SharePoint Validation: Quality and Compliance Portals

I am often asked the question… “can SharePoint be validated?”  The short answer is YES but it often requires customization to achieve deliver compliance objectives.  The longer response requires further examination as to why people ask the question and the nature of SharePoint as a content management system.  With the release of Office 365® reaching over […]

Women in Validation: In Case You Missed It

One of my annual “must attend” events is the Institute of Validation Technology (IVT) Computer Systems Validation Annual Validation Week in October.  This is an excellent event to get the latest and greatest thinking on validation topics and industry guidance.  An official from the U.S. FDA attended the event and providing key information on the […]

Can Microsoft Azure Be Validated?

The text book definition of computer systems validation (paraphrased) is “documented evidence that a system performs according to its intended use”.  The FDA uses the definition “…Validation is a process of demonstrating, through documented evidence, that <software applications> will consistently produce the results that meets predetermined specifications and quality attributes.” Using the FDA’s definition, one […]

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 […]

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 […]

Cloud Validation Strategies

If you were to ask me 10 years ago how many of my life sciences clients were deploying systems in the cloud environment I would’ve said may be perhaps one or two. If you ask me today how many of my clients are deploying cloud’s technologies I would say most all of them in one […]

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 […]

How Vulnerable Is Your Validated System Environment?

If you are a validation engineer reading this post, I have a simple question to ask you.. “How vulnerable is your validated systems environment?”  Has anyone ever asked you this question?  How often do you think about the impact of a cyber threat against your validated computer system?  I know… you may be thinking that […]