The concepts described herein are common sense and can be applied in any situation.
Requirements
It is a requirement (implicit) for all documents and records required for compliance for companies in a regulated environment – for this course, the life sciences (medical devices, pharmaceuticals, clinical research organizations, etc.)
Sample Documents
A few samples of such documents and records would include:
- Design Input Specifications
- Training Records
- System Hazard Analysis
- Production Batch Records
- Internal Audit Records
- Customer Complaint Records
- Verification & Validation Protocols
- Laboratory reports and worksheets
Hopefully that shows the scope of documents and records for which GDocP should be applied. All of Product (R&D, Production, Post-Market Surveillance / Vigilance), Process, and Quality related documents and records are in scope.
Document Life Cycle
GDocP transcends the entire document lifecycle from initiation, review, approval, execution, cross-references, and attachments through to retirement and retention.
