Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems. Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for ...

Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex ...

Computer system validation, popularly known as CSV is the process of procuring documented evidence that ensures the consistent performance of a computerised system as required by the operational ...

(MENAFN- GlobeNewsWire - Nasdaq) Dublin, Jan. 17, 2024 (GLOBE NEWSWIRE) -- The "FDA Compliance and Clinical Trial Computer System Validation Course" training has been added to ResearchAndMarkets's ...

In this webinar, you’ll learn about the importance of computer system validation (CSV), how frequently it should be performed, and the benefits it can have to help meet FDA regulations and quality ...

Dublin, Dec. 01, 2021 (GLOBE NEWSWIRE) -- Less than two weeks to register for the "Computer System Validation (CSV) Training" training course has been added to ResearchAndMarkets.com's offering. This ...

The "Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech (Dec 9th - Dec 10th, 2025)" training has been added to ResearchAndMarkets.com's offering. Advancements in ...

On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

In-house experts can help select the right systems and suppliers, making validation and compliance easy, says Siegfried Schmitt, principal consultant at PAREXEL. Q. We are planning to upgrade several ...