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Documented evidence
that shows that equipment and utilities are correctly
installed, working reliably within predefined operating
ranges and, as far as the final product is concerned,
lead to the desired result.
Our Offer
Consulting, staffing support and implementation in
- DQ - Design Qualification
- IQ - Installation Qualification
- OQ - Operational Qualification (incl.
calibration)
- PQ - Performance Qualification
Our Procedure
Based on tried and tested basic concepts or your individual
guidelines our expert process, chemical, pharmaceutical
or electrical engineers develop all of the necessary
qualification protocols including relevant SOPs and
prepare them for discussion within the validation team.
Upon request we will coordinate and moderate
the relevant validation team meetings (validation coordinator),
maintain activity lists and time schedules and supervise
the course of the project.
Our engineers will accompany and support
you during the subsequent qualification activities,
upon request independently and on their own responsibility.
We will collect and collate all records,
raw data and individual results according to GMP requirements
and then summarize these in the final qualification
reports.
Your Results A plant qualified according to the relevant GMP guidelines
together with all necessary qualification protocols
and reports. |
Consulting
