Evidence first. Compliance second.

Evidence you canstand behind.

Evidentra helps medical-device quality teams find, verify, map, and package audit evidence from the systems they already use.

See how it works The evidence layer

The problem is not always missing evidence.

It is evidence that is hard to find, verify, and explain.

When an audit request arrives, the work often becomes a search across QMS repositories, SharePoint, Microsoft 365, spreadsheets, email, and temporary folders.

Make the trail clear before the pressure arrives.

A clearer path through the record

From scattered records to a reviewable package.

One evidence layer across the systems your team already trusts. No replacement QMS. No black-box conclusion.

Connect the sources

Bring in authorized records from SharePoint, PDF, Excel, and the systems your team already uses.

Map the evidence

See where each record came from, what it supports, and how it relates to FDA QMSR or ISO 13485 requirements.

Review the package

Inspect recommendations, resolve potential gaps, and prepare a traceable package for the next request.

QMS evidence libraryRead-only sync

RecordSourceStateVersion

Supplier corrective action reviewSharePointMapped2024-04-18

Training effectiveness recordQMS exportReview2024-04-12

Design history file indexPDF uploadGap2024-04-03

Illustrative product previewReview stays visible

Organized folders and source records arranged on a desk

Source records / version 01 / evidence library

Organized, not abstracted away

Keep the source visible.

Every recommendation should lead back to a record, a timestamp, a control mapping, or a human decision. Evidentra is designed to make that trail easier to inspect.

Evidence organized. Proven. Ready.

Human in control

The recommendation is inspectable. The decision remains yours.

AI can help surface a potential gap or aging record. It should not claim that a customer is compliant, guarantee an audit outcome, or replace the judgment of a quality professional.

01See why a record was suggested.

02Review the mapping before it moves forward.

03Record the decision for the next person.

A quality professional reviewing a layered audit package

Human review / final judgment stays visible

The evidence layer

Every finding comes with a trail.

Find

Surface relevant records across the repositories already in use.

Verify

Keep source, timestamp, version, and permissions visible in the trail.

Map

Relate evidence to controls without turning a recommendation into a verdict.

Package

Prepare a reviewable handoff for an auditor, regulator, or internal team.

For the next evidence request

See the evidence, then decide.

A focused first step toward practical audit readiness, without surrendering the final call.

See how it works