For clinical operations, quality, and research teams: SOPs, approvals, training, and evidence in one system — with a trail regulators and inspectors accept.
Conflicting versions circulate; nobody is sure which procedure is current on the floor.
Sign-offs exist somewhere in threads — unprovable at inspection time.
Read-and-understood records get assembled by hand before every audit.
Each site adapts its own copies until ‘the standard’ is several standards.
· 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 |
|---|---|---|---|
| Draft raised | Quality author | New revision linked to the prior version | Draft created & versioned |
| Clinical review | Department reviewer | Review comments on the record | Review recorded |
| Committee approval | Quality committee | Approval on a defined route, per signer | Sign-off bound to identity & time |
| Effective release | Quality lead | Prior revision superseded, not deleted | Effective version locked |
| Floor access | Clinical staff | Read of the effective revision only | Access enforced by role |
| Audit export | Compliance | Ordered history: draft → approval → effective | Evidence package exported |
Versioned, classified, access-controlled records with review cycles, effective dates, and read-and-confirm training tracked inside the system.
Review and approval on defined paths — quality review, department sign-off, escalation on SLA — every decision bound to a person and a timestamp.
CAPAs, change requests, audits, and committee actions with explicit owners, due dates, and leadership visibility across departments and sites.
Owner drafts v1.4 against the controlled v1.3.
Quality reviews with comments on the record.
Department head signs; identity and time bound.
New version effective; read-and-confirm assigned.
Captured with evidence attached, owner assigned.
Findings and root cause documented in Vault.
Corrective action routed and signed in Flow.
Closed with a complete, sealed history.
Items linked to the controlled documents.
Each member’s review on the record.
Outcome bound to the members and the time.
Decision and basis preserved, exportable.
Every step above is owned, timed, and sealed to the record — these are the workflows we model with you in week one.
Any SOP’s full history — versions, approvals, training — exports as one package.
The floor sees only the effective revision; superseded copies retire automatically.
Who read what, when — tracked as it happens, not reconstructed.
From detection to CAPA closure, sealed in order.
One standard, local ownership, no silent drift.
Overdue reviews, open CAPAs, and training gaps in one view.
Run these in your evaluation — they’re the moments where governed and “governed” differ.
Confirm the floor can only reach the effective revision — and that v1.2 is preserved, not deleted.
Try to make a document effective without quality sign-off. The system should refuse.
One SOP: versions, approvals, training — exported in minutes, in order.
Assign read-and-confirm; watch coverage update live, per person.
From detection to CAPA closure — every step attributed and timed.
It’s built for quality-managed work — enforced routes, immutable trails, controlled documents — and we support your validation activities with documentation and a stable release process. Validation itself remains yours; we’ll walk your quality team through exactly what we provide.
Yes — implementation includes structured import: documents come in with owners, classifications, and versions, not as a dump. Week 2 of the pilot plan.
Cloud by default, with regional residency, private cloud, and dedicated tenancy for clinical deployments.
We’ll model your real SOP lifecycle in the first week — and you’ll see the trail your inspectors will.