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 When carrying out the qualification / validation, we test with the finalcustomer the design, the installation, the functionality as well as the performance of the plant and the corresponding processes based on a detailled risk analysis in the below mentioned phases by means of documents and tests according to the criteria prescribed in the specifications. Over the past years, the VAKUMIX AG has achieved special competence and experiences with the validation of automated plants, e.g. acc. to standard 21 CFR Part 11 "Electronic Records, Electronic Signature" and acc. to GAMP 4. Please contact us. Together, we are finding the optimum solution for you. Within the scope of the Design Qualification (DQ), • all product-relevant calculations and constructional designs carried out within the scope of the Detail Engineering are submitted for approval and • a complete documentation of all approved components is provided. _______________________________________________ Next Page > |
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