| SmartCAPA - Effective Deviation Incidents and Nonconformance Management |
The need for rapid problem resolution can arise in any Life Science or manufacturing business environment. Overlooked, misidentified, or mishandled issues, when not recognized efficiently and resolved effectively, will almost certainly prove detrimental to an organization.
A company's reputation and even its degree of profitability will be adversely impacted.
Pilgrim's SmartCAPA, for corrective and preventive action, helps businesses overcome the risks. The closed-loop CAPA management software allows users in any department to initiate an investigation to quickly resolve an issue and prevent recurrence. This proactive approach ensures corporate well-being and industry and regulatory compliance.
SmartCAPA Shortens Time to Resolution
| Once you identify, through SmartCAPA, the occurrence of nonconformances, customer complaints, incidents, deviations, out-of-specifications, or any other quality issue, the solution enables you to collaborate with responsible parties on tasks and investigations to quickly resolve issues. A wide range of search options helps you swiftly locate CAPA records and related information, and milestone dates, with escalation triggers, ensure that CAPAs are closed-out on time. |
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| Nonconformance Resolution/CAPA Workflow - click here to enlarge | |
SmartCAPA Ensure CAPA Effectiveness
| Mapping preventive actions to their root causes eliminates problems at their source and establishes the roadmap to prevent recurrence. SmartCAPA also enables you to monitor and control emerging risks by allowing you to establish a threshold level of occurrences for a specific type of failure. This allows for pro-active notification when occurrences/recurrences happen, and helps mitigate risk by feeding historical information into the Risk Assessment phase of new product life-cycle development. SmartCAPA also captures the failure by part/lot to assist in Product Recall analysis for full traceability of nonconformanceís through product life-cycle. Scheduled reviews of completed CAPAs allow you to ensure that a corrective and preventive action was truly effective. |
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| Capture Unlimited Root Causes & Action Plans - click here to enlarge | |
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“Pilgrim's SmartCAPA effectively handles our customer complaints, action plans and shared best practice processes amongst our global team members. The configurable reports and trending capabilities that SmartCAPA produces will provide us with real-time visibility of the information needed to respond to customer and market demands swiftly.”
Bertrand Tandonnet, VP of Worldwide Logistics, Essilor |
SmartCAPA Integrates with Core Systems
| Through integration with other automated core management systems, SmartCAPA enables businesses to eliminate islands of information to ensure that changes are implemented quickly and consistently across the enterprise. For manufacturing organizations, SmartCAPA can be integrated with leading MES, ERP and LIMS systems to provide a complete tracking solution. Pilgrimís CAPA management software also can integrate with Pilgrimís SmartDoc, SmartTrain and SmartAudit for rapid, automatic process implementation. |
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| Product Nonconformance Entry - click here to enlarge | |
SmartCAPA Facilitates Compliance & Validation
| With role-based security, powerful password authentication, and a complete audit trail, SmartCAPA facilitates compliance with 21 CFR Part 11 requirements. SmartCAPA meets internal and industry standards industry standards and regulatory requirements such as: 21 CFR Part 11, FDA Parts 820, 210-211, 606, and 1270-1271; ISO 13485, 14001, and 9000; GMP, GLP, GCP; Sarbanes-Oxley (SOX); OSHA; EU, International Health Ministries; and more. |
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| Product Nonconformance Detail - clicke here to enlarge | |
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“SmartCAPA has proven to be an excellent tool for initiating and resolving corrective and preventive actions. To identify root causes and prevent recurrence of the original action has been cost-effective. Weíre also confident in our compliance with all the FDA requirements.”
Ben Greene, Sr. VP of Quality Assurance, Genzyme |
SmartCAPA Supports Continuous Improvement
Pilgrim developed the SmartSolve suite to help companies ensure things are done right the first time, driving continuous improvement. The SmartCAPA module, with its pre-packaged, configurable reporting capabilities, provides you with real-time visibility so you can identify regulatory threats and areas of improvement, and make timely, informed decisions.
The Integrated Compliance Platform
Pilgrim’s CAPA Management is a fully-integrated part of the SmartSolve® and Q&MIS® Integrated Compliance and Quality Platform. SmartSolve and Q&MIS provide an enterprise–wide solution for managing corrective and preventive actions, complaint handling, change control management, internal and external assessments, document control, SOP enforcement, employee certification and training, equipment/calibration and supplier quality management. This powerful solution enables you to manage quality and compliance across your entire business, helping you meet regulatory requirements, increase efficiency and reduce costs.
For an overview of capabilities and benefits, click here.
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