Biolytic Lab Performance, Inc.

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Monday, 30 Dec 2024

Biolytic Services

Instrument Hardware
Qualifications

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Instrument Services and Service Plans
End-To-End Oligo Synthesis Training
Instrument Hardware Qualification

With Biolytic Lab Performance, Inc's instrument hardware qualification services, you can be confident that your laboratory instruments are installed, operating, and performing to manufacturer's specifications.

Our comprehensive testing of your laboratory instruments using verified tests, certified tools, and developed standards will verify your instrument's performance, contribute to meeting regulatory requirements, and qualifying your instruments for operation in an GLP and GMP environment.

Types of Qualification Services

IQ

Installation Qualification

Provide full documentation with regards to all aspects of the instrument as built, the environment it is installed in, and the physical installation process.

OQ

Operational Qualification

Provides documented verification that the instrument is operating as designed.

Verifies that the functionality of an instrument meets manufacturer's operational specifications including testing, verification, and documentation of each function in the instrument.

PM

Preventative Maintenance

Preventative Maintenance procedures reduce unscheduled instrument downtime by proactively servicing the instrument.

Satisfies GLP / GMP requirements certifying the instrument is performing to factory specifications.

Procedures include inspections, testing, and calibration, and replacement of commonly worn parts.

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When are Qualification Services Recommended or Required?

Instruments should be regularly tested to confirm high quality performance consistent with manufacturer's specifications. Events requiring qualification testing:

  • At Installation
  • After a move
  • After additions, changes, or upgrades to the system
  • After a critical repair
  • For a scheduled OQ site requirement
  • Before a previously installed system will be used in a regulated environment

What is Included in the Qualification Services?

Testing

Comprehensive testing of instrument using verified tests, certified tools, and developed performance standards

Repair

Instrument will be repaired or maintained to reach manufacturer's specifications

Documentation

Documentation will be issued to be used as verification that your instrument is operating as it should be

Why choose Biolytic Lab Performance?

Experienced Technical Support

Biolytic is the Original Equipment Manufacturer (OEM) with over 25 years of experience in troubleshooting and repairing DNA RNA oligonucleotide synthesizers and laboratory accessories. Our experts provide a comprehensive documentation solution for guaranteeing peak performance from your laboratory instrument.

Efficient and Cost Effective

Our experienced field service engineers can quickly and efficiently test, maintain, and repair your laboratory instrument to manufacturer's specifications with minimal downtime so you can return to work with a qualified instrument faster.

Recommendations

Application

Requirement

Recommended Services

Initial qualifications for new instrument or change of service/status

I need my instrument qualified before I can use it

IQ / OQ

Operational qualification at scheduled Intervals

I need annual or periodic qualification

PM / OQ

Re-qualification following corrective maintenance or major change to instrument

I need my instrument qualified to ensure it still operates within OEM specifications after a repair or configuration change

PM / OQ

Frequently Asked Questions

Link to PDF Version

    Are you ISO 9001 Certified?
    We are not ISO 9001 certified however we follow standard best practices and are working towards ISO 9001 certification.

    Are you ISO 13485 Certified?
    We are not a medical device company and therefore not ISO 13485 certified.

    Is your software 21 CFR compliant?
    Our software is not 21CFR compliant, however it includes all the controls to be compliant. It is the customer's responsibility to validate their entire process to be considered 21 CFR compliant.

    Are you GMP Certified?
    We are not GMP certified. We offer IQ and OQ services to help our customers work towards GMP or other certifications and validations a customer might need in their production facility. Other certifications may be dictated by local standards and government regulations. It is the customers responsibility to have their entire process validated and put into compliance to be considered GMP certified.

    Are your Instruments and Accessories CE Certified?
    Yes all of applicable Dr. Oligo line of instruments and accessories are CE certified. CE Certificates available for an added cost.

    Are your Instruments and Accessories UL Certified?
    Yes our instruments are UL 60950-1 certified and must re-certified upon install.

    Are your Instruments and Accessories TUV Certified with NFPA 70/79 Field Label?
    Yes, we are able to provide the TUV Field Inspection and apply an NFPA 70/79 Field Label for each instrument or accessory for an added cost.