Compliance scanner

Be inspection-ready before the inspector books a flight.

Run your PSMF, SOPs, and quality documents through published rule sets. Get a readiness score with each finding cited, evidenced, and paired with a remediation action.

What gets scanned

PSMF vs GVP Module II

~15 rules covering QPPV identity, deputy arrangements, organisational structure, safety database, SOPs, change log, subcontracting, SDEA listing.

SOP structure review

Purpose, scope, responsibilities, procedure, references, revision history, approvals. Flags missing sections + out-of-date reviews.

21 CFR Part 11 readiness

Electronic records + signatures. Scope of records, audit trail coverage, e-sig agreement on file, account controls.

Bring your own rule set if you have one. Praxara supports custom rule packs — we'll help you author them during onboarding.

How findings look

Every finding is actionable. No black-box "score".

criticalGVP Module II Section B.1
QPPV deputy or backup not documented
Evidence: Searched for 'deputy', 'back-up', 'backup', 'alternate QPPV' — no match found.
Recommendation: Add QPPV deputy name, contact, and handover arrangements to PSMF Section 3.
majorSOP structure
Revision history missing last 2 years
Evidence: Last listed revision: 2023-11-14. SOPs require annual review per GVP.
Recommendation: Perform annual review and document in revision history.
closedGVP Module II Section B.1
QPPV identity disclosed
Evidence: Qualified Person for Pharmacovigilance: Dr Jane Smith, [email protected], +44 20 7946 0000 (24/7).
Severity weighting

Critical x 3, major x 2, minor x 1. Readiness score = passed / (passed + failed x weight).

Evidence linked to source

Every finding cites the exact passage in the document. Click to jump to the page in the PDF viewer.

Signed-off register

Close each finding with a controlled-vocab reason + e-signature. Exportable CSV or PDF register for auditors.

See it against your own documents.

20-minute demo. Bring a redacted CSR, PSMF, or ICSR. We'll run it live end-to-end.