What the standard is

21 CFR Part 11 is the US FDA rule that decides when an electronic record can legally replace a paper one. It applies to any regulated company that keeps temperature data on a computer or a cloud platform instead of in a logbook.

The rule asks for four things. Records must be protected so nobody can silently change a reading. Every action must be tied to a named user through a login. Every change must be captured in a time stamped audit trail that cannot be deleted. And the system itself must be validated, which means you document that it works the way you say it works.

One point is often missed. Part 11 applies to the software that holds the record, not just the sensor that takes it. A logger on its own does not make you compliant. The platform behind it does.

Which of our equipment meets it

• Cobalt X1 and Cobalt X2 wireless data loggers, when used with the OCEAView platform. OCEAView is developed to 21 CFR Part 11 requirements and records every reading, alarm, user action, acknowledgment and system event.
• Cobalt Xs and Cobalt Xs WiFi, on the same OCEAView platform.
• Emerald and Atlas Bluetooth data loggers, whether they run standalone or as wireless sensors feeding the Cobalt X.
• Tempmate GS2 and Tempmate GM2, through the tempmate Cloud, which supports GxP workflows with tamper evident records and audit ready reporting aligned to Part 11 and EU GMP Annex 11 expectations.

Alarm acknowledgment on the Cobalt X touchscreen needs a PIN code, so even an action taken at the fridge door is attributable to a person. That is the level of detail Part 11 is written for.

What the standard is

EN 12830:2018 is the European standard that defines what a temperature recorder must do before it can be called one. It covers devices working anywhere between minus 80 degrees Celsius and plus 85 degrees Celsius, which takes in everything from ultra low freezers to ambient shipments.

It sets the accuracy the device must hold, the test methods used to prove it, and where the sensor has to sit for transport, storage and distribution use. It also sets rules for the record itself. Data has to be protected from manipulation, it has to carry an audit trail, and it has to stay accessible and readable for the required retention period.

Importantly, the standard applies to the whole recording system, not just the probe. The sensor, the recorder and the report are all in scope.

Which of our equipment meets it

• Tempmate GS2 single use 4G shipment logger. Conformity: EN 12830, CE, RoHS, RTCA DO-160, MSDS, EMC, FCC.
• Tempmate GM2 rechargeable multi use 4G logger. Conformity: EN 12830, CE, RoHS, RTCA DO-160, MSDS.
• Tempmate S2 single use logger with display. Conformity: EN 12830, CE, RoHS, RTCA DO-160, MSDS.
• Tempmate M1 and Tempmate M2 multi use loggers with display. Conformity: EN 12830, CE, RoHS, RTCA DO-160, MSDS.
• Degrite S, our own USB temperature data logger, designed in Germany and manufactured in India. EN 12830 compliant and GDP compliant, supplied with a traceable calibration certificate.
• The OCEAView platform used with Cobalt X, Cobalt Xs, Emerald and Atlas meets EN NF 12830 alongside its other compliance commitments.

What the standard is

EN 13486 is the companion standard to EN 12830. EN 12830 proves the device was accurate when it was built. EN 13486 covers what happens after that.

Every sensor drifts. A probe that read correctly two years ago may be half a degree out today, and half a degree is the difference between a passed batch and a rejected one. EN 13486 sets out how recorders and thermometers are verified at regular intervals so that drift is caught and corrected.

This is why a calibration certificate has an expiry date, and why auditors ask for the current one rather than the original.

Which of our equipment meets it

This one is about service, not just hardware. Lisaline Asia runs an in house ISO 17025, NABL accredited calibration facility, and offers both in lab and on site calibration for temperature, humidity and CO2 sensors.

Periodic verification is available across the range, including Cobalt X1, Cobalt X2, Cobalt Xs, Cobalt Xs WiFi, Emerald, Atlas, the Tempmate shipment and storage loggers and Degrite S.

For the Cobalt range, Dickson's Smart Sensor technology stores calibration data inside the sensor itself. You swap the sensor for a freshly calibrated one and the logger picks up the new calibration automatically. No downtime on the monitoring point.

What the standard is

ISO/IEC 17025 is the international standard for calibration laboratories. It does not certify a product. It certifies the lab that checks the product.

A lab accredited to ISO 17025 has proved its technical competence, its measurement uncertainty, its reference standards and its traceability chain. In practice it means the certificate you hand to an auditor carries weight, because the number on it can be traced back to a national measurement standard.

In India this accreditation is granted by NABL. In the United States it is A2LA and NIST traceability. In France it is COFRAC.

Which of our equipment meets it

• Cobalt X1, Cobalt X2 and Cobalt Xs offer ISO/IEC 17025 accredited calibration, certified non accredited calibration, or NIST traceable calibration.
• Emerald and Atlas offer ISO/IEC 17025 accredited calibration through the Dickson laboratory, plus certified and NIST traceable options.
• Tempmate GS2 and GM2 carry a validation certificate available as a PDF through the tempmate Cloud.
• Tempmate S2, M1 and M2 ship with a 6 point validation certificate, supplied both as a hard copy and as a PDF held in device memory.
• Degrite S ships with a traceable calibration certificate from the manufacturer.

On top of this, Lisaline Asia's own ISO 17025 NABL accredited lab recalibrates devices from every brand we supply, on site or in lab, so your compliance documentation stays current after the first year.

What the standard is

WHO PQS E006 is the World Health Organization's prequalification category for temperature monitoring devices used in immunisation programmes. A product does not simply claim to meet it. It is independently type tested against a published performance specification and a verification protocol, then listed by WHO with its own PQS code and a validity date.

For government immunisation supply, UNICEF supply and Gavi funded procurement, a PQS listing is usually not optional. If the device is not on the list, it cannot be bought.

E006 covers vaccine vial monitors, freeze indicators, threshold indicators and electronic thermometers used at every level of the vaccine cold chain.

Which of our equipment meets it

Temperature indicators from Temptime, a Zebra Technologies company:

The VVM number tells you the vaccine profile the monitor is matched to. A VVM30 reaches its end point after 30 days at 37 degrees Celsius. A VVM250 takes 250 days at the same temperature. The stability of the vaccine decides which one is applied.

There is a detail here worth knowing. The independent verification work behind several of these PQS listings was carried out in India by Lisaline Lifescience Technologies. We do not only supply PQS listed devices. We are one of the labs that tests them and submits the reports to WHO.

What the standard is

WHO PQS E004 is the prequalification category for passive insulated containers. These are non powered boxes that hold temperature using ice packs, gel packs or other phase change material rather than a compressor.

The specification measures one thing above all others. Cold life. That is the time from the moment the lid closes until the warmest point inside the vaccine compartment first reaches plus 10 degrees Celsius, measured at a constant ambient temperature of plus 43 degrees Celsius. The testing protocol also covers drop tests, vibration tests, coolant pack robustness and the requirement that the storage compartment never falls below zero degrees Celsius.

The 43 degree test condition matters for Indian buyers. It is written for hot zone climates, which is exactly what a May afternoon in most of the country looks like.

Which of our equipment is built to it

• Hemokool Passive Cooling Boxes, our thermal carry bags, are built on the same cold life principle. They hold plus 2 to plus 8 degrees Celsius for more than 12 to 16 hours at an ambient temperature of plus 30 degrees Celsius, using KOOLGEL frozen packs inside PE foam insulation with a removable PVC liner. Available in multiple sizes, including the 4 litre model 7001 and the 8 litre model 1215 with a temperature display.
• Hemokool Active Cooling Boxes solve the same last mile problem with power. Single and dual chamber options, AC and DC operation with battery backup, refrigerant based temperature control, an LCD display and internal LED lighting.

Where a programme requires a PQS listed container specifically, talk to our team. Lisaline Asia carries out PQS validation and box testing in house, so we can tell you exactly where a product stands before you commit to a tender.

What the standard is

Good Distribution Practice governs everything that happens to a medicine after it leaves the factory and before it reaches the patient. The two reference documents are the EU GDP Guidelines 2013/C 343/01 and WHO Good Distribution Practices, TRS 957 Annex 5.

GDP asks distributors to qualify their storage areas through temperature mapping, monitor conditions continuously with calibrated equipment, keep the records available for inspection, and investigate every excursion rather than quietly writing off the stock.

The word calibrated is doing a lot of work in that sentence. Under GDP, an uncalibrated sensor produces a record that is worth nothing.

Which of our equipment meets it

Every logger we supply is built for GDP reporting.

• Degrite S, Tempmate S2 and Tempmate GS2 for single use, one way shipments, all EN 12830 and GDP compliant.
• Tempmate M1, Tempmate M2 and Tempmate GM2 for multi use and return leg shipments.
• Cobalt X1, Cobalt X2, Cobalt Xs, Cobalt Xs WiFi, Emerald and Atlas for storage areas, cold rooms, refrigerators and warehouses, with OCEAView meeting GxP, GMP, GDP, HACCP and FSMA expectations.

We support the rest of the GDP picture too. Thermal mapping of cold rooms, labs and warehouses using certified protocols. Installation with IQ and OQ validation. Calibration certificates and device validation reports that you can put straight in front of an inspector.

What the standards are

ISO 9001 is the general quality management system standard. It tells you the manufacturer has documented processes, controls its suppliers, handles non conformances properly and improves on a cycle rather than on a whim.

ISO 13485 is the stricter medical device version. It adds device specific requirements around design controls, risk management, traceability of every batch and post market surveillance.

For a temperature indicator this matters more than it first appears. The indicator is a chemical product. Two labels from two different batches have to respond at exactly the same temperature, or the visual proof means nothing.

Which of our equipment meets it

• HEATmarker VVM, HEATmarker VVM+ and FREEZEmarker indicators are manufactured under Temptime's quality system, listed with WHO as ISO 13485 and ISO 9001:2015.
• Temptime's quality management system is also consistent with FDA Quality System Requirements under 21 CFR Part 820, the GMP rule for medical devices.
• LIMITmarker and Safe-T-Vue indicators come from the same Temptime manufacturing quality system.
• Tempmate devices are built under an integrated quality management system certified to ISO 9001 and audited annually.

Each box of Safe-T-Vue indicators also carries QA documentation for that specific lot, with the lot number and expiry date printed on the box.

What the standards are

Blood has its own rulebook, and it is tighter than the one for pharmaceuticals.

The AABB Standards for Blood Banks and Transfusion Services set the accepted practice for handling blood at every step from collection to transfusion. 21 CFR 600.15 sets the temperature limits during shipment of biological products, and 21 CFR 640 adds the specific standards for human blood and blood components.

The practical requirement is this. Red blood cells in transit must stay between plus 1 and plus 10 degrees Celsius. If a unit crosses 10 degrees, it cannot go back into inventory. The whole question is whether you can tell which units crossed the line and which did not.

In India the same ground is covered by the National Blood Transfusion Council and NACO guidelines, with blood products regulated by CDSCO under the Drugs and Cosmetics Act.

Which of our equipment meets it

• Safe-T-Vue 10 is the blood bag temperature indicator built specifically against these standards. It sticks directly to the bag and turns from white to red permanently once 10 degrees Celsius is reached or crossed. Accuracy is plus or minus 0.4 degrees Celsius. It stays viable for 42 days after application, which is the full life of a red cell unit.
• Safe-T-Vue 6 covers the same job at a 6 degree Celsius indication temperature.

Because the change is irreversible, a unit that was warmed and then put back in the fridge still shows red. That is the entire point. A thermometer on the shelf tells you the temperature now. Safe-T-Vue tells you what happened to that individual bag while nobody was watching.

For the transport leg itself, pair the indicators with Hemokool Passive Cooling Boxes and a Degrite S or Tempmate logger to hold the record for the full journey.

What they cover

Not every product fails from cumulative heat. Some fail the moment they cross a line once.

LIMITmarker is a single use heat threshold indicator. It works on heat fusible materials that melt at a set temperature, turning the window from white to red or pink. Variants respond after a delay of about 2 hours, quickly in about 15 minutes, or almost immediately, depending on how sensitive the product is.

FREEZEmarker covers the opposite failure. Freezing damages many vaccines and biologics permanently, and unlike heat damage it often happens inside the cold chain rather than outside it, when a fridge runs too cold or an unconditioned ice pack sits against a vial.

FREEZEmarker response temperatures are 0, minus 1 and minus 6 degrees Celsius, with accuracy of plus or minus 1 degree Celsius and a response time within 30 minutes. The green circle with the white tick turns opaque white once a freeze event happens, and it does not turn back.

Which of our equipment meets it

• LIMITmarker for heat threshold events on individual units.
• FREEZEmarker for freeze events, with FREEZEmarker L carrying WHO PQS prequalification under code E006-067.
• Both are available on TransTracker backing cards for placement inside secondary packaging and shipping cartons, not only on the product itself.

What they cover

CE marking is the manufacturer's declaration that a product meets the applicable EU health, safety and environmental requirements. For electronic monitoring devices this brings in the EMC Directive for electromagnetic compatibility and the Radio Equipment Directive for anything transmitting over Bluetooth, WiFi, LoRaWAN or cellular.

RoHS restricts hazardous substances such as lead, mercury and cadmium in electrical equipment. It matters at disposal, and for single use loggers that get discarded in volume it matters a lot.

Which of our equipment meets it

• Tempmate GS2, GM2, S2, M1 and M2 are all CE marked and RoHS compliant. The GS2 additionally carries EMC and FCC conformity for its 4G radio.
• HEATmarker VVM, HEATmarker VVM+ and FREEZEmarker L are CE marked, as recorded on their WHO PQS listings.

What the standard is

RTCA DO-160 is the environmental test standard for equipment carried on aircraft. It covers temperature and altitude, vibration, humidity, shock, and electromagnetic interference with aircraft systems.

If your shipment flies, and most pharmaceutical exports do, the logger inside the box is airborne equipment. Airlines and freight forwarders will ask about it, especially for devices that transmit.

Which of our equipment meets it

• Tempmate GS2, GM2, S2, M1 and M2 all carry RTCA DO-160 conformity.
• The GS2 and GM2 add automatic flight detection. The device recognises that it is airborne and stops transmitting, then resumes once it lands. Airline approvals are available on request.

Lithium and non lithium battery versions of the GS2 are both available, which matters when a carrier or a destination restricts lithium cells in air cargo.

What the standard is

IEC 60529 defines the IP code, the two digit rating that tells you how well an enclosure keeps out dust and water. The first digit is solids. The second is liquids.

IP65 means fully dust tight and protected against low pressure water jets from any direction. IP67 means dust tight and able to survive temporary immersion in water.

In an Indian cold chain this is not a detail. Condensation forms every time a box moves from a cold room to a loading bay in July. Monsoon transit means water on the outside of the carton. A logger that fails from moisture takes the record with it.

Which of our equipment meets it

The S2 TH sits at IP52 because a humidity sensor needs air exchange to read at all. That is a design trade off, not a weakness.

What applies here

International standards set the bar for the device. Indian regulation decides whether your facility passes inspection.

The revised Schedule M of the Drugs and Cosmetics Rules, 1945, notified in December 2023 and phased in from 2024, brings Indian GMP much closer to WHO GMP and PIC/S. It adds explicit expectations around computerised systems, data integrity, quality risk management and lifecycle validation. In plain terms, manual temperature logbooks are no longer a comfortable answer during a CDSCO inspection.

For vaccines moving through the government immunisation programme, WHO PQS listing and the eVIN system govern the equipment and the reporting. For blood, the National Blood Transfusion Council and NACO guidelines apply alongside CDSCO licensing.

For calibration, NABL accreditation to ISO/IEC 17025 is what Indian inspectors recognise. A certificate from an unaccredited lab will be questioned.

How we support it

Lisaline Asia holds an in house ISO 17025, NABL accredited calibration facility, offering calibration both in lab and on site across India. We handle installation and commissioning with IQ and OQ validation, thermal mapping of cold rooms, labs and warehouses, WHO PQS validation and box testing, annual maintenance contracts and 24x7 online support.

Every device comes through an official supply route with proper labelling, manufacturer support and the compliance documentation to match.