Protect every batch, and prove the conditions behind it
Continuous, validated monitoring for the cleanrooms, cold rooms, stability chambers and cold-chain storage a GMP site runs on, with the tamper-evident, audit-ready records your quality team can put in front of a regulatory inspector.
Trusted in GxP laboratories, pharmaceutical cold chain and regulated storage across the UK.
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The problem
In GMP manufacturing, the record is part of the product
A GMP site is judged twice: on whether conditions stayed within their validated limits, and again on whether it can prove they did. Cleanrooms, cold rooms, stability chambers, QC laboratories and finished-goods storage each carry their own risk, and a single unrecorded excursion can become a batch deviation, a CAPA and an inspection finding. Manual rounds and standalone loggers leave gaps at exactly the moments that matter, out of hours, during a door-open event, or when one unit among dozens starts to drift. Eltek has monitored regulated environments for over 40 years, pairing continuous sensing with the tamper-evident, audit-trailed records that stand up to MHRA scrutiny. Get the full compliance picture on the Life Sciences compliance page.
How should a GMP pharmaceutical site monitor its manufacturing environment?
Pharmaceutical manufacturing under EU GMP depends on continuous environmental monitoring of cleanrooms, cold rooms, stability chambers and cold-chain storage, with calibrated sensors, alarms that escalate an excursion, and secure, time-stamped audit trails. Eltek supplies that evidence and the controls behind it; validation of the system in its intended use stays the manufacturer’s responsibility.
The challenge
What makes environmental monitoring in GMP manufacturing so demanding?
Many environments, one quality system
Cleanrooms, cold rooms, stability chambers, warehouses and the cold chain each have their own limits and their own failure modes, yet all of them have to roll up into one defensible record. A mix of standalone loggers, equipment alarms and manual records accumulated as a site expands is how gaps and mismatched time-stamps creep in, and how whole-facility visibility disappears at the moments that most demand it.
An excursion is a deviation
An out-of-limit event is never only an operational nuisance. It opens an investigation, a CAPA and a question over batch impact. The real cost is missing the moment it happened, or being unable to evidence when it started, how long it lasted and who was told.
Data integrity under inspection
MHRA data-integrity expectations, commonly summarised as ALCOA+, mean a reading has to be attributable, contemporaneous and protected from undetected change. Paper rounds and spreadsheets struggle to prove any of that, which is why they are the first thing an inspector probes.
A system you have to validate and control
A computerised monitoring system is itself in scope: it has to be validated for its intended use and kept under change control. That is far easier with configurable commercial software and a supplier who provides the calibration certificates and documentation your validation leans on.
The solution
How Eltek monitors a GMP manufacturing site
Four principles: continuous coverage of every regulated environment, alarms that escalate an excursion before it costs a batch, records built for data integrity, and calibration you can defend, all from one UK engineering team.
Cleanrooms, cold rooms and stability storage on one system
Wired PT probes and wireless GenII transmitters monitor temperature and humidity across cleanrooms, cold rooms, stability chambers, QC laboratories and finished-goods storage. Door and contact inputs can be incorporated alongside temperature probes to help establish whether an excursion coincided with an equipment access event or a door left open. Local buffering in the transmitters maintains continuous recording during a network interruption, and new monitoring points can be added as operations expand, all reporting into one platform.
Alarms that escalate before a batch is at risk
SMS450 turns a threshold breach into grouped SMS and email alerts that escalate through the response team, moving to the next contact if the first alert goes unacknowledged, so an excursion is caught while there is still time to act on it, including out of hours.
Records built for data integrity
Darca Command stores continuous, time-stamped, tamper-evident readings alongside alarm activity and acknowledgement history, with secure audit trails and role-based access. That combined record, the environmental data plus the response to it, is what a deviation investigation or quality review can draw on, and it meets the electronic-record controls MHRA data integrity and EU GMP Annex 11 anticipate.
Mapping and validation support
Temperature mapping of cold rooms, chambers and warehouses under a realistic load, with UKAS-traceable calibration certificates and mapping reports that support your IQ, OQ and PQ documentation.
One UK engineering team
Specification, calibration, mapping and support come from the same Eltek engineers who design and build the system in the UK, never a reseller or an overseas helpdesk.
Standards and guidance
Which standards apply to environmental monitoring in pharmaceutical manufacturing?
Pharmaceutical manufacturing in the UK is regulated under EU GMP, retained by the MHRA after Brexit. EU GMP Annex 11 (Computerised Systems), part of EudraLex Volume 4, sets out how the computerised systems that hold GMP data should be controlled, and 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’).” EU GMP Annex 15 (Qualification and Validation) frames the IQ, OQ and PQ lifecycle for equipment and facilities, and EU GMP Annex 1, revised in 2022, covers the manufacture of sterile products and the controlled environments that support it.
Running through all of it is the MHRA “GXP” Data Integrity Guidance and Definitions (March 2018), which expects the data behind a GxP decision to be complete, consistent and accurate across its whole lifecycle, the principles commonly summarised as ALCOA+. For environmental monitoring, that turns on how a reading is captured, kept and produced for review, not on the sensor alone.
Where finished product is stored and distributed, the EU Guidelines on Good Distribution Practice (2013/C 343/01), retained in UK law, expect storage areas to be temperature-mapped before use and then monitored continuously with calibrated equipment, which is why mapping and monitoring belong together rather than as two separate exercises. The full framework-by-framework picture, and where Eltek’s evidence fits, sits on the compliance page.
In practice, none of these frameworks is satisfied by a product. They place obligations on the manufacturer: to validate the system in its intended use, to control it, and to review the record. What a monitoring system can do is supply the underlying controls and the evidence, secure, time-stamped, audit-trailed data backed by traceable calibration, so that when an inspector asks what conditions a batch was made in, the answer is the record itself.
The platform
The Darca Suite
One connected suite, wired and wireless, for every regulated environment on a GMP site, from cleanroom to cold chain.
Darca Collect
Wired PT probes and wireless GenII transmitters monitor temperature and humidity across cleanrooms, cold rooms, stability chambers and finished-goods storage, calibrated against UKAS-traceable standards so every reading is defensible.
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Darca Connect
The SRV450 hub relays the network securely and SMS450 escalates an out-of-tolerance excursion by grouped SMS and email, including out of hours, before a batch is affected.
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Darca Command
Darca Command holds continuous, time-stamped, tamper-evident records with secure audit trails, role-based access and scheduled reporting, built for GxP, EU GMP Annex 11 and MHRA data-integrity expectations.
ExploreProven in regulated science
Four decades of monitoring the environments where a few degrees decide the outcome
Eltek has designed and built environmental monitoring in the UK since 1985, and today its systems run in GxP laboratories, pharmaceutical cold chain and ultra-low temperature biobank storage. As part of the Royston Instruments Group, wireless GenII sensors, the cloud-connected Darca Suite and Cyber Essentials certification give a quality team continuous, tamper-evident records and UKAS-traceable calibration: the controls and the evidence that support GMP compliance, without ever claiming to confer it.
- GxP / GMP
- EU GMP Annex 11
- MHRA data integrity
- UKAS-traceable calibration
Speak to an Eltek expert
Tell us about your site, the cleanrooms, cold rooms, chambers and stores you need to monitor and the frameworks you are inspected against, and our UK engineers will map the system and the evidence your quality team needs.
Related reading
Life Sciences compliance
MHRA data integrity, EU GMP Annex 11 and GAMP 5, and exactly what Eltek supplies versus what stays your responsibility.
Read moreFrom compliance mapping to audit trails
How temperature mapping and continuous audit-trailed monitoring fit together across a regulated facility.
Read moreThe Darca Suite
Collect, Connect and Command: the wired and wireless sensing, the hubs and alarms, and the audit-trailed software that ties a site together.
Read moreMore in Life Sciences
Cold Chain Monitoring
Cold rooms, refrigerators, freezers and GDP warehouses. Continuous monitoring, mapping before use and audit-ready records that prove the cold chain held.
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IVF & Fertility Clinics
Incubators, cryogenic storage and the embryology lab. Continuous monitoring and instant alarms for samples that can never be replaced.
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Biotechnology & Cell and Gene Therapy
Cell and gene therapy, ATMPs and biotech. Continuous monitoring of cryogenic storage, cleanrooms and process areas, with audit-ready data integrity.
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Clinical & Diagnostic Laboratories
NHS pathology, diagnostics and contract testing. Continuous monitoring of fridges, freezers and sample stores, with a record for UKAS and ISO 15189.
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Universities & Research
University biobanks, research estates and core facilities. Continuous monitoring of ULT freezers and cryogenic storage, with alarms and a record for research governance.
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Equipment we monitor
ULT freezers, refrigerators, incubators, stability chambers, cold rooms, cryogenic storage, cleanrooms and GDP warehouses. One compact answer per equipment type.
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Temperature monitoring guide
What temperature monitoring is, what to look for in a system, wired versus wireless, UK compliance, and how Eltek monitors continuously with alarms and audit-ready records.
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Humidity monitoring guide
What relative humidity monitoring is, why it matters, what to look for, wired versus wireless RH sensing, and how Eltek monitors humidity and temperature continuously with alarms and audit-ready records.
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Temperature mapping guide
What a mapping study proves, how to run one, sensor placement principles, duration, UK compliance expectations, and the calibrated equipment your results depend on.
ExploreData logger guide
What a data logger is, the wired and wireless types, what to look for, why calibration matters, and how Eltek’s loggers feed one connected platform with alarms and audit-ready records.
ExploreFrequently asked questions
What does EU GMP Annex 11 expect from a computerised monitoring system?
EU GMP Annex 11 (Computerised Systems), part of EudraLex Volume 4 and retained by the MHRA, sets out how computerised systems used in GMP environments should be controlled, covering risk management, validation, data and audit trails. 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.
How does continuous monitoring help when a temperature excursion happens?
A continuous system captures the excursion as it happens rather than at the next manual round, so the record shows when it started, how far conditions moved, how long they stayed there and when they recovered. SMS450 escalates the alarm by grouped SMS and email, including out of hours, so someone can act while there is still time. That same time-stamped record, alongside the alarm acknowledgement and escalation history showing who was notified and when, is what supports the deviation investigation and any CAPA afterwards, because it evidences the event and the response rather than relying on a recollection of either.
Can Eltek support temperature mapping and validation for GMP storage?
Yes. Eltek maps cold rooms, stability chambers and warehouses under a realistic, worst-case load rather than an empty chamber, capturing door-open events, and provides UKAS-traceable calibration certificates and mapping reports that support your IQ, OQ and PQ documentation. The same GenII loggers then bridge one-off mapping and continuous 24/7 monitoring in one ecosystem. Qualifying the system in its intended use remains your responsibility; Eltek supplies the calibrated evidence that supports it.
Do we need to worry about 21 CFR Part 11 in a UK GMP facility?
21 CFR Part 11 is a US FDA regulation. It is relevant to a UK organisation only where it has US market exposure, for example products destined for the US market or data supporting an FDA submission; for UK GMP the primary frameworks are EU GMP Annex 11 and the MHRA’s data-integrity guidance. Where Part 11 does apply, Eltek’s Darca Command provides the secure, computer-generated, time-stamped audit trails it expects. Configuration depends on system implementation and customer processes; Eltek supplies the evidence, the organisation owns validation.
Does Eltek monitoring make our manufacturing site compliant?
No monitoring product makes a facility compliant on its own, and any supplier who claims otherwise should be treated with caution. Compliance depends on your validation, your procedures and the controls around them as well as the technology. What Eltek provides are the underlying controls regulators ask for: secure, time-stamped, tamper-evident records with full audit trails, role-based access and scheduled reporting, backed by UKAS-traceable calibration. Eltek supplies the evidence and the controls that support your compliance; validation and process remain yours.