2. Documentation is :
A set of documents (written or graphical procedures,
manuals, policies , instructions, specifications) and
records (recorded information of performed activity).
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.
3. ISO 9001:2008 specifically requires the organization to have documented
procedures for the following six activities:
Control of documents
Control of records
Control of nonconforming product
Additional needed documents are:
5. How to draft procedures to avoid errors?
written with sufficient details
well defined responsibilities
easy to implement
6. What can be reviewed and evaluated when checking individual
the information that is stated
the information that is not stated
the rationale of document
7. Documentation usually signed by the following functions:
Head of relevant department
Head of quality/Regulatory department
8. Document management system needs to be clear and
Use a top down approach (QA must take the lead)
Use flow chart and other tools to define documentation
Includes all types of documentation (including
Ensure a robust document cycle from drafting to
Review and evaluate the performance of
9. 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
An Easy to Understand Guide to Good
Good Laboratory Practices (GLP):
Documenting Deviations & Unexpected