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 In April 2016 the FDA issued new draft guidance for data integrity and compliance with cGMP.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 […]