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Conformity Made Easy!
The Installation Qualification assures that the instrument is installed in accordance with Eppendorf’s specifications within defined test protocols.
The Operational Qualification assures that the instrument operates in accordance with Eppendorf’s specifications within defined test protocols.
- 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 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:
- 21 CFR Part 211 (USA)
- USP Good Documentation Guidelines
- MHRA GxP Data Integrity Guidance and Definitions
- WHO Technical Report Series, No 966, Annex 5
Biological Shaker Installation Qualification & Operational Qualification Services
| Installation Qualification & Operational Qualification |
|IQ/OQ GxP||OQ GxP|
|Open Air Shaker|
|Shaker with Heating|
|Shaker with heating and cooling|
|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. rpm, temperature, alarms)|
|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.