FDA emphasizes data integrity in its inspections of computer systems within regulated industries, focusing on compliance and consumer safety. This press release covers best practices in system ...

The FDA introduced the framework for computer system validation in 1997 with 21 CFR Part 11, then further refined it in its 2002 guidance document (General Principles of Software Validation).

A straightforward path toward regulatory compliance, data integrity, and computer systems validation Microbial testing, analysis and environmental monitoring is fundamental to safe pharmaceutical ...

DUBLIN-- (BUSINESS WIRE)--The "Computer System Validation for Cloud and COTS Applications-Live Online Training" training has been added to ResearchAndMarkets.com's offering. “Computer System ...

Discuss the regulatory guidance around validation of a microbial testing and identification system in the CGMP environment Explain the details of a microbial identification system designed to meet ...