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 ...

When implementing computerized systems, it is important that both purchasers and vendors ensure that each stage of the process (from planning through operation to modifying) is properly validated.

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 ...

EU good manufacturing practice (GMP) Annex 11 regulation on computerized systems has been effective since 1992. 1 Following the data falsification uncovered at Able Laboratories in 2005, 2 many data ...

In the pharmaceutical and biotechnology sector, validation is a mandated practice integral to the entire drug development process, particularly in the context of computerized systems and manufacturing ...

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 ...

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 ...