Quality & Compliance · For manufacturers

Vedashwa Pramana

Evidence-first audit-readiness. It maps your evidence to the standards, scores how ready you are, and shows the clause and the proof behind every statement.

11 standards liveBuilt on Cortex
Book a demo
Vedashwa Pramana readiness dashboard — readiness by framework (ISO 13485, 21 CFR 820, EU MDR, ISO 14971) and by domain, upcoming activities, and evidence by status

How it works

Evidence in, readiness out — always explainable, always human-reviewed.

1

Ingest evidence

Reads your records and documents wherever they live — including read-only from your QMS.

2

Map to requirements

Suggests which evidence proves each clause; a human confirms every link.

3

Score readiness

Full / partial / missing / stale per requirement → a readiness %, version-aware.

4

Surface gaps

Each gap becomes a finding with clause provenance and a plain-language narrative.

5

Remediate

Draft a corrective-action plan or SOP — AI-drafted, human-approved, never auto-written.

6

Assemble the binder

Export an audit-readiness evidence binder (PDF / Markdown), plus a traceability graph.

11 standards, cross-mapped

Evidence you attach for one standard’s clause shows up against the equivalent clause in every other — map once, cover many.

ISO 13485ISO 1497121 CFR 820EU MDRUK MDRIndia MDR21 CFR Part 211ICH Q10ICH Q7ICH Q9GxP Data Integrity (ALCOA+)

Readiness, not compliance

Every score says how ready you are (“78% of expected evidence present & current”), never “78% compliant.”

Read-only & human-approved

Pramana never writes back to your systems. Drafts become records only when a human approves them in the system of record.

Traceable & version-aware

Every finding cites the exact clause and the files reviewed; superseded evidence is flagged stale, and a traceability graph walks it end to end.

Vedashwa Pramana assesses audit readiness and surfaces gaps for human review. It does not determine, certify, or guarantee regulatory compliance.

Know your gaps before the auditor does