In industries like aseptic manufacturing of pharmaceutical medicinal products, facilities require Control (BMS) and Monitoring (EMS) solutions. Questions invariably arise regarding system validation. Since critical steps are mandated for Good Manufacturing Practices (GMP) based on validation and regulatory compliance, an EMS is authenticated based on validating that the system design meets the system’s functionality, which should be outlined in a User Requirement Specification (URS) document. A URS is typically developed following a formal risk analysis study of the facility, the processes, and the product critical locations. All EMS data must be GMP compliant: data records with timestamps and alarm details are used to provide evidence that a product batch has been manufactured in ideal environmental conditions and product quality, safety, and efficacy remained intact before market release.
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