The CSB System simplified and secured ERP validation as a pre-validated industry solution tailored for validation-required processes, consolidating all documentation within one ERP system. It implemented best practices including the four-eyes principle, audit trail, customizable batch documentation, plausibility checks for critical data, full traceability, and secure archiving. This ensured effortless compliance with European GMP and FDA guidelines for computer-aided systems impacting product quality, patient safety, and data integrity, providing an intelligent starting position for successful regulatory adherence without complexity.

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