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).

We will discuss cloud computing and Software as a Service (SaaS) systems that can be embraced and validated effectively Discuss the best practices for documenting computer system validation efforts, ...

Join this interactive two-day course to master cost-effective computer system validation. Learn the 10-step risk-based approach to cut compliance costs by two-thirds while meeting Part 11 and Annex 11 ...

TheA Risk Based Approach To Data Integrity - Online Webinar Covering Validation/21 CFR 11 Compliance of Computer Systems - ResearchAndMarkets.com ...

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 ...