Qualification services and documentation by Becomix
In the pharmaceutical industry, documentation and qualification are an important aspect in addition to the simple procurement of the plant. Becomix qualification services are provided by experienced engineers. We work in conformity with the latest industry standards of the pharmaceuticals industry.
Als Basis unserer Qualifizierungsleistungen dienen folgende Guidelines:
- ISPE Guideline
- Computervalidierung (CSV) unserer Automation nach GAMP Guideline
Our documentation contains, in addition to the complete machine documentation required according to CE, also the following qualification documentation for our plants and automations: design qualification (DQ), installation qualification (IQ) and operational qualification (OQ).
As part of our Factory Acceptance Test (FAT) and the Site Acceptance Test (SAT) we carry out the IQ and the OQ in collaboration with you. Training and instruction of your staff is also a fixed part of our service. The type and scope are matched to your requirements.
In the course of a workshop, we are also pleased to offer you, in addition to the standard risk assessment according to the CE machinery directive, the organisation of a risk analysis according to FMEA matched to your production process and the carrying out of it together with you.
A new material analysis allows a non-destructive material identification to be carried out at the complete device without the need to dismantle or damage any components. This is the ideal verification method, in particular for stainless steels.
The direct printout of the material certificate by the system conforms to FDA – CFR 21 part 11. Subsequent material validations for existing plants are possible as part of a re-qualification on site.
Our documentation corresponds to the current requirements for a GMP or FDA plant qualification. We will be happy to present the concept to you in a meeting.