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 ...

US FDA Electronic Records 21 CFR Part 11, Computerized Systems Health Canada Good Manufacturing Practices (GMP), Guideline GUI-0001 European Union EudraLex Good Manufacturing Practices Vol 4 PIC/s ...

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 ...

Validation of computerised systems is a regulatory requirement for both GMP and GLP laboratories. Although computerised system validation (CSV) has been required for over 40 years, the approaches ...

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 ...

Validated next-generation sequencing soon will become necessary in ensuring the safety and efficacy of cell and gene ...