Compliance that keeps up with the work.
OPRA Flow is one platform for requirements, documents, and quality events — where doing the work and proving it happened are the same action. No side spreadsheets. No pre-audit fire drills.
Quality doesn’t break in the audit. It breaks in the workarounds.
Nobody means for it to end up this way — but every workaround is a place where the record and reality quietly drift apart.
The work scatters, the record decays
- Requirements in one tool, risks in a spreadsheet
- Training records somewhere in a shared drive
- A CAPA living in someone’s inbox
- The traceability matrix rebuilt by hand before every audit
The work and the record are the same thing
- One connected record set across requirements, documents, and quality events
- Approvals signed where the work happens — not over email
- Traceability that’s live, not reconstructed
- Nothing to remember to update, so nothing quietly drifts
OPRA Flow puts the work and the record in the same place — so the easiest way to work is also the compliant one.
Three modules live today. One system underneath.
Start with the module that hurts most. Add the others when you’re ready — everything writes to the same records, so there’s never a migration.
OPRA Start
From user needs to product requirements with the traceability matrix generated live — linked, versioned, and audit-ready from day one, never reconstructed the week before an inspection.
OPRA Docs
Controlled documents with e-signature approvals, change control that routes itself, and training records tied to the exact version people were trained on.
OPRA Events
CAPAs, non-conformances, deviations, and incidents in one engine — root cause to verification of effectiveness, with KPIs calculated as you go, not tallied each quarter.
Every record traces back to a user need. Automatically.
Requirements, documents, and quality events all hang off one connected record set. Change a user need upstream and everything it touches downstream is flagged for review — no spreadsheet archaeology, no stale matrix.
Nothing is ever overwritten
Every change closes the old version and opens a new, cross-referenced one.
Add modules without migration
New modules read and write the records you already have.
Traceability is a live view
Not a document someone maintains.
One upstream edit. Every affected record flagged, downstream, automatically.
Not just a tool for the Quality team.
Everyone who touches a device programme gets a workspace in their own language — because a system people route around isn’t a quality system.
The founder
See the whole path to market without becoming a regulatory expert first.
The quality & regulatory lead
Walk into any audit with traceability that’s already live.
The engineer
Compliance falls out of shipping. It isn’t a second job.
Leadership
Real compliance posture across every product — not a slide assembled the night before the board meeting.
Built like the regulated product it manages.
Every module inherits the same foundations — so security and auditability aren’t features you configure, they’re the floor.
Your data is encrypted, backed up, and never used to train AI models. No one at AYB Solutions has access to customer data.
ISO 27001 and SOC 2 certifications are in progress — ask us for current status.
Request our security pack →Tenant isolation
Every customer’s data is walled off at the database layer, enforced on every query.
Immutable audit trail
Every change logged with who, what, and when. Exportable.
Part 11 e-signatures
Compliant signing built into every approval flow.
Encrypted & backed up
GDPR-compliant hosting. Your data stays yours.