Controlled documents are officially approved documents that are managed under strict version control, access permissions, and approval workflows. They ensure only the latest, authorised versions are used, supporting compliance, quality, and operational consistency.
What Are Controlled Documents?
Controlled documents are documents that must follow defined rules for creation, review, approval, distribution, revision, and archival. They are commonly used in regulated and quality-driven environments to prevent errors and ensure traceability.
What Are Controlled Documents?
Controlled documents are documents whose content, format, access, and lifecycle are formally governed. Any change to a controlled document requires review and approval, and every version is tracked to maintain a complete audit trail.
Why Controlled Documents Are Important
- Ensure employees use only approved and current documents
- Prevent unauthorised edits and document misuse
- Provide traceability for audits and inspections
- Support regulatory and quality compliance
Examples of Controlled Documents
- Standard Operating Procedures (SOPs)
- Policies and work instructions
- Quality manuals and forms
- Regulatory and compliance documentation
Where Controlled Documents Are Used
- Pharmaceutical and life sciences organisations
- Healthcare and medical device companies
- Manufacturing and quality management systems
- Finance, IT, and regulated enterprise operations
Controlled vs Uncontrolled Documents
- Uncontrolled documents: Files shared via
