Document Control Register – QMS Version & Record Tracking (Excel/PDF)

Document Control Register Template — QMS Document Tracking

Overview

This Document Control Register provides a structured, audit‑ready method for tracking all controlled documents within your QMS.It is designed for pharmaceutical, biotech, medical device, and other regulated environments where version control, traceability, and document governance are critical for compliance.

What’s Included

• PDF version: Document_Control_Register.pdf

• Excel version: Document_Control_Register.xlsx

• Document number and title tracking

• Revision numbers and effective dates

• Departments, owners, and locations

• Status (Active / Obsolete / Draft)

• Notes and metadata for audits

• Revision history section

When to Use This Template

• Managing controlled QMS documentation

• During audits and inspection readiness checks

• For new system implementations

• When establishing a document lifecycle management system

• To replace ad‑hoc or outdated spreadsheets

Why This Template Helps

• Ensures complete oversight of QMS documentation

• Reduces audit findings related to uncontrolled or outdated documents

• Improves visibility across all departments

• Supports electronic or hybrid documentation systems

• Highly flexible and simple to maintain

Compliance Alignment

• GxP, GMP documentation expectations

• ALCOA+ principles (accuracy, traceability, consistency)

• ISO 9001 documentation and revision control clauses

• PIC/S inspection readiness

Cross‑Links

• Data Integrity SOP

• Work Instruction Template

• Master Template Pack (bundle & save)