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 ...

Discover the latest updates in GAMP®5's 2nd Edition, designed to tackle modern technologies like AI and Cloud Computing. It emphasizes robust Computer System Validation (CSV) and aligning with FDA's ...

ECE 19 September 2023 18:08 The Board of the Eurasian Economic Commission has adopted Guidelines on Ensuring Data Integrity and Validation of Computerized Systems. The manual contains recommendations ...

Elevated Signals, the manufacturing execution system (MES) for the cannabis industry, today announced it is GMP-ready.

Incorporating Q8, Q9, Q10 into good manufacturing practices (GMP), guidance on process validation, health based exposure limits covering cleaning validation and computerized system validation are the ...

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 ...

Conclusion Annex 11 has been an unchanged computer system validation (CSV) supplement of EudraLex GMP since 1993, but the 2011 revision brings it up to date with the current state of the scientific ...

Burlingame, June 12, 2023 (GLOBE NEWSWIRE) -- According to Coherent Market Insights, global computer system validation market is estimated to be valued at US$ 3.39 billion in 2022 and is expected ...