Protect every discovery

21 CFR Part 11 expects electronic records used to demonstrate compliance to be secure, attributable and protected from undetected change. Section 11.10(e) requires the “use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records,” and adds that “record changes shall not obscure previously recorded information.” Eltek’s Darca Command software stores continuous, time-stamped, non-editable temperature and humidity records with exactly this kind of audit trail, supporting laboratories and pharma cold-chain teams working towards 21 CFR Part 11, EU GMP Annex 11 and GxP requirements. No monitoring product makes a facility “compliant” on its own; validation and process remain the organisation’s responsibility, and Eltek’s system supplies the controls and evidence that support it.

ULT freezer validation means mapping under a realistic, worst-case load rather than an empty chamber, capturing door-open events (the biggest driver of excursions), and validating the alarm strategy itself, thresholds, escalation delays and out-of-hours delivery, not just the mapping report. Eltek GENII loggers support dense sensor placement without excessive cabling for true spatial profiling, and bridge one-off mapping with continuous 24/7 monitoring in the same ecosystem.

EU GMP Annex 11 (Computerised Systems), part of EudraLex Volume 4, sets out how computerised systems used in GMP environments should be controlled. On audit trails it states that “consideration should be given, based on a risk assessment, to building into the system the creation of a record of all GMP-relevant changes and deletions (a system generated ‘audit trail’).” Eltek’s Darca Command records continuous, time-stamped temperature and humidity data with a secure audit trail, giving quality teams the GMP-relevant history Annex 11 anticipates. Validation of the system in its intended use remains the organisation’s responsibility.

The WHO model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products (WHO Technical Report Series, No. 961, Annex 9) and the EU Guidelines on Good Distribution Practice (2013/C 343/01) both expect storage areas to be temperature-mapped before use and then monitored continuously with calibrated equipment and alarms. Eltek maps cold rooms, fridges and cold chains, monitors them 24/7 with UKAS-traceable calibrated sensors, and escalates any out-of-tolerance excursion by SMS and email before it costs you stock.

No monitoring product makes a facility compliant on its own, and any supplier who claims otherwise should be treated with caution. 21 CFR Part 11 compliance depends on your validation, procedures and controls as well as the technology. What Eltek provides are the underlying controls the regulation asks for: secure, computer-generated, time-stamped, non-editable records with full audit trails, role-based access and scheduled reporting. Eltek supplies the evidence and controls that support your compliance; validation and process remain yours.

A single undetected excursion, often triggered by a door left open or a failing compressor, can compromise samples that have no second copy. Eltek monitors ULT freezers, fridges and cold rooms continuously rather than by spot checks, holds high and low alarm thresholds aligned to your SOPs, and escalates a breach to the right person by SMS and email, with time-delayed alerts to cut nuisance alarms. Every reading is stored as a time-stamped, audit-trailed record, so you can both respond in the moment and evidence what happened afterwards.

Life sciences monitoring is the continuous measurement of temperature, humidity and related parameters in environments where sample integrity and regulatory compliance are critical. It covers ultra-low temperature freezers and cold rooms, pharmaceutical cold chain, IVF and embryology incubators, stability chambers, cleanrooms and biobank storage. Eltek delivers wired and wireless monitoring with UKAS-traceable calibration, audit-ready records and alarms, supporting laboratories and healthcare facilities working to GxP, ISO and 21 CFR Part 11 requirements.

The best cold chain monitoring system monitors every fridge, freezer and cold room continuously with calibrated sensors, alarms an out-of-tolerance excursion before stock is lost, and keeps secure, time-stamped records for audit. Eltek maps storage before use, monitors it 24/7 with UKAS-traceable calibrated sensors, and escalates breaches by SMS and email, meeting the expectations of EU GDP and WHO cold-chain guidance.

Both work, and many labs mix them. Wireless GenII transmitters are quick to deploy across freezers, fridges and incubators without cabling, while wired probes suit fixed, high-accuracy points such as ULT freezers and stability chambers. Eltek runs both on one connected platform with UKAS-traceable calibration, continuous logging and alarms that escalate an excursion before samples are affected.