Calibration · Metrology · Instrument management
Calibration schedules, records and due dates in one place.
Each instrument keeps its schedule, certificates and history.
Every Instrument Tracked
Schedules, certificates and as-found/as-left history in one place.
Overdue Shown Clearly
Due and overdue devices are visible to the people who use them.
Station use you control
Where you configure it, out-of-calibration devices are kept off kiosk tasks.
What goes wrong today3 common problems
Calibration Spreadsheets Miss Due Dates
An overdue instrument on the line is a 483 finding — and a potential lot rejection for everything it measured since the last cert.
As-Found Readings Get Lost
Without the as-found reading, you can't run the back-stop investigation to confirm prior lots were in spec.
Lab Certificates Live in Someone's Email
When the auditor asks for the latest ISO 17025 cert for the master weight set, nobody can find it.
Everything V5 does here5 capabilities
Every Instrument, Scheduled and Tracked
Asset register with calibration frequency, tolerance, accuracy class, location, owner and next-due date. Notifications fire at 30, 14 and 1 day.
As-Found / as-Left Capture
Calibration form captures both readings, calculates pass/fail against tolerance, and triggers an OOT investigation when as-found is out of tolerance.
Production lockout when overdue
An overdue instrument can't be selected on a kiosk — production is blocked until calibration is current. No more retroactive 'we used it anyway' findings.
ISO 17025 Certificates Linked to Each Cal
Upload the lab cert, link to the standard used, retain through the asset's life.
Back-stop investigation when OOT
An out-of-tolerance result automatically lists every batch the instrument touched since the last good calibration, and routes them for QA review.
How it works, step by step5 steps
Calibration lifecycle in V5.
- Instruments loaded. Range, tolerance, interval, lab, standard captured.
- Work orders emitted. Reminders and pre-due escalation.
- As-found / as-left captured. Signed record with cert attached.
- Kiosk Gating. Overdue instrument blocked at the step.
- Failed Cal Impact Assessment. Batches back to last good cal surfaced.
What to look for when choosing
Calibration systems must lock the floor when instruments drift out of period. Reminders alone are a paper program.
Kiosk Lockout on Due
Does the kiosk refuse steps that require a specific instrument when that instrument is overdue? Instrument state evaluated at the step; overdue = blocked.
As-Found / as-Left History
Are both captures required and trended? Both required; drift trended per instrument.
ISO 17025 Lab Reference
Do external calibrations carry the accredited lab, cert number and traceability chain? Lab, cert, standard and uncertainty captured; chain browsable.
Auto-Scheduling and Workflow
Do due dates drive work-orders and reminders with escalation? Native scheduler; pre-due reminders; escalation to metrology lead.
Retro Impact on Failed Cal
When a failed cal is discovered, does the system surface every batch that used the instrument since the last successful cal?
V5 Compared with Other Approaches
Calibration in V5 vs spreadsheet vs standalone CMMS module.
| capability | spreadsheet | legacy Qms | v5 |
|---|---|---|---|
| Kiosk lockout on due | None | Rare | Native |
| As-found trending | Manual | Optional | Native |
| ISO 17025 chain | Paper | Attach PDF | Structured |
| Batch traceback on failed cal | Manual | Report |
Regulations this supportsYour quality team stays responsible for compliance
Calibration clauses and V5's answer.
21 CFR 211.68(a)
Program per instrument with due-driven work orders.
21 CFR 820.72(a)
Suitability tests documented; failed cal surfaces batch impact.
ISO/IEC 17025
Accredited-lab references, cert numbers and traceability captured per calibration event.
EU GMP Annex 15 §3.41
Interval, tolerance and lockout enforced by the platform.
Standards Referenced
- 21 CFR 211.68 (Automatic, mechanical and electronic equipment)
- 21 CFR 211.160(b)(4) (Calibration of instruments)
- 21 CFR 820.72 (Inspection, measuring and test equipment)
- ISO 9001:2015 §7.1.5 (Monitoring and measuring resources)
- ISO/IEC 17025 (Testing and calibration laboratories)
- EU GMP Annex 15 §3.41 (Calibration)
Common questions4 answers
- Does V5 lock out overdue instruments?
- Yes. Operators can't select an overdue instrument on a kiosk — the step is blocked until calibration is current and signed off.
- What happens when an as-found reading is out of tolerance?
- V5 automatically opens an OOT investigation, lists every batch the instrument touched since the last good calibration, and routes those batches for QA review — the back-stop check FDA expects.
- Can we hold ISO 17025 lab certificates in V5?
- Yes. Each calibration record links to the lab cert, the standard used and the chain back to a national standard, retained for the life of the asset.
- How fast can we deploy?
- Standard calibration onboarding is 7–10 days including asset import from your existing spreadsheet or CMMS.