Ensure accurate and consistent data recording to perform analyses and more easily fulfill regulatory requirements

Data integrity

Data integrity is the cornerstone of regulatory compliance (GMP) and successful process management. That is why it is important to ensure that core process data is archived and organized in a complete, accessible and undisputable way, resulting in a single representative copy of the data for further use. In separated and unconnected production, each machine has to be treated as critical (GMP) data storage. Consequently, data archiving plans and procedures need to be developed (limited local storage!) and staff appropriately trained. Documentation, qualifications and validations are more complex. However, once data infrastructure is properly put in place with supporting IT solutions, it is much easier to perform comprehensive analyses and fulfill regulatory inquiries, as well as to maintain data integrity.

The MePIS solution set makes it easy to achieve full data integrity:

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)