Life Sciences, Compliant Manufacturing Framework^®

EnteGreat's Compliant Manufacturing Framework^® (CMF) is a comprehensive offering that includes consulting services, templates, methodology, and systems libraries to help our clients accelerate their implementation of SAP to support regulated manufacturing environments.

CMF is based on the lessons that EnteGreat has learned from helping Fortune 500 Life Science manufacturing companies implement programs for managing compliance at the plant level, tightly integrating manufacturing into the supply chain, and moving to faster, more reliable approaches for compliant manufacturing, such as release by exception for the disposition of batches based on electronic batch records.

CMF is designed to augment your existing SAP foot print and help accelerate the deployment of the appropriate SAP tools and modules for integrating your cGMP manufacturing environment. We have helped clients accomplish this by building their architecture to support integration of full capability MES systems, integrating batch management, SCADA and process historians, or simply by extending more user-friendly PI sheets and managing workflows to users on the shop floor. Many of our clients have found that all three approaches are appropriate for them to use, based on the diversity and differing levels of complexity in their plants.

EnteGreat's Compliant Manufacturing Framework^® 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 EnteGreat's 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 incorporates:

• 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

Learn More:
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