As the world realigns to a new normal after the pandemic, pharmaceutical manufacturers are under considerable pressure to meet global demand by reducing cycle times while minimizing costs and meeting strict regulatory requirements.
Regulatory compliance with FDA norms
Performix xMES Electronic Batch Recording records production events and generates reports for every step of the product life cycle, from product design, system configuration, configuration changes, execution, to analytics, preempting and alerting about any compliance deficiencies.
Cost of process validation
The graphical and templatized design of product MBR/Procedures using Performix xMES Recipe Authoring drastically reduces the cost of process validation, since any changes to the product are localized to a few templates, and only the changed templates need to be validated.
Product innovation without process disruption
Performix xMES is designed for continuous product innovation, and ensures that the latest MBR/Procedure is automatically leveraged and executed, across Design, Planning, and Execution systems.
Compliance documentation and audit trail
Performix xMES Electronic Batch Recording combined with xMES Quality & Compliance produces all the documentation and audit trail required by regulatory authorities. It gives unprecedented visibility into the manufacturing process, including batch execution time, quality deviations, schedule compliance, product track and trace, and genealogy.