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