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Regulatory Support

IQ/OQ support and PQ guidance

Certifies instrument functionality and performance within published specifications

Includes certificates and records to fulfill GxP, FDA and EMEA requirements

IQ/OQ performed by Gyros-certified service engineers using equipment calibrated to NIST traceable standards

Products from Gyros are quality controlled and validated prior to delivery according to clearly defined processes. The IQ/OQ support and PQ guidance package extends this validation process.

The installation qualification/operational qualification process takes 3-4 days on-site and is performed by a Gyros-certified engineer. Services are fully documented and a signed report provided, Re-qualification services can be ordered when required.

Performance Qualification (PQ) guidance includes recommendations to help the user validate instrument performance after IQ/OQ.

Contact your local Gyros representative to discuss specific requirements

Hear more

Using Gyrolab in a validated environment

M. Kelley, Marian Kelley Consulting, Gyrolab Seminar 2010

Dr Kelley explains Rule 21 CFR Part 11 and how Gyrolab workstation's functional capabilities permit flexible and rapid method validation for pharmacokinetics in a GxP environment

Read more

Using Gyrolab in a validated environment

M. Kelley, Gyrolab Seminar, 2009

(PDF, 64.2 kB)

More Information

Gyrolab xP workstation

(PDF, 827.8 kB)
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Gyros immunoassay platform

See how Gyrolab products and nanoliter-scale technology transform performance and productivity

Develop and run immunoassays at nanoliter scale:

Ready to use on Gyrolab xP workstation

Designed for use with Gyrolab CDs

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