How do I ensure my claims and labeling review with document control system software is compliant?

To keep claims and labeling review compliant in a document control system (DCS), you want the software process to support the same core principles regulators expect: controlled content, traceable review, approved versioning, and complete audit evidence.

Here’s a practical compliance checklist:

1) Define a controlled workflow

Make sure the system enforces a documented workflow for:

• Draft creation
• Review
• Approval
• Final release
• Revision / change control
• Obsolescence of old versions

A compliant system should prevent unapproved documents from being used.

2) Use role-based access

Limit who can:

• Create claims or labeling content
• Review or edit
• Approve
• Release to production or external use

This helps ensure only authorized personnel can make regulated changes.

3) Maintain full version control

Your DCS should:

• Number versions automatically
• Keep prior versions archived
• Show what changed between versions
• Prevent accidental overwriting

For claims and labeling, this is critical because even minor wording changes can affect compliance.

4) Capture approvals with audit trails

Every action should be time-stamped and attributable:

• Who reviewed
• Who approved
• What was approved
• When it was approved
• Any comments or exceptions

Use electronic signatures only if they meet applicable requirements, such as 21 CFR Part 11 where relevant.

5) Link claims to evidence

Every product claim should be traceable to:

• Scientific substantiation
• Test reports
• Clinical data
• Regulatory references
• Internal justification

Your labeling review process should verify that claims are not unsupported, misleading, or inconsistent with approved evidence.

6) Include regulatory and legal review

For claims and labeling, reviews often need input from:

• Regulatory Affairs
• Legal/Compliance
• Quality
• Marketing/Medical, as applicable

The workflow should require these signoffs before release.

7) Control templates and standard language

Use approved templates, boilerplate, and claim libraries to reduce risk of unauthorized wording.

If the software supports it, lock critical text fields or manage them as controlled content.

8) Validate the document control system

If the software is used for regulated records, it should be validated to show it performs as intended.

Validation usually includes:

• User requirements
• Risk assessment
• Test scripts
• Evidence of correct function
• Change control for software updates

9) Train users

Documented procedures are not enough if users don’t follow them. Train staff on:

• How to submit claims/labeling for review
• How to use the system correctly
• What constitutes an approved claim
• How to handle deviations or urgent changes

Keep training records.

10) Periodically audit the process

Review:

• Approvals completed on time
• Missing substantiation
• Use of obsolete labels/claims
• Unauthorized edits
• Audit trail completeness
• Policy deviations

Internal audits help catch issues before regulators do.

11) Ensure retention and retrieval

You should be able to quickly retrieve:

• Final approved versions
• Review comments
• Approval history
• Supporting evidence
• Superseded versions

Retention periods should match applicable regulatory and company requirements.

12) Match requirements to your industry

Specific compliance expectations depend on your sector:

• Pharma / biotech: FDA, EMA, GxP, Part 11
• Medical devices: labeling controls, DHF/DMR, design controls
• Food / supplements / cosmetics: advertising and labeling laws, substantiation standards
• Consumer products: FTC and product safety rules

If you tell me your industry, I can tailor the requirements.

Quick “is my system compliant?” test

Your review process is in good shape if the software can answer:

• Who changed the claim?
• Who approved it?
• What evidence supports it?
• Which version is current?
• Can old versions still be accessed?
• Can unauthorized changes be prevented?
• Is there a complete audit trail?

If you want, I can also provide:

1. a compliance checklist for claims and labeling review,
2. a SOP template, or
3. a validation checklist for document control software.