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ValidationWe validate according to the regulations and guidelines of the FDA, GMP und DIN/ISO 9001 |
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| Validation is the provision of objective evidence in agreement with the principles of Good Manufacturing Practice (GMP) to the effect that methods, processes, equipment items, materials, work cycles or systems actually achieve the expected results. | ||
Computer Validation |
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| Computer validation is the proof of the secure use of software and hardware components when using systems supported by computers. A classification of these computer supported systems according to their structure and GMP-relevant impact are made after the judgement of the Part 11-conformity. Our computer system validation refers to CFR 21 Part 11, EG GMP rules Annex 11 as well as GAMP rules. | ||
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Copyright by Mikutta Engineering |
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