Skip to content
Request a demo
PlatformModulesIndustriesSecurityPricingInsights Request a demo

Document & revision control

One controlled copy. Every revision, signed and traceable.

Controlled documents, drawings, and procedures with full revision history, electronic signatures, and enforced read-and-understand acknowledgment - so the floor always runs the current rev, and every change carries an audit trail you can defend.

Request a demo See all 205+ features
1
Controlled copy of record
100%
Revisions audit-trailed
21 CFR Part 11
E-signature ready
Air-gapped
Deployment option

The challenge

  • !Operators work from stale PDFs and printed drawings while the current rev sits unread on a shared drive
  • !Document changes have no enforced review, approval, or signature trail when the auditor asks who changed what and why
  • !Training and acknowledgment of revised procedures is tracked in spreadsheets, if at all
  • !Engineering changes update a drawing but never reach the work instructions, travelers, and inspection plans that reference it

What it does

  • Single controlled copy of record for every document, drawing, SOP, and form, with superseded revisions retired automatically so the floor only sees the current rev
  • Full revision history with version compare, change reason, effective date, and a complete who-changed-what-when audit trail
  • Configurable review-and-approval workflows with electronic signatures meeting FDA 21 CFR Part 11 expectations
  • Read-and-understand acknowledgment that routes revised procedures to affected roles and records who has trained to the current rev
  • AI-assisted document classification, metadata extraction, and natural-language search across the controlled library
  • Controlled distribution with watermarked, expiry-stamped copies and retention and disposition rules per document type

Inside the module

Every capability, included.

Document library
Controlled copies
Revision history
Version compare
Change reason capture
Effective dating
Document numbering
Document types & categories
Review workflows
Approval routing
Electronic signatures
Signature manifests
Read-and-understand acknowledgment
Training-to-rev tracking
Distribution control
Watermarking
Copy expiry stamping
Obsolete-rev retirement
Check-in / check-out
Access permissions
Drawing & CAD attachments
Engineering change links
Document linking & references
Full-text & AI search
Metadata extraction
Retention & disposition schedules
Document audit log
Periodic review reminders
Templates & forms
External-document control
ITAR document marking

The intelligence

AI that keeps the library honest.

Auto-classification

New documents are read, classified by type, and tagged with extracted metadata, so the library stays organized without someone hand-filing every file.

Natural-language search

Ask for a procedure by what it does, not by document number - semantic search returns the current controlled rev with its approval status in view.

Change-impact awareness

When a drawing or procedure is revised, linked work instructions, travelers, and inspection plans are surfaced so nothing downstream is left on the old rev.

Built for audits

Evidence captured as you work.

Every revision, review, approval, signature, and acknowledgment is recorded against the document of record. When a registrar or government auditor asks for the change history, the trained-to-rev roster, or proof the floor was running the current procedure, it is one query - not a week of reconstruction.

Time-stamped, attributable electronic signatures with signature manifests

Complete revision and access audit log per document

Retention and disposition schedules enforced per document type

ITAR and export-control marking with permission-scoped access and air-gapped deployment

Connected across the platform

One source of truth.

Quality / QMS

Controlled SOPs, inspection plans, and forms are governed here, so a CAPA or nonconformance that triggers a procedure change flows through the same review-and-sign workflow.

Production

Work instructions, travelers, and setup sheets always render the current rev at the workstation, so the floor cannot run a superseded procedure.

Maintenance / CMMS

Equipment manuals, calibration procedures, and maintenance SOPs stay version-controlled and linked to the assets and work orders that reference them.

Standards & compliance

Built in, not bolted on.

FDA 21 CFR Part 11AS9100 Rev DISO 9001:2015IATF 16949ITAR (22 CFR 120-130)CMMC 2.0 Level 2

FAQ

Questions, answered.

How does Cortrova make sure the floor is always on the current revision?

Each document has a single controlled copy of record. When a new rev is approved and made effective, the prior rev is retired automatically and disappears from the workstation view. Work instructions, travelers, and setup sheets render the current controlled rev in place, so an operator cannot pull up or print a superseded procedure.

Are the electronic signatures compliant with FDA 21 CFR Part 11?

Yes. Review and approval workflows capture attributable, time-stamped electronic signatures with signature manifests, and every change carries a reason, an effective date, and an immutable audit trail. The same controls support AS9100, ISO 9001, and IATF 16949 document-control requirements.

How does read-and-understand acknowledgment work?

When a procedure is revised, Cortrova routes it to the roles affected by the change and records each person's acknowledgment against that specific rev. The result is a live trained-to-rev roster, so you can prove who has and has not been trained on the current procedure without maintaining a separate spreadsheet.

Can controlled documents include drawings, CAD files, and ITAR-marked content?

Yes. Drawings, CAD attachments, manuals, and forms are all version-controlled alongside text documents. Export-controlled and ITAR content can be marked and access-scoped by permission, and the entire library can run on-premises or air-gapped for environments where data cannot leave the facility.

What happens to a document change that affects quality or production records?

Document control shares one data model with Quality and Production. A CAPA or nonconformance that requires a procedure change drives the revision through the same review-and-sign workflow, and linked work instructions, inspection plans, and travelers are surfaced so every downstream reference is updated to the new rev.

Get started

See Documents / DMS on your shop floor.

We'll tailor a demo to your operation and constraints.

Request a demo Explore the platform