4. FDA, Guidance for Industry Part 11, Electronic Records; Electronic Signatures--Scope and Application (FDA, August, 2003), accessed July 1, 2015. Article DetailsPharmaceutical Technology Vol. 39, No ...

A risk-based approach The final guidance on General Principles of Software Validation, issued in 2002, states that validation activities should be commensurate with the design complexity and risk ...

Ten-Step Process for COTS Risk-Based Computer System Validation (30 Min) Learn which documents the FDA expects to audit. How to use the risk-based validation approach to lower costs.

Any systems relevant to GxP (‘good practices’) must be validated as fulfilling their intended purpose. Yet, too often, computer system validation (CSV) or assurance (CSA) is treated as a distracting ...

Validating computerized systems is required by regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), for systems used as part of GxP ...

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 ...