Straight answers, by topic

Thermometers, temperature probes, data loggers and wireless temperature sensors. Our UKAS accreditation covers −90 °C to +135 °C for probes and sensors read with their own display or logger, and −35 °C to +40 °C for whole loggers and sensors, in our Tamworth lab or at your site.

We arrange calibration for every sensor we supply: traceable to national standards as standard, or UKAS accredited where you need it. Temperature sensors are calibrated in our own lab in Tamworth or at your site; for UKAS work it is our UKAS accredited calibration laboratory No. 10723, accredited to ISO/IEC 17025 for temperature for probes in a dry block from −90 °C to +135 °C, and for whole loggers and wireless sensors in an air chamber from −35 °C to +40 °C. Humidity, CO₂ and other parameters go to accredited partner laboratories. Each sensor has its own certificate.

Temperature: our own lab, traceable as standard or UKAS accredited in our UKAS accredited calibration laboratory No. 10723. Humidity, CO₂ and other parameters: an accredited partner laboratory, which issues its own certificate under its own UKAS accreditation number. We tell you which you'll get before we start. We carry out 10,000+ sensor calibrations a year.

Yes, through accredited partner laboratories. Our own UKAS accreditation covers temperature only; partner laboratories issue their own certificates under their own UKAS accreditation number.

No. Traceable calibration is our standard: it is traceable to national standards but not UKAS accredited. UKAS accredited calibration is there where you need it, for example for an ISO 15189 laboratory or where a customer or regulator asks for it. We tell you which you're getting before we start.

Yes. On-site calibration is inside our UKAS accreditation, where the site suits the work; we agree that with you first.

Yes, any make of temperature probe, logger or sensor within our scope.

The certificate states it. If your alarm limits ignore it, a reading near the limit could be out of range without the alarm going off. We can help you set limits that allow for it.

Due dates are tracked against each sensor and we contact you before they lapse.

In three parts. JTF qualifies the hardware at your site (IQ and OQ), Sematics validates the platform against its requirements and verifies each release according to its risk, and you qualify your configuration and use (URS, DQ and PQ) with our support, under a quality and technical agreement. See validation.

No. Sematics validates the platform and verifies each release according to its risk. You assess Sematics, approve your reliance on that evidence for the functions you use, and qualify what Sematics can't: your requirements, your configuration, notification to your people, your hardware and your procedures. You stay accountable for your use of the system, as Annex 11 expects.

Sematics validates the platform under a validation lifecycle aligned to EU GMP Annex 11, and gives you the evidence for your supplier assessment, applying the stricter July 2025 consultation draft where it asks more. Ask us for the current status of the validation documents under the quality and technical agreement. For each Annex 11 area, who is responsible and how Sematics approaches it, see Annex 11.

Design and configuration qualification. Your configuration is designed from your URS; the platform then exports the complete configuration, and DQ compares that baseline item by item with the URS. It replaces guesswork about how the system is set up with a record you can show.

No. Hardware is qualified separately: JTF carries out IQ and OQ of the sensors, gateways and probes at your site, with a calibration certificate for each sensor.

Each release is assessed and verified by Sematics according to its risk. Major releases are notified in advance with the release documentation and a configuration regression report run against your current configuration export. You assess each release under your change control and check the system after deployment.

Not usually. Routine changes (users, contacts, names) are recorded in the audit trail. Changes within the qualified design (a limit or delay within your URS bounds, another escalation tier) are made with a reason and approved as your procedure requires. Only a change to the design, such as a new site or limits outside your URS, goes through change control with the affected DQ and PQ tests.

An HQ addendum covers the history you carry over, alongside the usual URS, DQ and PQ. We plan the overlap so there's no gap in the record.

The guidelines don't use the word. They do require alarms that alert you to excursions from pre-defined storage conditions (3.3), which a manual check can't do overnight or at a weekend.

GDP asks for backups of computerised data to be kept for at least five years (3.3.1), and for distribution records to be kept for at least five years.

The guidelines ask for mapping under representative conditions; they don't ask for an accredited study. Calibration of the monitoring equipment must be traceable to national or international standards.

GDP is for wholesale distribution. Vaccine fridges in GP practices and pharmacies follow the Green Book, chapter 3, which our checklist also covers.

If it holds a wholesale dealer's authorisation, yes, and the MHRA will expect mapping, monitoring and calibration to GDP. See MHRA GDP.

The Green Book asks for readings recorded each working day. Keep the daily reading each working day, as the Green Book asks and CQC expects in GP practices; continuous monitoring adds the nights and weekends a manual check misses. Agree in writing which record is the original.

The alarm goes to the person you name, the readings show how long and how far it went, and the record holds what they did, ready for the cold chain report to UKHSA or the manufacturer. See temperature excursions.

Usually: how limits were set, what happens when an alarm goes off out of hours, who acted, and whether the sensors are calibrated with traceable certificates. The ISO 15189 explainer goes through it clause by clause.

Not in every case. It accepts recording equipment with alarms or a documented system of manual checks. Auditors and retail customers increasingly expect continuous records, and a manual check can't catch an overnight failure.

The CQC asks for daily records and action when readings are out of range. Continuous monitoring keeps that record for you and catches the nights and weekends a daily check misses.

The person on shift gets the alarm, the readings show how far and how long, and the record holds what they did and the advice they took. See temperature excursions.