Orderly processes, adherence to operating procedures and systematic supporting documentation simplify compliance with regulatory standards

Regulatory Compliance (GMP Compliance)

To ensure consistently high product quality, regulatory bodies have defined a set of minimal standard requirements that must be met by manufacturers. GMP and other practices set standards for production processes, operating procedures, documentation, staff training and quality management. It is particularly important for manufacturers to be able to trace process data and any changes to it. Additionally, there is strong focus on tracing activities and approval processes for individual production operations to ensure that prescribed workflows are properly executed. Therefore, corresponding systems need to be put in place to ensure high traceability of processes and materials, compliance with regulatory requirements and standards, and product quality and safety.

The MePIS solution set helps you to more easily fulfill GMP regulatory requirements:

MePIS UDG – Unified Data Gateway (Unlock access to production data for unlimited usage

MePIS RM – Recipe Management (Centrally manage production recipe parameters and the full recipe life-cycle process)

MePIS PDM – Process Data Management (Prepare advanced reports, gain a live production overview and analyze batch data)

MePIS MES – Manufacturing Execution System (Establish control over production processes and materials)

MePIS LB – Electronic Log Book (Track your GMP-relevant events in production)

MePIS GenCode – Serialization and Aggregation (Easily meet anti-counterfeiting and Track & Trace technical and regulatory requirements)