13
Nov

Seminar on Validation and Part 11 Compliance of Computer Systems and Data at Hong Kong


Congres médical/Evénement qui aura lieu le : 2015-12-07 : Spécialité: Acupuncture

Overview:

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 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory are records are on target of inspectors. The large number of warning letters issued to laboratories also demonstrate that they struggle with either understanding or implementing the regulations.
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