Laboratory Equipment Compliance Services

Open the door to sample integrity and confident compliance

Selecting the right compliance services solution is a significant part of your quality system. As you rely on quality results from our extensive range of equipment, including everything from centrifuges and pipettes to cold storage and water purification systems, you also can trust Unity Lab Services to be the compliance partner that helps you meet your regulatory assurance and documentation needs.

We provide compliance services for:

  • Centrifuges
  • Cold storage equipment
  • Incubators
  • Shakers
  • Remote monitoring sensors

Our compliance and calibration services support organizations that rely heavily on equipment for critical sample storage and growth, and our protocols reflect a customized approach aimed at delivering robust and efficient regulatory compliance coupled with the desired degree of confidence.

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Service benefits

  • Industry-exclusive “No-Charge Re-qualification Guarantee”: We are the only OEM to offer a guarantee and promise to re-qualify the unit at no charge if a key component fails while under the original product warranty or while equipment is under a support contract. Coupled with our global reach and local support, Unity Lab Services is better positioned to offer consistent and comprehensive support compared to smaller, local, third-party service providers.
  • OEM confidence: We’re trained in validation and equipment maintenance, so we fix audit issues others can’t.
  •  Proven efficiency: We help you pass qualifications the first time with our one-and-done best practices, which ultimately save resources and maintain operational uptime.
  • Audit-ready calibration: Our services comply with ISO/IEC 17025 standards, giving you confidence that your calibration results will be both precise and accurate.

Lab equipment compliance services

  • Installation Qualification (IQ): Documented verification that equipment is installed to manufacturers’ recommendations and/or user requirements.
  • Operation Qualification (OQ): Documented verification that equipment (as installed) is operating as intended to manufacturer’s specifications.
  • Performance Qualification (PQ): Documented verification that equipment can perform effectively and reproducibly based on approved specifications.
  • Calibration: Periodic verification that equipment is producing accurate results within specified limits compared to traceable standards of measurement; best suited for cold storage equipment, CO2 incubators, centrifuges, water purification, and pipettes.
  • Preventive Maintenance (PM): A standard set of procedures intended to ensure equipment performance is at or near the same levels achieved at the time of installation.
  • Temperature Mapping (TM): Provides data measured at different temperatures and locations, door opening recovery tests, backup system testing, and a variety of checkpoints; best suited for cold storage and incubation equipment.

 

Recommended services for your regulatory needs:

Application Requirement Recommended Services
Initial qualification for new equipment or change of service/status I need my equipment qualified before I can use it IQ/OQ/PQ bundle
Re-qualification I need annual or periodic qualification

PM

TM

Calibration

Fleet programs
I have multiple units and I need service done throughout the year

PM

TM

Calibration

IQ/OQ

OQ/PQ

Turn to the industry leader

Contact us today to take advantage of our industry-exclusive “No-Charge Requalification Guarantee.” If a key component fails while under the original product warranty or while equipment is under a support contract, we will re-qualify the unit at no charge.

Coupled with our global reach and local support, Unity Lab Services is better positioned to offer consistent and comprehensive support compared to smaller, third-party service providers.

Recommended compliance services across the equipment life cycle

Unity Lab Services offers flexible compliance services that fit an organization’s unique needs. Regular maintenance plus frequent qualification, calibration, and preventive maintenance are recommended to lengthen equipment life and mitigate risks of non-compliance.

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