Equipment, calibration and maintenance
Every instrument with its calibration and maintenance history and next due date. The month ahead is on a calendar, and the owner is reminded before anything lapses.
Operations · equipment · suppliers · inspections
Equipment, suppliers and inspections, on a calendar everyone can see.
Keep the records that keep a site running: what was calibrated, maintained, inspected or approved, by whom, and what is due next. Owners are reminded before something lapses, and every entry is signed and dated when it is made.
What you run in it
The upkeep records an inspector asks to see.
Each one is an ordinary table with a page and reminders you can change. The starting templates give you a working process on day one.
Suppliers and qualifications
Approved suppliers with their qualification status, certificates and expiry dates, so you know who you may buy from, and when a certificate needs renewing.
Inspections and monitoring logs
Checklists on a page for rounds, cleaning, temperatures and checks, signed and dated when they're completed, with a corrective action started when a reading is out of limit.
Checks that can't be skipped quietly
A monitoring log that shows what's out of limit.
Record each reading against its limit. A reading outside the limit stands out, and a rule can open a corrective action so it doesn't depend on someone remembering.
- Checklists on a page, completed and signed in the system
- Limits on the record, with out-of-limit readings flagged
- Corrective actions linked to the reading that raised them
- An append-only audit trail beside every entry
Stock and materials
Lots, expiry dates and release, with the rest of your records.
Reagents, standards, raw materials and packaging are tracked by lot, with expiry reminders and Quality's signed release before anything is used. The same workspace holds the supplier it came from and the equipment it is used on.
How it supports your standard
The questions an inspector asks about upkeep, and what answers them.
Qualsted gives you the controls and the records; your procedures, training and validation of your own configuration complete the picture.
| Requirement | How Qualsted helps |
|---|---|
| ISO 9001 §7.1.5 · ISO/IEC 17025 §6.4 | Equipment and measuring resources. Calibration and maintenance history with due dates, owners and reminders. |
| ISO 9001 §8.4 · ISO 13485 §7.4 | Purchasing and supplier control. Approved suppliers, qualification status and certificates with expiry dates. |
| 21 CFR 11.10(e) | Audit trail. Who created, changed or signed a record and when, recorded by the server and impossible to edit. |
| 21 CFR 11.50 · 11.70 | Signatures linked to records. Each entry shows the signer, the time and its meaning, and stays attached to what it approved. |
Templates
Start from these, installed in one click.
Working processes with signatures, reminders and views set up, as ordinary tables and pages you can change.
Equipment and calibration
An equipment register with calibration records reviewed by Quality, and reminders two weeks before calibration falls due.
- Equipment 8 columns · IDs like EQ-0001
- Calibrations 9 columns · IDs like CAL-0001 · signed: Reviewed by
- Reminder: Calibration due in 14 days
- Reminder: Calibration overdue
21 CFR 211.68 · FDA QMSR (21 CFR 820) · ISO 9001 §7.1.5 · ISO/IEC 17025 §6.4 · ISO 13485 §7.6
Supplier qualification
Approved suppliers with their risk, certificates and qualification, approved by Quality and requalified every year.
- Suppliers 10 columns · IDs like SUP-0001 · signed: Approved by
- Reminder: Requalification due in 30 days
FDA QMSR (21 CFR 820) · ISO 9001 §8.4 · ISO 13485 §7.4 · AS9100 §8.4 · EU GMP Ch. 5
Inventory and lots
An item master, lots with expiry dates and storage locations, a Quality release before stock is used, a log of every receipt and use, and reminders before lots expire.
- Items 9 columns · IDs like ITM-0001
- Lots 14 columns · IDs like LOT-0001 · signed: Released by
- Stock movements 8 columns · IDs like MOV-0001
- Reminder: Lot expires in 30 days
- Reminder: Lot expired
21 CFR 211.80 · 211.84 · 211.122 · FDA QMSR (21 CFR 820) · ISO 13485 §7.4 · §7.5.5 · ISO/IEC 17025 §6.6
HACCP monitoring log
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.
- CCP monitoring 11 columns · IDs like MON-0001 · signed: Verified by
- Corrective actions 9 columns · IDs like CA-0001 · signed: Verified by
21 CFR 117 Subpart C · 21 CFR 120 · Codex HACCP · SQF · BRCGS
Sanitation and pre-op inspections
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.
- Pre-op inspections 10 columns · IDs like PRE-0001 · signed: Verified by
- Sanitation corrective actions 8 columns · IDs like SCA-0001 · signed: Verified by
21 CFR 117.35 · 21 CFR 117.80 · SQF · BRCGS
Questions
What operations teams ask.
Is this a maintenance management system?
It covers calibration and maintenance records, due dates and reminders for the equipment you must keep in control. It isn't a work-order system with spare-parts costing, and it isn't meant to replace one.
Can we bring in our equipment list?
Yes. Import equipment, suppliers and history from CSV or Excel files; large imports run in the background while people keep working.
Can people on the floor find a record quickly?
Print a QR label for each piece of equipment or lot and scan it with a phone camera or a handheld scanner to open its record. Read-only viewer seats are free.
Who gets reminded when something is due?
The owner you set on the record, ahead of the due date and again if it passes, with Quality told for the records you choose.
See it with your own equipment list