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.

New: Revised reports compliant with the relevant GxP standards & regulations

With our newly created 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    
New BrunswickTM S41i Incubator Shaker 0082 050 300 0082 050 301    
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.