Business analysis for pre- and post-analytical automation systems

In order to subject a multi-year project to a quality analysis prior to the design input, existing requirements on pre- and post-analytical analysis devices that have been identified as incomplete, ambiguous or contradictory must be revised or supplemented or replaced by newly identified, tested, agreed and documented requirements. Given the strongly regulated environment in which the project is located, all quality-related and regulatory-related documents and artifacts are generated in an audit-proof manner and transferred to a customer-specific administration environment.