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 […]
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 In April 2016 the FDA issued new draft guidance for data integrity and compliance with cGMP.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 […]
What Data Integrity Means For Validation
After much fanfare, the general data protection regulations (GDPR) was approved by the EU parliament on April 14, 2016. The enforcement date for this regulation is May 25, 2018. If companies are not in compliance at that time the potential for heavy fines is inevitable. The EU general data protection regulation replaces the data protection […]
