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 […]
Is Your Validation Team Ready For GDPR?
GDPR stands for the General Data Protection Regulation. It governs all personal data collected by companies for customers, potential customers, employees, and others. Regulators are keen to understand how this information is managed and maintained over time. In April 2016 the FDA issued new draft guidance for data integrity and compliance with cGMP. The guidance […]
Validating Microsoft Dynamics 365: What You Should Know
Microsoft Dynamics 365 and Azure are gaining popularity within the life sciences industry. I am often asked the question about how to validate such a system given its complexity and cloud-based nature. The purpose of this blog post is to answer this question. The outline of this blog post is as follows. Understanding the Changing […]
Cybersecurity Qualification (CyQ)
One topic that has been top of mine for many validation engineers, chief information officers, and executive management is that of Cybersecurity. You may be asking yourself the question why are we talking about Cybersecurity and validation? Recent headlines will inform you as to why this topic should be of great interest to every validation […]
