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 ...

System documentation should include a system description, history, validation information, and references, according to Siegfried Schmitt, Vice President, Technical at Parexel. Q. Some 10 years ago, ...

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 ...

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 ...

VANCOUVER, British Columbia--(BUSINESS WIRE)--Elevated Signals, the manufacturing execution system (MES) for the cannabis industry, today announced it is GMP-ready, following third-party validation ...