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GxP Compliant Qualification Services - Conformity Made Easy!

Qualification Services

Installation Qualification

The Installation Qualification assures that the instrument is installed in accordance with Eppendorf’s specifications within defined test protocols.

Operational Qualification

The Operational Qualification assures that the instrument operates in accordance with Eppendorf’s specifications within defined test protocols.

Revised reports compliant with the relevant GxP standards & regulations

With our GxP compliant Installation Qualification & Operational Qualification services, we improved our IQ/OQ services to support you, especially when working in the regulated environment. Our revised IQ/OQ reports follow national and international standards, regulations and guidelines such as:

  • EU-GMP
  • 21 CFR Part 211 (USA)
  • USP Good Documentation Guidelines
  • MHRA GxP Data Integrity Guidance and Definitions
  • WHO Technical Report Series, No 966, Annex 5

Your advantages

  • Confidence in the quality of your results and safety of the instrument
  • Supporting compliance with the complex GxP standards and regulations
  • GxP compliant IQ/OQ documentation will give you peace of mind due to reduced workload for your qualification and regulatory audit process

Centrifuge Installation Qualification & Operational Qualification Services

Installation Qualification & Operational Qualification 
Ordering Information		 IQ/OQ GxP OQ GxP
Microcentrifuge w/o refrigeration 0082 020 300 0082 020 305
Microcentrifuge w refrigeration 0082 020 301 0082 020 306
Multipurpose centrifuge w/o refrigeration 0082 020 302 0082 020 307
Multipurpose centrifuge w refrigeration 0082 020 303 0082 020 308
Himac High-Speed Floorstanding Centrifuge 0082 020 221 0082 020 227
Himac Ultracentrifuge 0082 020 220 0082 020 226
Vacuum Concentrator 0082 020 012* 0082 020 011*
Includes:    
Check of delivery status, and installation environment ■  
Installation of instrument incl. configuration and functional check ■  
Detailed IQ report ■  
Test of alarm functions ■ ■
Verification of instrument parameters (e.g. temperature, speed) ■ ■
Detailed OQ report ■ ■
Handling of deviation list/management ■ ■
Signed approval by customer and service technician ■ ■

Info: Our service offers may differ by country. Please contact your local service representative for more information.

*non-conform