One flagship workflow: the Regulatory Change Integrity Review.
ClinicOps reconciles one approved change against every regulated record that should reflect it — EUDAMED, UDI data, certificates, SS(C)P, declarations, labels, IFUs, controlled documents — and returns a source-linked exception queue with an owner and closure evidence per row. You bring the exports and controlled records you already have. Nothing to implement; your RIM, QMS, PLM and ERP stay where they are.
The Regulatory Change Integrity Review
What goes in
One approved change; the records, registers, documents and language versions your team expects to reflect it; a fixed evidence window; a named regulatory owner.
What comes out
A closure packet: source register, change-surface matrix, comparison result per surface, mismatch and missing-evidence findings, a named owner for anything unresolved, and closure evidence. Every row carries Source · Expected · Observed · Status · Evidence · Owner · Next Action · Closure.
How it runs
Establish the authoritative source → identify declared downstream surfaces → normalise identifiers and versions → collect available evidence → compare deterministically → identify mismatches, missing evidence and ownership ambiguity → route unresolved interpretation to your qualified reviewers → produce the closure queue → capture closure evidence.
Why this shape
Regulatory teams already carry a heavy administrative load across siloed systems. The review takes the comparison work off them without asking anyone to migrate anything.
Most exceptions are documentary and close without clinical input. Where one needs clinical context, ClinicOps can bring in independent specialist review — medicine and nursing — and record it in the evidence trail. How specialist review works →
Scope a change integrity review
Starting from a portfolio instead of a change
No single change on the table yet? The same review can start from a portfolio export: CSV/XLSX/JSON, RIM or UDI exports, product master data, document registers, public EUDAMED evidence where available. The Portfolio Integrity Scan is that scope of the review, not a separate product. It returns missing fields, conflicting values, missing evidence, record relationships and an owner/action queue, as a readable report plus a machine-readable export. It is usually the first engagement.
When changes keep coming
Continuous Portfolio Integrity Monitoring is the recurring extension of the same review — scheduled evidence checks, record-drift detection and a standing exception queue. It is offered only after a completed review has shown that drift recurs; ClinicOps does not sell monitoring ahead of demonstrated need.
Where does your problem live?
EUDAMED and UDI data, SS(C)P operations, Class III / implantable MDR transition, authorised-representative portfolios, document control and multilingual version integrity are all this one workflow — each has its own page under use cases. Denmark market access and Danish pharmacovigilance support have their own page.