Laboratory Document Control

Document control ensures that personnel use the correct approved procedure and that changes are traceable.

Controlled documents

These may include:

• SOPs
• test methods
• specifications
• forms
• templates
• protocols
• worksheets
• training materials
• software instructions

Approval and versioning

Every controlled document should have a unique identifier, version, effective date, approver, and change history.

Training

Personnel should be trained before a revised procedure becomes effective.

Obsolete versions

Obsolete copies should be removed from active use or clearly marked to prevent accidental use.

Record retention

Retention periods should be defined according to legal, quality, and business requirements.

Frequently asked questions

Is a shared drive enough for document control?

Not by itself. Access, approval, versioning, and archival controls are also required.

Can analysts keep personal copies of old methods?

Uncontrolled copies create risk and should be governed.

Why use effective dates?

They define when a new procedure becomes mandatory.

Should minor editorial changes be documented?

Yes. The change history should remain complete.

Key takeaways

Document control prevents silent procedural drift. Approved versions, training, controlled distribution, and archived history are essential.

References

1. FDA. Data Integrity and Compliance With Drug CGMP: Questions and Answers.
2. OECD Principles of Good Laboratory Practice.
3. ISO/IEC 17025 overview.

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TSMS Labs educational disclaimer: For laboratory research and educational purposes only. Not for human consumption. This content is not medical, clinical, or regulatory advice.