Each revision stays on file with its reviewers, approvers and dates, and every change is in the audit trail, so which revision was in force on any date is read from the record at the audit, not reconstructed the week before.
Quality ManagementControl the full
Control the full
document lifecycle
Write, review, approve and distribute policies, SOPs and work instructions, with every revision kept, every approval recorded and the training reassigned on the effective date.
Every revision is kept, with who approved it and when
A revised SOP goes effective on the date you set, signed in the document
Retraining goes out the day the revision goes effective
Platform connections
Compliance Frameworks
When a procedure changes, Qualio reassesses the clauses it answers and puts a recommendation on any gap.
CAPAs and change controls
Each links to the documents it affects, so you can see why a revision was made.
Confluence and SharePoint
Qualio reads the policies and work instructions your teams already keep there, as they are, and assesses and links them without moving them.
Frequently Asked Questions
What is document control?
Document control is the procedure that runs the lifecycle of a company's quality manual, policies, SOPs, work instructions and forms, from draft to approval to withdrawal, so everyone works from the current revision and obsolete ones leave use. ISO 13485, ISO 9001, cGMP and EU GMP all require it, and an auditor checks that the procedure is followed as well as written.
Does Qualio support 21 CFR Part 11?
Yes. Approvals are signed electronically with the signer's name, the date and time and the meaning of the signature on the record, and every change to a document is kept in the audit trail.
What is the difference between document control and document management?
Document management usually means storing and organising files. Document control adds the rules a regulated company needs: who can write, review and approve a document, which version is current and what changed. Qualio is built for document control, so each revision is approved, distributed and traceable.
What should document control software include?
Document control software should manage the whole lifecycle. That means review with comments and tracked changes, approval with electronic signatures, controlled distribution, automatic version history and an audit trail of every change. Qualio does each of these, and assigns retraining when a revision takes effect.
How do you make sure staff are retrained when an SOP changes?
Link training to the controlled document, so that when a revision takes effect the people it affects are assigned retraining. In Qualio, retraining goes out to everyone affected on the effective date the approver sets.
Can AI edit a controlled document without approval?
No. In Qualio, Copilot reviews or updates a controlled document on request, cites its source for every output and waits for your approval before anything enters the document.
Which procedure is out for review right now?
Bring it to the demo and we will walk the same revision through review, approval, the effective date and the retraining in Qualio.