PharmaProc MES Platform
A State-Of-Art Manufacturing Execution System (MES) for Pharmaceutical Manufacturing for API, Formulation and BioPharma production facilities.
Out-Of-The-Box Process Templates for typical steps such as Weigh & Dispense, Granulation, Compression, Mixing, Tablet Coating, Fermentation, Distillation, Concentrator etc. are easily customizable for your specific manufacturing process, reducing implementation and maintenance effort and costs.
Process Templates cover both Manufacturing and Quality steps with audit controls. Process Tasks routing is based on RBAC (role-based-access-control) mechanism to Technicians and QA staff involved in the manufacturing process.
Features of the solution includes,
- Moving from paper-based manufacturing to paperless manufacturing (eBMR)
- Compliant with legal requirements such as US FDA CFR 21 Part11 and EU GMP guidelines
- Serialization Data generation
- Process Tasks routing based on RBAC mechanism
- Manufacturing and Quality steps driven by workflow
- Integration to external IT systems such as ERP modules (Materials Management, Production Planning etc)
- Integration to machines using SCADA/HMI interface
- Automation of Machine and Equipment maintenance tasks
- Process Analytics Data and Reports to provide insights into Operational Efficiency