In today’s competitive Life Sciences industry, quality systems must operate as an integral component of the business and drive operational efficiency and continuous improvement. It should close the loop across all phases of the product lifecycle — from design through manufacturing to field use — and enable the enterprise to deliver the highest quality product, on time, every time.

Patni’s iCAPA solution integrates processes, reduces risks, streamlines information flow, improves operational efficiencies and helps meet desired quality levels and compliance requirements. The solution streamlines compliance and quality processes across the regulated product lifecycle. iCAPA embraces the closed-loop quality system approach by providing a framework, which seamlessly integrates a company’s SAP-based control systems (PP&C, QM, CRM, etc.) and non-SAP technologies (e.g., LIMS, MES, CRM, EDMS) with the quality monitoring and reporting capabilities within iCAPA.

iCAPA Features:

• Role-specific dashboards
• Automatic initiation of associated quality functions upon identification of nonconforming incidents
• Timely and effective incident management functions like identification, containment, and correction
• Full suite of centralized quality functions including risk assessment, investigation, root cause analysis, CAPA (Corrective and Preventive Action), effectiveness monitoring, and trending
• Continual analysis of Quality and Control System information
• Remediation and improvement actions flow back into the control system through a traceable change control process.

Value Proposition
Patni’s three-stage iCAPA solution approach delivers a compelling value proposition that ensures 10-30% improvement in quality processes with assured return on investment.

Stage 1: Compliance Driven Solution

• Assessment of quality system operations benchmarked against industry best practices.
• ‘Closed-Loop’ quality system improvement roadmap in line with business objectives.

Stage 2: Project Risk Mitigation

• Proof-of-concept (POC) that demonstrates efficacy of iCAPA well before implementation.
• Effective change management through a structured program for system integration and quality improvements.

Stage 3: Fast-track Implementation

• Proven regulatory compliant CAPA functions.
• Solution accelerators for 'Blueprint' and 'Build' phase of the implementation life cycle.
• Compliance and validation expertise to help ensure compliance.