Document control software should ensure only approved documents are used, every change is traceable, access is restricted by role, and audits can be completed without scrambling for evidence.
What to Look for in Document Control Software
Choosing document control software is not just an IT decision—it directly affects compliance, quality, operational efficiency, and audit outcomes. Organisations that select tools based only on storage or collaboration often face version chaos, approval gaps, and audit findings.
This guide outlines the essential capabilities to look for when evaluating document control software, especially for regulated or quality-driven environments.
Why Document Control Software Matters
Document control ensures that employees always use the correct, approved version of policies, SOPs, work instructions, and records. Without proper controls, even small document errors can result in compliance violations or operational failures.
Core Capabilities Every Document Control System Must Have
- Strict version control with complete history
- Formal review and approval workflows
- Role-based access control
- Audit trails for every document action
Key Features to Evaluate
1. Version Control & Change History
The system should automatically create a new version for every approved change, preserve prior versions, and clearly identify which version is active.
2. Approval Workflows
Look for configurable approval workflows that enforce review and sign-off before documents become usable. Email-based approvals are not sufficient for audit readiness.
3. Role-Based Access Control
The software must restrict who can view, edit, approve, or delete documents based on defined roles—ensuring segregation of duties.
4. Audit Trails & Traceability
Every upload, edit, approval, and download should be logged automatically. Auditors expect objective, system-generated evidence.
5. Document Lifecycle Management
Documents should move through controlled states such as draft, under review, approved, obsolete, and archived—preventing outdated content from remaining in use.
Advanced Capabilities Worth Considering
- Automated review and expiry reminders
- Change request and impact assessment workflows
- Metadata and classification for fast retrieval
- Dashboards for compliance and audit readiness
Document Control in Regulated Industries
Industries such as manufacturing, pharmaceuticals, healthcare, BFSI, and food & beverage require stronger controls. Document control software should support ISO, FDA, GxP, HIPAA, and audit expectations without heavy customisation.
What to Avoid When Choosing Document Control Software
- Tools focused only on file storage or collaboration
- Manual approvals outside the system
- Lack of audit trails or reporting
- Overly complex configuration for basic controls
Scalability & Adoption Considerations
A good document control system should scale across departments and locations while remaining easy for end users. Overly complex tools often fail due to poor adoption.
Summary: The right document control software enforces version accuracy, approvals, access control, and traceability—turning document governance into a built-in process rather than a manual burden.
From Evaluation to Implementation
Once evaluation criteria are clear, organisations can move confidently toward implementation—starting with high-risk documents such as SOPs, policies, and quality records.
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Frequently Asked Questions
What is document control software?
It is software designed to manage document versions, approvals, access, and audit trails to ensure controlled document use.
Is document control software different from file storage?
Yes. File storage focuses on saving files, while document control enforces governance, approvals, and compliance.
Do small organisations need document control software?
Yes. Even small teams benefit from version control and approval discipline as they scale.
Is document control required for audits?
In regulated environments, auditors expect evidence of controlled documents and approvals.
