Understanding Calibration, Compliance and Validation Services

March 2022

It’s important businesses and lab operations keep their lab equipment calibrated, validated, and compliant to regulatory requirements and industry standards. But keeping lab equipment up to spec is no small task and requires expert consult.

Which is why Thermo Fisher Scientific’s compliance teams are available on-call to ensure customers’ labs are compliant with regulations and in accordance with their manufacturer’s specifications. Throughout the entire life cycle of ownership, Thermo Fisher Scientific are the trusted experts that design, build, test, and support a validation process that is tailored to the specific needs of every lab.

Thermo Fisher Scientific has more than 40 years of expertise developing validation plans to suit the needs of lab operations, large and small. Using state-of-the-art technology, our compliance teams work with customers directly to minimise the frustration and effort felts by lab practitioners who are charged with implementing compliance measures and controlling validation costs. 

Thermo Fisher Scientific’s calibration services are available through their NATA accredited laboratories across Australia or delivered straight to site by way of mobile calibration services that provides premium remote support. Non-NATA calibrations and PPE testing are performed to Australian Standards, and ASTEA asset management portal allows customers to track their assets calibration and compliance. 

Thermo Fisher Scientific has NATA (ISO17025) accreditations which extend to the field of electrical, pressure and temperature calibrations.

Chemical and gas

Thermo Fisher Scientific’s calibration laboratories can provide non-NATA calibrations in the field of chemical testing, and capable of calibrating toxic gas and chemical analysers, mine safety equipment and personal pumps.

Electrical

The NATA accredited electrical laboratory calibrates electrical instruments such as digital multimeters, clamp meters, portable appliance testers, RCD testers and all other essential handheld instruments – all calibrated to an accuracy of 10-20ppm for volts and 30-160ppm for resistance. 

Pressure

Purpose-built pressure management tools can calibrate pressure measurement and instruments such as pressure gauges and barometers that range from as low as -100 kpa up to 70,000 kpa. 

Temperature

Thermo Fisher Scientific’s heat and temperature labs allow for controlled and simulated temperature testing to an accuracy of 0.05 ºC. They can calibrate temperature probes and related instruments that range in temperature from -20ºC up to 650ºC.

Laboratory instruments and pipettes

Other specialisations include calibrating, maintaining and repairing water and liquid processing equipment and calibrating, repairing and servicing pipettes in compliance with IEC/ISO 17025:2017- POVA calibration from 0.2µL to 60mL, using NATA certified analytical balances, in accordance to ISO8655-6.

Weighing devices

Thermo Fisher Scientific also calibrates precision balance and weighing devices to NATA accreditation from microbalances that weigh 20µg up to 50kg to industrial scaled balances that weigh from 1mg up to 200kg. 

Mobile calibration vans 

All of these services and more are available via full-service Mobile Calibration Vans that travel directly to site in Queensland, New South Wales, and Victoria. 

These purpose-built Mobile Calibration Vans can calibrate all gas and chemical detectors on-site and perform non-NATA calibration of all other lab instruments– eliminating the need to transport delicate and expensive equipment for off-site maintenance. 

Qualification 

Thermo Fisher Scientific’s field service engineers (FSEs) are trained to perform instrument qualifications services that test, verify, and certify instruments using detail-oriented audit records that document an instrument’s performance and compliance history.

Given that Thermo Fisher Scientific design and manufacturers Applied Biosystems, Invitrogen, and Ion Torrent instruments, the FSEs are particularly well versed in their requirements and can ensure qualification at the point of installation.

Qualification services include:

• Installation qualification (IQ) — Provides documented evidence and verification that the instrument has been delivered and installed according to manufacturer’s specifications.

• Operational Qualification (OQ) — Provides documented verification that the instrument subsystems are operating as designed. Verifies that the functionality of an instrument meets the manufacturer’s operational specifications.

• Performance Qualification or Instrument Performance Verification (PQ or IPV) — Provides documented verification that the instrument system can perform effectively and reproducibly within performance specifications. Helps ensure confidence in results by verifying that the accuracy and precision of an instrument is maintained.

• Re-qualifications (OQ or OQ/PQ or OQ/IPV) — Provides documented verification that the instrument continues to operate as specified by the manufacturer. Typically performed annually after an initial IQ, OQ, PQ, or IPV has been completed, or according to user’s SOP requirements.

Software and system validation: 

Thermo Fisher Scientific’s Computer System Validation Service are a team of certified technical experts who assist customers in meeting global regulations such as GxP, CLIA, and ISO, by validating and documenting a system’s defined requirements in accordance with industry standards and best practices. 

This means ensuring electronic record-keeping systems are up to spec, accurate, and reliable by performing a full system audit. 

For full-service package options for calibration, compliance, and validation services, Thermo Fisher Scientific has thought of every risk and developed a suitable validation process– from point of purchase to scientific discovery, and beyond.

To consult with one of our representatives, contact the compliance team today.