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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 ...
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 ...
In an era of increasing regulatory complexity, life sciences organizations are modernizing GxP compliance through digital tools like eQMS, cloud platforms, and automated validation, while expert ...
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 ...
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.