AI GxP validation for regulated life sciences
Cybroscape eQMS · SOPs and controlled documents

Controlled documents that change when the process changes.

Write, review, approve and make effective SOPs, work instructions and forms, with periodic review dates and revisions opened automatically by the change that requires them.

Cybroscape eQMS: Document Control
Linked recordsCause to action
Human reviewBefore anything is approved
In short

Document control in Cybroscape eQMS manages SOPs, work instructions and forms through draft, review, approval, effective and retired states with Part 11 signatures. When a deviation, CAPA or change control requires a procedure update, the revision opens automatically once that record is committed, so agreed changes do not get lost between systems.

The problem

The procedure that was meant to change

A common inspection finding is not a missing SOP but an SOP that was supposed to be updated after an investigation and never was. The CAPA says 'revise SOP-014'; the revision depends on someone remembering to start it.

Meanwhile the old version stays effective and people keep training on it.

How Cybroscape eQMS handles it

Revisions triggered by the record that needs them

On a deviation, CAPA or change control you name the documents that must change and why. Nothing happens yet. When the record is committed, the revision opens on its own and goes through the normal write, review and approve steps. A rejected change opens nothing.

If the document is already under revision, the request is attached to that revision rather than starting a second one.

Drafted redlines

Quality Copilot can draft the changed text from the approved change description, shown as a redline against the current version. The author edits it and the reviewers approve it as they would any other revision.

Deliverables

What you get

Every revision linked to the record that required it
No revision opened for a change that was rejected
Periodic reviews scheduled and tracked
Version history and signatures available for inspection
Summary

What Document Control delivers

Document Control is part of the Cybroscape eQMS platform — an AI-native, agentic quality management system built for regulated Life Sciences. See how it fits with Deviations and Investigations, CAPA Management, Change Control.

document control softwareSOP managementcontrolled documents GMPeQMS document control
  • Full lifecycle from draft to retirement
  • Revisions opened by the deviation, CAPA or change that needs them
  • Periodic review reminders
  • Part 11 signatures and version history
FAQ

Common questions

Prefer to talk first? Chat with us on WhatsApp or book a call with an expert.

Can we keep our existing SOP templates?

Yes. Your templates and numbering scheme are configured during set-up, and migrated documents keep their version history.

Who can approve a document?

The roles you define, with segregation enforced: an author cannot approve their own document, and approval requires a Part 11 signature with re-authentication.

See document control on your own data.

Bring a recent deviation or change. We show you how it runs end to end, from intake to closure.

  • We reply within one business day
  • We walk through your own records
  • You get a clear migration plan

Book a demo

Four fields. The right specialist replies within one business day.

Your details stay private. We never share them.