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OPRA Flow
One platform · every audit, ready
Secure Workspace Entry
One platform.Every audit, ready.
Sign in once for both engines — the quality OS (documents, change control, CAPA, training) and requirements traceability from user needs to IU/IFU.
Two engines · one sign-in
OPRA Flow · Quality OS
Documents, change control, CAPA and training — signed under 21 CFR Part 11.
OPRA Start · Traceability
User needs through URS, PRS and the IU/IFU — always in sync, one audit trail.
Built for compliance
ISO 13485
IEC 62366
21 CFR Part 11
EU MDR
UKCA