The document outlines the importance of documentation in regulated industries, detailing the requirements for effective documentation practices according to ISO 9001:2008. It emphasizes the need for clear procedures, roles, and review processes to ensure quality and compliance, and mentions the various documents that should be maintained. Additionally, it encourages utilizing resources such as webinars for further training on good documentation practices.

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