Document Control and Electronic Signatures for ISO 13485 and FDA 21 CFR Part 11
Controlled documents. Clear approvals. Audit-ready by default.
All QMS and design documents are managed in one controlled system — versioned, traceable, and approved with compliant electronic signatures. Teams always know what’s current, what’s approved, and what’s linked.
One controlled source for every document
If it’s not controlled, it’s a risk.
All SOPs, policies, records, and design documents live in a single, version-controlled repository.
No duplicate files. No guessing which version is valid.
This removes:
- Outdated documents in use
- Parallel edits
- Manual document master lists
When everyone trusts the system, compliance stops depending on memory.
Approvals that guide work — not block it
Documents move through structured review and approval flows, with clear ownership and traceability.
Teams can use simple single-approver reviews or define custom approval workflows when more control is needed.
Everyone knows who reviews, who approves, and what happens next.
Included by default:
- Clear document status at every step
- Flexible approval setup (single approver or workflow-based)
- Complete approval and signature history
Compliant electronic signatures (FDA 21 CFR Part 11)
Sign once. Prove forever.
Electronic signatures are embedded directly into document workflows and aligned with FDA 21 CFR Part 11 expectations.
Each signature is securely linked to:
- A specific document version
- User identity and role
- Date, time, and action
No separate tools. No missing evidence.
Control is not just about approval — it’s about real-time validity.
Approved Documents with Built-In QR Status Verification
Within an approved document, you can include a QR code that, when scanned, displays the current live status of that document.
In addition, each document provides:
- Approval expiration date (if applicable)
- Full revision list
- Complete approval history
- Approval date
Both the revision and approval lists display the name and surname of the responsible person, the specific version or revision number, the date and time of the action, and the comment provided during review or approval.
This ensures full visibility of the document lifecycle — directly from the document itself.
Be confident in every document you show an auditor
See how Document Control and Electronic Signatures stay connected to your Technical File, Quality Events, and full traceability.
Document Control and Electronic Signatures — What Auditors Actually Look For
What is Document Control in an ISO 13485 QMS?
Document Control is the structured management of SOPs, policies, records, and design documents so that every document is versioned, approved, traceable, and current. In an ISO 13485 environment, Document Control ensures that only approved versions are in use, changes are tracked, and full revision history is maintained.
How do Electronic Signatures support FDA 21 CFR Part 11 compliance?
Electronic Signatures aligned with FDA 21 CFR Part 11 securely link each approval to:
- A specific document version
- The signer’s identity and role
- Date, time, and action
This creates a legally defensible audit trail without separate tools or manual signature tracking.
How does version control prevent audit findings?
Version control eliminates:
- Outdated SOPs in circulation
- Parallel document edits
- Confusion about current revisions
Each document has a clear status, full revision history, and controlled approval workflow, ensuring auditors always see the correct, approved version.
Can approval workflows be customized?
Yes. Document workflows can be configured as:
- Single-approver reviews
- Multi-step approval workflows
- Role-based approval chains
This ensures the approval process matches your regulatory and organizational requirements without slowing operations.
What evidence does an auditor expect to see?
Auditors expect proof of:
- Controlled versions
- Defined approval workflows
- Electronic signature traceability
- Clear document status
- Linked corrective or change actions
Effective Document Control demonstrates that documentation is managed continuously — not prepared just before the audit.
How does integrated Document Control reduce compliance risk?
By managing documents within a single controlled system, teams avoid:
- Manual document master lists
- Lost approval history
- Missing evidence during inspections
Control happens during daily work, which keeps the organization permanently audit-ready.
Is this suitable for MedTech companies under ISO 13485 and FDA regulations?
Yes. Document Control and Electronic Signatures are designed specifically for regulated MedTech environments, supporting:
- ISO 13485:2016
- FDA 21 CFR Part 11
- FDA 21 CFR Part 820
- EU MDR documentation expectations
The result is a defensible, connected, and always audit-ready documentation system.
