Pharma & life sciences · Computer system validation
For teams validating GxP software for regulated production use, Microfilm produces the test evidence a validation package is built from — attributable, time-stamped records signed by the tester who ran each one and traced to the requirement it verifies. It is the documented evidence computer system validation, guided by GAMP 5 and FDA’s CSA approach, is built on.
Validating software for regulated production use means standing behind the test evidence months later, in front of an auditor. Microfilm captures that testing as it happens and signs each record, so the evidence behind your validation is trustworthy by construction — not assembled from memory before the audit. It is the documented, traceable evidence computer system validation expects, guided by GAMP 5 and FDA’s risk-based Computer Software Assurance (CSA) approach.
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.
The pain
When test records are stitched together from memory, screenshots scattered across threads, and a spreadsheet edited the week before an audit, the question an FDA reviewer 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 it maps
Your testers run the validation work; Microfilm signs each step into an attributable, tamper-evident record as it happens — so the validation package is trustworthy by construction, not reconstructed for the reviewer.
Each test session records who ran it, against which requirement and test case, and what they observed — captured at the moment of work, not written up later.
Every verdict is signed and append-only, time-stamped at capture — the attributable, contemporaneous record a validation package needs to hold up at inspection, rather than one assembled after the fact.
A failed test routes to the tracker with the requirement, what was observed, and a link to the capture — so a defect is investigated against the evidence, not a vague report.
Requirement → test case → signed evidence stays linked; export the traceability matrix and the signed record behind every verdict without reopening sessions or rebuilding history.
Instead of a static audit package assembled at the end, share a scoped, read-only link to the live traceability matrix — every requirement mapped to the signed evidence that validates it — and let the auditor search and confirm it themselves. Each verdict reads in plain language — “Verified — signed by [tester], unaltered since capture” — not a raw signature to decode. Access is scoped to the audit and time-bounded, never a login to your whole evidence corpus. (Team plan and up.)
CSV / GAMP 5 ↔ Microfilm
Computer system validation — guided by GAMP 5 and FDA’s risk-based Computer Software Assurance (CSA) approach — turns on documented, traceable test evidence and data integrity. Microfilm doesn’t run your validation; it emits the evidence those expectations are built on, captured as the work happens.
Each requirement traced to the test that verifies it and the result, kept current through revalidation.
Live requirement → test case → signed evidence links, exportable or shareable as a live matrix.
Objective evidence that each test was executed and what was observed.
Each session captured against the requirement it exercises, with a signed verdict and the observed result.
Records that are attributable, legible, contemporaneous, original, and accurate — and stay that way.
An append-only evidence log: every record signed by who ran it and time-stamped at execution, nothing overwritten.
Assurance effort focused on what matters, with evidence captured as the work happens — not documentation for its own sake.
Evidence captured as a by-product of testing, so coverage gaps surface live instead of in a year-end binder.
FAQ
No. Microfilm produces the documented, traceable, signed test evidence a computer system validation relies on. The validation itself — your risk assessment, protocols, and acceptance — and any regulatory decision remain your responsibility; Microfilm gives you trustworthy evidence to build the package 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 attributable, contemporaneous record data integrity (ALCOA+) expects.
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.
Microfilm produces the documented, traceable test evidence a computer system validation relies on; it is not a validation service and does not validate your system for you. Your validation — the risk assessment, protocols, and acceptance — and any regulatory decision remain your responsibility.
Create a workspace for your team, or download the free capture app and record your first session.