Glossary · Document and evidence governance
Controlled document
In quality and document management, a controlled document is a document managed under defined rules for approval, versioning, access, distribution and change, so that users can rely on having the current, approved version.
- Technical documentation
- Compliance
In one sentence
A controlled document is managed under defined approval, version, access, distribution and change rules so users get the current approved version.
Example
The lockout/tagout procedure for a press line is a controlled document: it has an owner, a revision number, an approval record, and printed copies at the machine are replaced when a new revision is released.
How it applies
- Technical documentation: Manuals, safety instructions, maintenance procedures and risk assessments should be controlled documents. So should the templates and approved warning texts they are built from.
- Printed and exported copies: Uncontrolled copies are the weak point. Mark printouts and PDFs with their revision and status, or label them “uncontrolled when printed”, and define how copies at the machine are replaced.
- Metadata: Status values such as draft, in review, released and withdrawn should be machine-readable, for example with iiRDS ContentLifeCycleStatus, so that portals and assistants can filter out non-released content.
- Evidence: Each revision needs an audit trail: who changed it, why, and who approved it.
Controlled document vs. record
A controlled document tells people what to do and changes through revisions. A record documents what was done, such as a completed inspection checklist, and must not be changed afterward. Both are managed under document control, with different rules.