Documentation & Records (GDocP) — Overview

Good Documentation Practice (GDocP) is the set of rules that governs how you write, control, and keep the records that prove your operation is compliant. If it is not documented, in the eyes of a regulator it did not happen.

This section is the foundation for every other section — every process, test, and decision needs a document or record.

What this section covers

• What GDocP is and the ALCOA+ principles (ALCOA+)
• The difference between a document (instruction) and a record (evidence)
• Document control — how to write, approve, version, and retire documents
• Standard Operating Procedure (SOP) lifecycle
• Record keeping — how to fill in, store, and protect records
• Data integrity — preventing and detecting falsification
• Electronic versus paper records — rules and risks
• Retention periods — how long to keep what
• General templates that cover essential requirements