In-house experts can help select the right systems and suppliers, making validation and compliance easy, says Siegfried Schmitt, principal consultant at PAREXEL.

Whether validation performed prior to 2010 was adequate depends on whether or not you complied with the applicable regulations and continue to do so (2). Thus, the expectation by FDA and other ...

Partner Article Computer System Validation – For a consistent and reliable computerized system Computer system validation, popularly known as CSV is the process of procuring documented evidence that ...

This article discusses the computerized system validation and analytical method validation and instrument qualification in thermal analysis.

Incorporating Q8, Q9, Q10 into good manufacturing practices (GMP), guidance on process validation, health based exposure limits covering cleaning validation and computerized system validation are the ...

Computer System Validation is a regulatory requirement under ICH GCP and 21 CFR Part 11 but it also makes good business sense to ensure that computerized systems will perform consistently as expected.

Trained staff who follow written SOPs as well as the instrument operating manual are also considered as being part of the computerized system. From a validation point of view, one distinguishes ...

Research and Markets: E-Learning Course: IT Use and Analytical Validation (Certified) - The Fundamentals of Computerized Systems Validation Are Explained and How it Works ...

In the pharmaceutical industry, a well-planned computerized system validation process helps to build a manufacturing environment in which drugs can be produced that are pure, safe, and effective.