FDA document control is the structured management of documents and records required to comply with U.S. Food and Drug Administration (FDA) regulations. It ensures documents are approved, current, traceable, and protected throughout their lifecycle.
What Is FDA Document Control?
FDA document control is a foundational requirement for organisations regulated by the FDA, including pharmaceutical, biotechnology, medical device, and life sciences companies. It ensures that regulated documents are accurate, controlled, and audit-ready at all times.
What Is FDA Document Control?
FDA document control refers to the policies, procedures, systems, and controls used to manage documents required under FDA regulations such as 21 CFR Part 11, GMP, and GxP. These controls govern document creation, review, approval, distribution, revision, and retention.
Why FDA Document Control Is Important
- Ensures compliance with FDA regulations
- Prevents use of outdated or unapproved documents
- Maintains data integrity and traceability
- Supports FDA inspections and audits
Examples of FDA-Controlled Documents
- Standard Operating Procedures (SOPs)
- Batch records and manufacturing documentation
- Validation and qualification records
- Training records and deviation reports
Who Needs FDA Document Control?
- Pharmaceutical and biotechnology companies
- Medical device manufacturers
- Contract manufacturing and research organisations
- Life sciences and regulated healthcare organisations
Manual vs Digital FDA Document Control
- Manual control: Paper-based systems prone to errors and compliance risk
- Digital control: Electronic systems with version control, audit trails, and access management
How FDA Document Control Supports Compliance
FDA document control ensures that only approved documents are in use, changes are reviewed and authorised, and complete audit trails are maintained. These controls help organisations demonstrate compliance during FDA inspections.
Next Steps for Organisations
- Identify documents governed by FDA regulations.
- Define approval, change control, and retention rules.
- Adopt a document management system designed for FDA compliance.
Learn how modern document management platforms support FDA document control by exploring document management software features, book a demo, or contact our team.
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Frequently Asked Questions
What is FDA document control used for?
FDA document control is used to manage regulated documents so they remain approved, current, and traceable under FDA regulations.
Is FDA document control mandatory?
Yes. Organisations regulated by the FDA must maintain controlled documentation to demonstrate compliance.
What happens if FDA documents are not properly controlled?
Poor document control can result in FDA observations, warning letters, product recalls, or operational shutdowns.
Can FDA document control be automated?
Yes. Modern document management systems automate approvals, version control, audit trails, and access control for FDA compliance.
