The GMP-module is the core of the system
The GMP-module is responsible for the order organisation and thus is the link between the management and the production.
Organisational embedding:
- Employees, locations, rooms, measurement techniques, quality assurance, standing data, formulations, definition of the process parameters (optional), actual value taking, stock-taking-programs before the actual program is started, standing data is automatically updated
- Orders, positions, and lot retracement down to the package
- Posting of the formulations with the current active agent percentage
- Automatic adjustment of the compensation material before weighing of the last position
- Control of the weighing order (optional)
- If a machine is out of order: the assignment of the order is changed, automatic or manual choice of the master recipe without the host order being changed.
- Securing of the stock management on the host system because of the automatic back posting of the issued quantities (e.g. SAP interfacing). Permanent check of the quality decisions.
- Automatic creation of formulations (including automatic version control)
- Adjustment, formulation history, audit trail
- Definition of master recipes as well as amount-specific master recipes
- Process triggering according to the S88 standard
- Validated according to GAMP
- Automated lot organisation for tank lots including lot specifications in case of multiple fillings (including lot retracement)
- Continuous audit rail
- The securing of the production process is integrated into COSREWIS and thus it is even saved when there is a host system failure
- Proven system availability of COSREWIS: >99%
