| ELSE Automation provides Validation Experts with high experience, needed in project qualification, to establish a proper Control Systems installation and functionality. Our Validation Experts have the following competences: - GMP - FDA compliance and validation - Implementing of 21-CFR, Part 11 compliance - User Requirements Specification - Functional Requirements Specification - SOP’s - FAT at vendor location - SAT at customer site - Documentation. - Traceability and Requirements Management with DOORS® software The following Validation Experts are at your disposable: Ehret Ralph Probst Pascal |
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