The European Medicines Agency has released a new Annex 11-Computerized Systems to its GMP Guide Chapter 4 on Documentation to account for the increased use of and complexity of computerized systems in ...

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 ...

In January 2011, the European Medicines Agency (EMA) announced the new revision of EudraLex Volume 4 (GMP) - Annex 11 'Computerised Systems', and the consequential amendment of EudraLex Volume 4 - ...

InstantGMP™, a provider of cloud-based GMP and FDA compliance software for pharmaceutical and other regulated manufacturers, announced it has aligned its software development and validation practices ...

Dublin, Nov. 07, 2025 (GLOBE NEWSWIRE) -- The "Computerized Systems Validation, Data Integrity & Cloud Computing In Pharma & Biotech (Dec 9th - Dec 10th, 2025)" training has been added to ...

Although the pharmaceutical industry works to the same regulations there are wide differences in company interpretations. Often the interpretation for CSV can be inflexible, onerous, slow and a ...

Title 21 CFR Part 58 provides guidance on Good Laboratory Practice (GLP) for executing non-clinical laboratory studies that support applications for research permits for Food and Drug Administration ...

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 ...