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.