Document Control Checklist for Regulated Industries
A document control checklist outlines the essential controls, processes, and governance requirements organizations must implement to manage documents accurately, securely, and in compliance with regulatory standards.
Regulated industries such as pharma, healthcare, BFSI, manufacturing, and life sciences rely on controlled documentation to meet compliance, audit, and quality requirements. This checklist helps assess document control readiness.
Who This Is For
- Quality and compliance teams
- Document control and records management professionals
- Audit and regulatory affairs teams
- Organizations operating in regulated industries
Summary: A document control checklist helps regulated organizations verify that document processes meet compliance, audit, and governance requirements.
Core Document Control Requirements
- Defined document ownership and accountability
- Standardized document classification and naming
- Controlled access and permissions
- Formal review and approval workflows
- Version control and revision history
Compliance and Audit Controls
- Complete audit trails for document actions
- Electronic signatures where required
- Document change and approval records
- Read-only access to approved documents
- Evidence retention for audits
Security and Access Management
- Role-based access control
- User authentication and authorization
- Secure remote document access
- Controlled external sharing
- Monitoring of document usage
Document Lifecycle Management
- Defined creation and review cycles
- Document expiry and review alerts
- Retention schedules and archival rules
- Controlled document retirement
- Legal hold support when required
Operational Best Practices
- Centralized document repository
- Standard templates for regulated documents
- User training on document control procedures
- Periodic document audits and reviews
Common Gaps Identified During Audits
- Use of outdated or uncontrolled documents
- Missing approval or review evidence
- Incomplete audit trails
- Unrestricted access to sensitive documents
Next Steps
- Use this checklist to assess current document control maturity
- Explore document management software features
- Review compliance-driven use cases
- Book a demo to see document control in action
- Contact us for compliance guidance
FAQs
What is a document control checklist?
A document control checklist is a list of required controls and processes to manage documents in a compliant and auditable manner.
Why is document control important in regulated industries?
It ensures accuracy, traceability, and compliance with regulatory and audit requirements.
Who should use a document control checklist?
Quality, compliance, and document control teams in regulated industries should use this checklist.
Does document control support audits?
Yes, strong document control provides the evidence and traceability required during audits.
Can document control be automated?
Automation is recommended to ensure consistency, scalability, and audit readiness.
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