For the Quality Manager
Make audit readiness a standing state, not a fire drill.
You know the drill: three weeks before the auditor arrives, the whole department stops to chase signatures, hunt revisions, and close CAPAs that drifted. Cortrova runs SPC, nonconformances, CAPA, and controlled documents on one live data model with a 100% audit trail, so the evidence exists because the work happened in the system - not because someone assembled it afterward.
The challenge
- !Audit prep is a three-week fire drill: chasing signatures, reconciling the NCR log against the CAPA tracker, and praying the revision on the floor matches the revision in the binder
- !SPC happens after the fact, if at all - by the time the control chart is plotted, the out-of-control run already made a lot of scrap
- !CAPAs open with good intentions and drift: no due-date discipline, no effectiveness check, and the same root cause resurfaces six months later
- !Document control is a race you keep losing: a superseded work instruction survives at a workstation because pulling paper from the floor never quite finishes
How Cortrova answers
- ✓Nonconformances, dispositions, CAPA, and effectiveness verification run as one linked workflow with AS9100-mapped steps, so nothing closes without the record an auditor will ask for
- ✓SPC runs live against inspection data as it's recorded, flagging an out-of-control condition during the run - while the operator can still adjust - not at the end-of-week chart review
- ✓Controlled documents carry revision, approval, and distribution in the system: the work instruction at the station is the current revision because there is no other copy to find
- ✓Every change to every record carries who, what, and when - 100% audit coverage of mutations, including AI actions - so the audit trail is a byproduct of the work, not a project
- ✓Unlimited users puts every inspector, operator, and supervisor in the system, so inspection results, holds, and dispositions are captured at the point of work instead of transcribed from travelers
A day on the platform
Quality management when the evidence writes itself.
The standard doesn't get easier. What gets easier is proving you meet it, because the objective evidence accumulates as the work happens instead of being reconstructed before the audit.
Morning - the quality state of the plant
Open NCRs by age and disposition, CAPAs against due date, SPC flags from overnight runs, and any shipment sitting on a quality hold - one screen, current now, no log reconciliation.
An NCR that goes somewhere
An operator flags a nonconformance at the station. It lands in your queue with the work order, lot, operation, and inspection data already attached. Disposition, MRB if needed, and CAPA linkage happen on the same record.
CAPA with due-date discipline
Every corrective action carries an owner, a due date, and a required effectiveness check. Overdue actions escalate automatically, so the CAPA log stops being a place where problems go to age.
The auditor arrives on a Tuesday
Trace a lot from raw material receipt through inspection results, dispositions, and the certificate of conformance without leaving the system. The audit is a walkthrough of records that already exist, not a scramble to create them.
How it works
Adopting For the Quality Manager.
Weeks 1-2: map your QMS
Discovery walks your quality manual, inspection points, disposition flows, and the standards you certify to. Workflows are configured to your procedures - AS9100-mapped where that's your world - so the system enforces what your manual already says.
Weeks 2-4: migrate the quality record
Open NCRs, active CAPAs, controlled document registers, and supplier quality history move into the system, so you go live with your quality state intact instead of a cold start that orphans open items.
Weeks 4-6: train every inspector
Unlimited users means the training phase covers everyone who touches quality - inspectors, operators recording results, supervisors dispositioning holds - not just the quality office. Data gets captured at the source from day one.
Weeks 6-8: validated go-live
Go-live validates that inspection plans fire at the right operations, holds block what they should, and the audit trail captures every change. Most manufacturers complete the full deployment in a typical 4-8 weeks.
FAQ
Questions, answered.
What does the audit trail actually capture?
Every mutation in the system - every record created, changed, or dispositioned - is logged with who, what, and when, and that includes actions taken by embedded AI agents, which pass through a seven-stage governance pipeline ending in an audit log. Coverage is 100% by architecture, with zero bypass paths. When an auditor asks who changed a disposition and when, the answer is a query, not an investigation.
Does Cortrova support FDA 21 CFR Part 11 and validated environments?
Cortrova supports FDA 21 CFR Part 11 requirements with electronic signatures, controlled records, and the full change audit trail, alongside AS9100-mapped workflows and support for ISO 9001:2015 and IATF 16949 quality management. Validation of your specific environment remains your process, and the deployment includes a validated go-live phase where the system is verified against your acceptance criteria.
How do my existing NCRs, CAPAs, and controlled documents get in?
Data migration is a dedicated phase of the five-phase implementation, and it's included in the flat annual rate. Open NCRs, active CAPAs, document registers, and supplier quality records move in before go-live, so open items keep their history and their due dates instead of restarting from zero.
Do my inspectors and operators each need a license?
No. Pricing is one flat annual rate with unlimited users and no per-seat licensing, so every inspector, operator, and supervisor works in the system. That matters more for quality than almost anyone: the record is only as good as the point of capture, and rationed seats are how inspection results end up transcribed from paper travelers at end of shift.
Get started
See Cortrova through the quality manager's screen.
We'll tailor a demo to your role, your KPIs, and your operation.