Life Sciences, Compliant Manufacturing Framework^®

EnteGreat's Compliant Manufacturing Framework^® (CMF) is a comprehensive library of SAP-based best practices for executing regulated manufacturing within the Life Sciences industries. By extending SAP to the shop floor, companies leverage their SAP investments to provide an integrated supply chain execution environment that enables compliant manufacturing and delivers profound business value. The CMF framework provides modular, configurable software objects (based on standard SAP product functionality) and related materials that dramatically reduce overall project risk and accelerate the development of an SAP-based cGMP shop floor execution environment. This environment provides manufacturing execution-level functionality within SAP thus minimizing the cost of integration and leveraging a single set of master data (within SAP) to provide "One Version of the Truth".

Critical functionality provided by the CMF includes:

• Enforced Manufacturing Workflow
• 21 CFR Part 11 Compliant Electronic Signature Strategies
• Creation of Electronic Batch Records
• Enhanced Cockpit for Shop Floor Usability
• Integration with Shop Floor Equipment
• Download of Current Versions of Recipes and Parameters
• Automated Data Collection (from SAP via OPC)
• Data Integrity Checking
• Material Tracking
• Qualification
• Materials
• Personnel (training records)
• Process
• Equipment (calibration, cleaning status, sterility, etc.)
• Environmental Conditions
• Shop Floor Quality Management
• Non-Conformance Management
• CAPA
• Common Product Release
• Batch Review/Dispositioning
• Exception-based Product Release

EnteGreat's CMF library is based on the following:

• Proven templates for defining manufacturing objects and activities in a cGMP environment using industry standards (ISA-88 and ISA-95)
• Proven configurable software modules, templates, and examples for configuring and implementing cGMP manufacturing applications
• Proven content for US FDA/GAMP Computer Systems Validation documentation
• Proven content for change management and training materials as well as system and user documentation

Compliant Manufacturing Framework^® reduces risk, accelerates projects, and helps Life Sciences manufacturing companies move from the desirable to the possible, and from the possible to the practical.

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