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
 Internal audit
 Control of nonconforming product
 Corrective action
 Preventive action
Additional needed documents are:
 Quality policy
 Quality objectives
 Quality manual

4. Draft
Review
Approval
ReleaseTraining
Effective
Follow-up/Monitor
Evaluate

5. How to draft procedures to avoid errors?
clear instructions
written with sufficient details
well understandable
well defined responsibilities
easy to implement

6. 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

7. Documentation usually signed by the following functions:
 Author/owner
 Head of relevant department
 Reviewer
 Approver
 Head of quality/Regulatory department
 Document Control

8.  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.

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
Practices
 An Easy to Understand Guide to Good
Documentation Practices
 Good Laboratory Practices (GLP):
Documenting Deviations & Unexpected
Circumstances