This expertise has also been applied to other national security needs.These include ensuring the nonproliferation of nuclear weapons and materials, reducing the threat from chemical and biological weapons, and providing advanced custom designs for other agencies involved in national defense.Many end users rely heavily on vendor-supplied information and test data to support their validation efforts.Validation is a complex, time-consuming procedure involving different qualifications of equipment used in drug development and manufacturing quality control.Even as companies automated their production and quality processes, they were still being forced to maintain and track paper records for FDA acceptance.The code of Federal Regulations (CFR) Part 11 was implemented in 1997 to let the FDA accept electronic records and signatures in place of paper records and handwritten signatures for compliance.In order to comply with c GMP, companies are required to record, track, manage, store and easily access various production documents and their detailed change history including Standard Operating Procedures (SOPs), Master Production Batch Record (MPBR), Production Batch Record (PBR), Equipment log books etc.
Computer-controlled analytical instruments operating in a regulated environment must comply with the requirements of the various good practices, such as Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Manufacturing Practice (GMP).
Extensive validation is still required at installation and at regular intervals throughout a systems life span, to ensure compliance with regulatory demands.
Because of the high degree of automation and the complex systems used in todays laboratory, technology and support are increasingly needed from specialized vendors.
Download a Insight 21CFR part 11 requires that all systems that govern any c GXP process - including Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Good Clinical Practices (GCPs), should be validated.
FDA issued a very comprehensive guidance on systems validation.