VALGENESIS INC.

ValGenesis, Inc., a market leader in Enterprise Validation Lifecycle Management solutions today announced that one of the world’s top five life...

Having a DRBC program in place, and tested, is a regulatory requirement. During an audit or inspection, the DRBC program can be assessed, with a...

How to accelerate adoption of FDA’s Computer Software Assurance This blog is the first of a three-part series focused on FDA’s Computer Software...

Requirements Traceability Matrix is a regulatory requirement for the life science industry. The Requirements Traceability Matrix (RTM) is a...

In the life science industry, all computer systems with GMP impact must be validated. Computer System Validation is intended to provide...

In the life science industry, all computer systems with GMP impact must be validated. Computer System Validation is intended to provide...

The FDA and European regulators issued recently guidance documents that define the requirements for data integrity for GMP records. Validation...

Cleaning validation is a global regulatory requirement for the life science industry. The purpose of cleaning validation is to establish...

Data integrity is a critical regulatory requirement for the life science industry that is applicable to validation lifecycle. All information...

Data integrity has become a very hot topic in recent years in the regulated industry. Several data integrity guidance documents have been...