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.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.Often times, the FDA comes to inspect your facility for reasons other than your CSV program.
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.
The regulation outlines controls for ensuring that electronic records and signatures are trustworthy, reliable, and compatible with FDA procedures and as verifiable and traceable as their paper counterparts.
The lack of consistency in the process creates the risk of not being capable of complying with the requirements of approved procedures.
Val Genesis Validation Lifecycle Management System (VLMS) enables 100% paperless and fully automates the CSV process from initial validation to retirement and decommissioning.
Validation is a critical tool to assure the quality of computer system performance.