recently, I have been speaking to the regulatory community about the many challenges we face in validating today’s computer systems. Cybersecurity, mobility, cloud applications at the enterprise level, the Internet of Things (IoT) and many other changes affecting the installation, qualification, deployment and function of computer systems have compelled me to rethink strategies around computer systems validation. As a 30-year practitioner in the field, I have developed key best practices to support cloud validation, address cybersecurity and the other challenges associated with today’s technology.
In case you missed it, I conducted one of the first Computer Systems Validation Master Classes. The Master Class presented a broad range of topics related to the Independent Validation and Verification of today’s technologies. We addressed topics such as:
- Lean Validation Principles, Best Practices and Lessons Learned
- Computer Systems Validation Automation and Best Practicess
- Cybersecurity & Computer Systems Validation: What You Should Know
- Cybersecurity Qualification: The Next Frontier in Validation Testing
- Cloud Validation Best Practices
- Continuous Testing In The Cloud
- Leveraging Service Organization Control (SOC) Reports For Supplier Audits
- … and much more
The 90-minute session was a lively discussion of many topics for validation contemporaries that will help them master validation of the latest technologies and ensure sustained quality and compliance.
Our Master Class format encouraged knowledge-exchange, where each topic was not only debated from the practitioners’ perspective, but participants delivered insights from their experiences presenting the latest best practices, regulatory guidance and practical CSV scenarios resulting in a comprehensive discussion of each topic as well as practical tips, tools and techniques to ensure software quality and a more relevant validation process which takes into account today’s technologies and their profound impact on the validation process writ large.
For participation in the Validation Master Class workshop, I offered participants a copy of my lean validation process templates, a cybersecurity qualification (CyQ) template, a cloud validation SOP, cybersecurity validation SOP, a system risk assessment template and sample SOC 1/SOC2/SOC3 data center reports for cloud providers. (if you would like to obtain a copy of these materials please contact me using the contact form provided)
In case you missed it, I can report that the event was a huge success as measured by the feedback from the session and the response of all participants. Check out our events and join us at one of our weekly webinars or industry events!