Solution · 21 CFR Part 11
Microfilm produces attributable, tamper-evident, time-stamped test records for FDA 21 CFR Part 11 software validation — signed by the tester who ran each one and traced to the requirement it verifies.
FDA 21 CFR Part 11 expects electronic records that are attributable, tamper-evident, and tied to the person who attested them. Microfilm captures QA testing as it happens and signs each record — so the evidence behind your software validation is trustworthy by construction, not assembled after the fact.
Availability · Capture and signing are free forever on the desktop app. The self-building traceability matrix and audit-package export are Team-and-up cloud features.
What Microfilm is · Microfilm is a desktop app and cloud service that records software QA testing as it happens and turns it into signed, tamper-evident, audit-ready evidence — readable by both human auditors and AI coding agents.
Microfilm is the tool you use to produce attributable, tamper-evident test records; it is not a Part 11 certification and does not validate your system for you. Software validation and your Part 11 controls remain your responsibility.
The problem
When test records are stitched together from memory, scattered screenshots, and a spreadsheet edited the week before an audit, the question an auditor asks is simple: how do you know this is what actually happened, and who attests to it? Evidence assembled after the fact is hard to attribute, easy to dispute, and slow to defend.
How Microfilm fits
Each test session records who ran it, against which requirement and test case, and what they observed — captured at the moment of work and tied to the person who attested it, not reconstructed later.
Evidence is signed and written to an append-only log. A record cannot be quietly edited after the fact, so the integrity an auditor expects of an electronic record holds up to scrutiny.
Requirements link to acceptance criteria, to test cases, to the signed evidence that verifies them — so you can show coverage requirement by requirement instead of pointing at a folder of screenshots.
When the auditor asks, export the traceability matrix plus the signed evidence behind every verdict — without reopening sessions or rebuilding history.
The evidence
A Part 11-oriented record in Microfilm is a signed, append-only artifact: the requirement and acceptance criteria, the test case executed, what the tester observed, the attestation that signed it, and the time it was captured. That is the substance an auditor wants behind a validation claim — attributable, tamper-evident, and traceable to a requirement.
FAQ
No. Microfilm is the tool you use to produce attributable, tamper-evident test records that support a Part 11 evidence posture. Compliance, software validation, and your Part 11 controls remain your responsibility — Microfilm gives you trustworthy evidence to build them on.
Evidence is signed and written to an append-only log at the moment of capture. A record can’t be quietly altered afterward, so its integrity holds up when an auditor asks how you know it reflects what actually happened.
Yes. Each record carries who ran the test and attested the result, the requirement and test case it covers, and when it was captured — the attribution Part 11 expects of an electronic record.
The requirements traceability matrix plus the signed evidence behind each verdict. The matrix and audit-package export are cloud capabilities on the Team plan and up; capture and signing are free on the desktop app.
Create a workspace for your team, or download the free capture app and record your first session.