In Case You Missed It: CSV Validation Master Class

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 […]

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 […]

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 […]

Accelerating Validation: 10 Best Practices You Should Know in 2018

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 […]

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 […]

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, […]

Automated Validation Best Practices

Automation is the key to lean validation practices.  Although many validation processes are still paper-based manual processes, there are best practices that support Independent Verification and Validation (IV&V) processes that drive efficiency and compliance. BEST PRACTICE 1 – Establish Independence The IEEE 1012 Standard For System, Software and Hardware Verification and Validation states that Independent […]