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GxP Compliant Qualification Services - Conformity Made Easy!

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.

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
New: Revised reports according to applicable GxP norms and regulations

With our newly developed GxP-compliant services installation qualification and operational qualification, we have improved our IQ/OQ services to support you in particular when working in a regulated environment. Our revised IQ/OQ reports are based on national and international standards, regulations and guidelines such as:

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

Mastercycler® Installation Qualification & Operational Qualification Services

Installation Qualification & Operational Qualification
Ordering Information
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)
Detailed OQ report
Handling of deviation list/management
Signed approval by customer and service technician

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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.