Achieve Regulatory Compliance By Design and Lower The Cost of Compliance

How EnteGreat Helps Our Life Sciences Manufacturing Clients Achieve Their Goals
Regulatory compliance is critical to Life Sciences manufacturers and represents a significant commitment in resources and capital from new product deployment to daily manufacturing operations. The on-going cost of maintaining this level compliance, as well as the costs adjusting to meet new regulations, is significant.

EnteGreat has helped clients reduce the cost of achieving compliance by leveraging industry standards and best practices to accurately define the manufacturing process, identify the critical to quality characteristics and establish full traceability. From this common understanding of the process, a cross-functional review of the Manufacturing, Quality Control and QA procedures are aligned to ensure appropriate coverage to the applicable regulatory agencies. Through the cross-functional review based on common definitions and risk assessments, clients can drastically reduce the costs of "non-value add" efforts, reduce risk/exposure, and enable a robust change management program.

Through the appropriate use of manufacturing information systems, compliance can be enforced at the point of use to ensure that the process is followed as specified and documented as required. Through this enforced compliance framework, the paradigm change for product review and release is changed, and review cycles are dramatically reduced as product release reviews are focused on the easily identifiable exceptions.

Significant cost reductions for maintaining compliance can be achieved by the use of "Lean" practices that emphasize re-use, disciplined change control, and a Compliance Management process to manage the interdependent elements within the overall compliance lifecycle (i.e.: validation, training, and documentation).

Compliance

Reduced Cost of Compliance Batch Record Creation and Review Product Release Computer Systems Validation   Proactive Quality Processes Compliant Manufacturing Critical To Quality Parameters   Reduction in Compliance Issues or Auditory Findings Improved Batch Review and Product Release Cycle Timing (Exception- Based) “Lean” Compliance Processes Focus on Compliance Value Chain     Regulatory or Auditory Findings Causing: Production Delays Product Release Delays Lost Sales Excessive Materials and Inventory Costs Product Recall Excessive Costs and Time for Quality Assurance and Compliance

BUSINESS OUTCOMES RISKS AVOIDED         HOW WE ENABLE

EnteGreat's Lean Compliance Approach   EnteGreat's GAMP Templates   EnteGreat Compliant Manufacturing Framework™   PAT   EnteGreat's Best Practices

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