Compliance
Built to pass the audit
ProcessView+ gives regulated labs the technical controls that 21 CFR Part 11 and AMS 2750 require — audit trail, electronic signatures, encrypted records, role-based access, and automatic TUS reporting — without bolting on extra tools or consultants.
For pharma, medical & clinical
21 CFR Part 11 electronic records & signatures
Part 11 is the FDA's rule for trustworthy electronic records. ProcessView+ supplies the controls inspectors look for, in plain terms:
Audit trail
A complete, time-stamped, computer-generated record of every action — who changed what, when, and why. The trail is preserved alongside the data and cannot be quietly edited, so reviewers and inspectors see the full history.
Electronic signatures
Each signer authenticates with their own signing PIN. The signature is cryptographically bound to the exact record signed and records the signer, the meaning of the signing, and a UTC timestamp in the tamper-evident audit trail — the equivalent of a handwritten signature on paper records.
Encrypted, protected records
Data files are encrypted and tamper-evident, so records stay accurate and attributable from creation through retention. You keep the original electronic records — there are no exports to a third-party host.
Role-based access
Five built-in roles — operator, technician, supervisor, QA reviewer, and administrator — limit who can run, edit, sign, and administer. Access controls keep responsibilities separated, a core expectation of any Part 11 system.
Every signature states its meaning
Signers choose from a defined set, so the audit trail records why each record was signed:
The formal Part 11 compliance statement is documented for the Watlow® F4T, whose front panel is locked so every change is routed through ProcessView+ and recorded in the audit trail. The software also runs Watlow F4, EZ-Zone PM, and Future Design® MCT4 controllers.
21 CFR Part 11 Compliance Statement
A detailed walkthrough of how each Part 11 requirement maps to a ProcessView+ feature.
For aerospace & defense QC
AMS 2750 thermal uniformity & Nadcap
AMS 2750 governs pyrometry for heat-treat operations. ProcessView+ turns your logged data into the surveys and records a Nadcap audit demands:
AMS 2750 TUS reports
Generate thermal uniformity survey (TUS) reports automatically from logged sensor data, with the layout and statistics heat-treat auditors expect — no manual spreadsheet work.
Calibration & SAT records
Keep calibration and system accuracy test records organized and retrievable, tied to the chambers and instruments they cover.
Nadcap-ready documentation
Full chamber qualification documentation, retained and exportable, so you walk into a Nadcap audit with the evidence already assembled.
A note on validation
ProcessView+ provides the technical controls — audit trail, electronic signatures, encrypted records, access control, and reporting — that support a 21 CFR Part 11 or AMS 2750 compliant process. Demonstrating compliance also depends on your own procedures, validation, and documentation in your environment. We're glad to support your validation effort; for formal regulatory or legal sign-off, consult your quality and regulatory professionals.
Need to prove it to an auditor?
See exactly how ProcessView+ produces the records and reports your audit requires.