Why is the definition of the life cycle of QMS documents needed
- establish clear procedures for document creation, approval, review, and archiving.
- ensure document integrity, reliability, and compliance throughout their lifecycle.
- facilitate standardized document management processes within the CTU.
- align periodic review cycle with industry/ GCP best practices, typically within at least a 3-year timeframe.
Audit observations: What was missing?
Periodic review cycle for documents was too long (5 years) and not aligned with GCP best practices.
Recommendations:
- Amend SOP to reflect a periodic review cycle of at least every 3 years.
- Implement standardized procedures for document management, including document identification and approval.
- Implement also standardized procedures that define the
- editing rights for document revision.
- training period for the revised document to ensure proper understanding of the changes.
- appropriate individuals are informed about the new document version and receive the necessary training.