Change Management is Essential to Maintaining a Validated State [Video]
This is one of the most critical processes and impacts validation up one side...
Commercial Software Can Never Be Pre-Validated [Video]
If you see a commercial software company advertising their software as pre-validated, that really...
3 Critical Topics Your CSV Release Documentation Needs [Video]
Many times, when software development is commissioned, there will be a point where the...
6 Critical Controls for CSV Change Management [Video]
Such changes also apply to patches and other “less direct” changes! We’ve mostly been...
Why Change Management is Critical to Software Validation (CSV) [Video]
This is one of the most critical processes and impacts validation up one side...
The 6 Quality Attributes Required to Create Solid User Requirements [Video]
Requirements come in all forms. These can include: Functional requirements Language requirements (you may...
Software Configuration in a Regulated Environment – 1 Minute Guide [Video]
Release documentation needs to contain configuration information to ensure that your installation aligns with...
GAMP®5 Roles and Responsibilities Simplified – Process Owner [Video]
GAMP® 5 defines a set of fairly typical roles in validation. While there’s nothing...
The Difference Between the Waterfall and Agile Approach to Software Development [Video]
The software life cycle should align with the company’s QMS and should be maintained...
7 Key Principles of GAMP®5 for Computer System Validation [Video]
Often, industry groups will publish recommendations with best practices for specific activities. Here are...