Testing and calibration labs keep requests, samples, methods, results, reports, equipment and competence records that assessors trace end to end. Build them in one workspace, with changes recorded to the person and time and reports approved before they go out.
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 |
|---|---|
| §7.1 | Review of requests, tenders and contracts. Each request reviewed for capability and method before work starts, with who reviewed it and when. |
| §7.4 | Handling of test or calibration items. Samples identified with unique IDs and QR labels, with condition on receipt and storage location. |
| §7.5, §8.4 | Technical records and control of records. Original observations and results, with every change tracked to the person and time and the original value kept. |
| §7.8 | Reporting of results. Reports with results, reviewed and authorized by a signature before release. |
| §6.4, §6.5 | Equipment and metrological traceability. An equipment register with calibration records and reminders two weeks before calibration falls due. |
| §7.10, §8.7 | Nonconforming work and corrective action. Nonconforming work recorded, evaluated and linked to corrective action. |
Working processes with review signatures, reminders and views set up, as ordinary tables and pages you can change.
Customer test requests reviewed before work starts, and test reports authorized by a signature before they're released, linked to each other, with reminders before a report is due.
ISO/IEC 17025 §7.1 · ISO/IEC 17025 §7.8 · ISO/IEC 17025 §7.5
Receive samples with unique IDs and storage locations, record test results against specifications (pass or fail is calculated), and have them reviewed.
ISO/IEC 17025 §7.4 · §7.5 · §7.8 · 21 CFR 211.194 · GLP (21 CFR 58)
An equipment register with calibration records reviewed by Quality, and reminders two weeks before calibration falls due.
21 CFR 211.68 · FDA QMSR (21 CFR 820) · ISO 9001 §7.1.5 · ISO/IEC 17025 §6.4 · ISO 13485 §7.6
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
Product or material that doesn't meet requirements: identify it, decide its disposition, and get it approved.
ISO 9001 §8.7 · ISO 13485 §8.3 · FDA QMSR (21 CFR 820) · AS9100 §8.7 · IATF 16949 §8.7
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.
How many test requests are waiting for review?
Chart results by method and outcome this month.
Answers come from the records you can see, with charts and links to them.
Not directly. Results are entered or imported from CSV and Excel files, checked row by row. If you need instruments writing results automatically, a LIMS with instrument integration is a better fit.
Give a customer a free viewer seat and share only their folder or table: they see their records on screen, nothing else.
