Document control is the systematic process of creating, reviewing, approving, distributing, revising, and retaining documents to ensure accuracy, consistency, and compliance throughout their lifecycle.
Document Control 101: Everything You Need to Know
Document control is a foundational practice for organisations that manage policies, procedures, records, and regulated information. Without effective document control, organisations face compliance risks, operational inefficiencies, and audit failures.
What Is Document Control?
Document control refers to the formal management of documents to ensure that only approved, current versions are in use and that changes are reviewed, authorised, and traceable. It applies across industries, especially in regulated environments.
Why Document Control Is Important
- Prevents use of outdated or incorrect documents
- Ensures consistency across teams and locations
- Supports audits, inspections, and certifications
- Reduces compliance and operational risk
Key Elements of Document Control
- Document creation and standardised templates
- Review and approval workflows
- Version control and revision history
- Access control and permissions
- Retention, archival, and disposal
Documents Commonly Controlled
- Standard Operating Procedures (SOPs)
- Policies and work instructions
- Quality manuals and compliance records
- Training, audit, and change control documents
Document Control Process Explained
- Create: Draft documents using approved templates
- Review: Subject matter experts verify accuracy
- Approve: Authorised stakeholders sign off
- Distribute: Publish controlled versions
- Maintain: Track changes and revisions
- Archive: Retain obsolete documents securely
Manual vs Digital Document Control
- Manual control: Paper files and spreadsheets prone to errors
- Digital control: Centralised systems with automation and audit trails
Document Control in Regulated Industries
Industries such as pharmaceuticals, healthcare, manufacturing, and finance rely on document control to meet standards like ISO, FDA, HIPAA, and GxP. Regulators expect documented evidence of controlled processes.
How Document Control Supports Compliance
Document control ensures traceability, accountability, and integrity of records. Audit trails, approvals, and version history provide verifiable evidence during inspections and audits.
Common Document Control Challenges
- Version confusion and duplicate files
- Manual approvals and delays
- Lack of visibility and accountability
- Audit preparation stress
Best Practices for Effective Document Control
- Standardise templates and naming conventions
- Define clear roles and responsibilities
- Automate workflows where possible
- Maintain audit-ready documentation
Next Steps for Organisations
- Assess current document control maturity
- Identify compliance and governance gaps
- Adopt a modern document management system
Learn how modern document management platforms enable document control by exploring document management software features, book a demo, or contact our team.
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Frequently Asked Questions
What is document control used for?
Document control is used to ensure documents are accurate, approved, current, and traceable throughout their lifecycle.
Is document control mandatory?
Yes. Most quality, regulatory, and compliance standards require formal document control.
Who is responsible for document control?
Responsibility typically lies with quality teams, document controllers, and process owners.
Can document control be automated?
Yes. Modern document management systems automate approvals, versioning, access control, and audit trails.
