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 ...

He is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books "Validation and Qualification in Analytical ...

Computer systems subject to GCP requirements must be thoroughly and appropriately validated in accordance with FDA's guidance on computer system validation.

Gain invaluable insights into the nuances of Computer System Validation (CSV), System Development Life Cycle (SDLC) approaches, and 21 CFR Part 11 compliance for electronic records and signatures.

Dublin, Jan. 18, 2024 (GLOBE NEWSWIRE) -- The "Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech" training has been added to ResearchAndMarkets.com's offering.

The Board of the Eurasian Economic Commission has adopted Guidelines on Ensuring Data Integrity and Validation of Computerized Systems. The manual contains recommendations for pharmaceutical ...

The adoption will include all relevant departments, including Regulatory Affairs, ensuring compliance with key regulatory guidelines such as ANVISA's Computerized Systems Validation Guide (No. 33/ ...

GAMP5, the global benchmark in computerized system validation since 2008, has evolved to meet the demands of cutting-edge technologies like Artificial Intelligence, Cloud Computing, and Agile Software ...