Qualification Service
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.