For engineering, quality, and operations teams: current work instructions where the work happens, change control that’s provable, and supplier files that stay current.
Printed or copied work instructions outlive their revisions.
ECRs decided in rooms and email — hard to trace later.
Nonconformances tracked in files that miss the audit.
Certs and qualifications lapse without anyone noticing.
· Product recreation based on live NILARA workflows.
Every step has an owner, a record, and a seal — so the evidence package assembles itself.
| Step | Owner | What’s recorded | Sealed |
|---|---|---|---|
| Issue logged | Line / QA | Nonconformance linked to the SOP | Record created |
| Investigation | Quality engineer | Root-cause & actions on the record | Steps recorded |
| Approval | Quality manager | Sign-off on a defined route | Bound to identity & time |
| SOP update | Document owner | New revision; prior superseded | Effective version locked |
| Supplier action | Procurement | Supplier approval / corrective action | Action recorded |
| Audit readiness | Quality lead | Ordered CAPA history | Evidence package exported |
Revision-controlled work instructions and drawings with controlled distribution and watermarked copies; supplier certs with expiry tracking.
Engineering change approval across functions, nonconformance disposition, supplier qualification — with SLAs and escalation.
Change requests, maintenance actions, and quality tasks with owners, due dates, and cross-functional visibility.
Change scoped with affected items.
Engineering, quality, and ops review.
Signed by each required function.
New revision live; training assigned.
Captured with evidence, owner assigned.
Use-as-is / rework / scrap decided by rule.
Corrective action routed and tracked.
Complete history preserved.
Certs and audits into the record.
Quality reviews against requirements.
Supplier status signed.
Expiries tracked; renewal routed automatically.
Every step above is owned, timed, and sealed to the record — these are the workflows we model with you in week one.
Superseded instructions retire automatically.
Every ECR from request to effect, in order.
NCs and CAPAs with complete sealed histories.
Expiry tracking with routed renewals.
Evidence accumulates as work happens.
Open changes, NCs, and overdue reviews in one view.
Run these in your evaluation — they’re the moments where governed and “governed” differ.
Confirm operators can only reach the effective work instruction.
ECR to effective revision — with every function’s sign-off in order.
Use-as-is / rework / scrap routed by rule, sealed at close.
Verify the renewal routes itself before the lapse.
One change, end to end — in minutes.
Yes — read-optimized access to effective instructions, on shared terminals or tablets, with confirmation tracking.
Vault governs the record — revisions, approvals, distribution — with large-file handling and references to your PDM/PLM where one exists.
External roles let suppliers submit certs and acknowledge requirements without entering your internal workspace.
We’ll model your ECR path end to end — and show the trail your customer auditor asks for.