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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

CO2 Incubator Installation Qualification & Operational Qualification Services

Installation Qualification & Operational Qualification
Ordering Information		 IQ/OQ GxP OQ GxP IQ/OQ OQ
CellXpert® 0082 060 302 0082 060 303    
S41i Incubator Shaker     0082 050 009 0082 050 008
CO2 Incubator – Galaxy series     0082 060 009 0082 060 008
Includes:        
Check of delivery status, and installation environment ■   ■  
Installation of instrument incl. configuration and functional check ■   ■  
Basic IQ report     ■  
Detailed IQ report ■      
Test of alarm functions ■ ■ ■ ■
Verification of instrument parameters (e.g. temperature, CO2, speed, alarm) ■ ■ ■ ■
Basic OQ report     ■ ■
Detailed OQ report ■ ■    
Handling of deviation list/management ■ ■    
Signed approval by customer and service technician ■ ■ ■ ■

Attn: This table lists only the most important service operations by plan. The provided service report will show the complete service operations performed.

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