Monitoring logs, sanitation and pre-op inspections, corrective actions and verification sign-offs, recorded as the work happens, signed and dated, and impossible to quietly change before the audit.
People who only need to look, such as managers, auditors and customers, get free viewer seats.
Screens show sample data from a fictional company.
Qualsted gives you the technical controls and the records; your procedures, training and verification of your own configuration complete the picture.
| Clause | How Qualsted helps |
|---|---|
| 21 CFR 117.145 | Monitoring. Monitoring records made at the time, with who recorded them and when, set by the server. |
| 21 CFR 117.150 | Corrective actions. Out-of-limit results flagged, with the corrective action and product disposition recorded and approved. |
| 21 CFR 117.155, 117.165 | Verification and record review. Records reviewed and signed by a qualified person, with reminders so reviews happen on time. |
| 21 CFR 117.35 | Sanitary operations. Pre-operational inspections of each area, with failed items corrected and re-inspected before production starts. |
| 21 CFR 117.305 | Records. Records kept with the actual values, date, time and the signature or initials of the person, and retrievable for the inspector. |
| SQF · BRCGS | Certification audits. Every record's history ready for the auditor, with read-only viewer access you can share. |
Working processes with review signatures, reminders and views set up, as ordinary tables and pages you can change.
Monitor critical control points, signed and dated when they're made, with a corrective action opened whenever a limit isn't met and daily verification.
21 CFR 117 Subpart C · 21 CFR 120 · Codex HACCP · SQF · BRCGS
Pre-operational inspections of each area before production starts, signed and dated when they're made, with a corrective action opened whenever an area fails and re-inspection before release.
21 CFR 117.35 · 21 CFR 117.80 · SQF · BRCGS
Approved suppliers with their risk, certificates and qualification, approved by Quality and requalified every year.
FDA QMSR (21 CFR 820) · ISO 9001 §8.4 · ISO 13485 §7.4 · AS9100 §8.4 · EU GMP Ch. 5
Who was trained on what, when, and by whom, with trainee and trainer sign-off and reminders when training falls due.
21 CFR 211.25 · FDA QMSR (21 CFR 820) · ISO 9001 §7.2 · ISO 13485 §6.2 · ISO/IEC 17025 §6.2
Customer complaints from receipt to closure: investigation, reportability decision, response, and QA approval.
21 CFR 211.198 · FDA QMSR (21 CFR 820) · ISO 13485 §8.2.2 · ISO 9001 §9.1.2
The assistant answers questions about your tables, draws charts and summarizes long records. It sees only what you can see, never changes or signs anything, and every use is logged.
Were any critical limits missed last week?
Chart pre-op inspection failures by area this month.
Answers come from the records you can see, with charts and links to them.
Records kept under FSMA's preventive controls rule are exempt from Part 11 (21 CFR 117.305(g)). Auditors still expect records that are signed, dated and can't be changed unnoticed, which is what Qualsted gives you anyway.
Yes, in the browser on a tablet or computer at the line. Areas and equipment can carry QR labels that open the right record when scanned.
