GDP Training: How to Manage Documentation Lifecycle?
What is Documentation? Documentation is : ď ˝ A set of documents (written or graphical procedures, manuals, policies , instructions, specifications) and records (recorded information of performed activity). ď ˝ A process that involves the systematic interaction of people, events and documents to create the records. Quality can not be assured in a regulated industry without good documentation practices.
Documentation Requirements ISO 9001:2008 specifically requires the organization to have documented procedures for the following six activities:
Control of documents Control of records Internal audit Control of nonconforming product Corrective action Preventive action
Additional needed documents are:
Quality policy Quality objectives Quality manual
The Documentation Management Cycle Evaluate
Draft
Follow-up/Monitor
Review
Effective
Approval
Training
Release
Documentation Management: Documentation Preparation How to draft procedures to avoid errors? clear instructions written with sufficient details well understandable well defined responsibilities easy to implement
Documentation Management: Document Review
What can be reviewed and evaluated when checking individual documents? the information that is stated the information that is not stated requirements legal/regulatory issues safety/risk analysis the rationale of document
Documentation Management: Document Approval
Documentation usually signed by the following functions: Author/owner Head of relevant department Reviewer Approver Head of quality/Regulatory department Document Control
Documentation Management Best Practices
Document management system needs to be clear and logical.
Use a top down approach (QA must take the lead) Use flow chart and other tools to define documentation needs Includes all types of documentation (including electronic) Ensure a robust document cycle from drafting to archiving.
Review and evaluate the performance of documentation system.
Want to learn more about GDP, its requirements and best practices to comply with them? ComplianceOnline webinars and seminars are a great training resource. Check out the following links: How to Comply with GDP Requirements? Good Documentation Practices for GXPs
Introduction to FDA Good Documentation Practices
An Easy to
Understand Guide to Good Documentation Practices
Good Laboratory Practices (GLP): Documenting Devi