CAPA Management – Global Deviation and Nonconformance Management

Overview

Pilgrim's CAPA Management Solution is a closed-loop CAPA management system to assist regulated industries in maintaining compliance. CAPA Management allows users in any department to capture an event, determine if it is a problem and assess any associated risk, investigate to the appropriate level, and capture and track the all correction, corrective and preventive actions, with the ability to review for CAPA effectiveness. By facilitating an effective CAPA process, CAPA Management helps to resolve issues quickly and prevent recurrence – ensuring your organization’s future well-being and compliance with industry and regulatory requirements.

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Key Capabilities

Manage your Entire Value-Chain

CAPA Management helps you manage nonconformances/deviations throughout your value-chain, from the initial design and testing phase and then into production, where you can capture events from supplier receiving or incoming inspections, through manufacturing incidents: process deviations, out-of-specifications, machine failures, and supplier or contractor incidents to services issues and customer complaints.

Shorten Time-to-Resolution and Implementation

As your global event repository, Pilgrim’s CAPA Management, helps you identify the occurrence of nonconformances or any other quality issue throughout your organization, and facilitate investigation and “action” collaboration. With email notification and configurable best practice workflows, the system enables you to collaborate with responsible parties on tasks and investigations to quickly resolve issues. Milestone dates, with escalation triggers, ensure that CAPAs are closed-out on time. You can also communicate rapidly and clearly with suppliers about dispositions affecting them. A wide range of search options help you swiftly locate CAPA records, event records, and related information.

Ensure CAPA Effectiveness

CAPA Management’s investigation process lets you map preventive actions to their root causes to eliminate problems at their source and prevent recurrence. Validate your corrective or preventive actions and schedule a review for verification to ensure that a corrective or preventive action truly has been effective. Failure mode monitoring capabilities enable you to establish thresholds that will identify when an adverse trend is developing so you can determine if a CAPA has failed to eliminate a recurring problem and enabling you to monitor and control emerging risks.

Integration with Core Systems

By integrating with other core business systems, Pilgrim’s CAPA Management eliminates islands of information to ensure that changes are implemented quickly and consistently across your business. For manufacturing organizations, integration with leading MES & ERP systems helps to provide a complete “as-built” and “as-maintained” product event tracking solution, with standard integrations to select unique “part/lot” information and configure the data to automatically populate into event entry records. Integration with Pilgrim’s Document Management solutions ensures that changes affecting SOPs are automatically implemented. Integration with Training Management allows you to automatically update employee training processes and schedule new training when needed.

Security and Regulatory Requirements

With role-based document securities, powerful password authentication, and a complete audit trail, Pilgrim’s CAPA Management helps you facilitate IT and industry compliance with requirements for electronic signature and electronic records. CAPA Management can be used for internal, industry standards and requirements from various government regulations.

Continuous Improvement

With pre-packaged, configurable reporting capabilities, CAPA Management provides you with real-time visibility so you can identify regulatory threats and areas of improvement, and make timely, informed decisions. CAPA Management helps you ensure that things are done right the first time – driving continuous improvement throughout your business.

The Integrated Compliance Platform

CAPA Management is a fully-integrated part of Pilgrim Software’s Enterprise Compliance and Quality Platform. Pilgrim Software provides an enterprise–wide solution for managing corrective and preventive actions, complaint handling, internal and external audits, 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 industry and regulatory requirements, increase efficiency and reduce costs.

Features & Benefits

Pilgrim CAPA Management -- Key Features & Benefits:

Capabilities	Benefits
Global Deviation and Nonconformance Management
Inherit Policies	Enforce standard by enabling sites to inherit corporate policies and workflows
Web-based Forms	Configure form to capture data by event-type: enter one or multiple products, lots and failures, from complex manufacturing events to simple nonconforming events
Product Corrections
Investigations & Implementations	Identify the root cause of an issue to eliminate problems at their source and prevent recurrence
Review Verifications	Initiate and schedule reviews to ensure that issues have been addressed successfully
Shorten Time-to-Resolution
Workflow Management	Route problems to the appropriate person or department to ensure rapid investigation
Electronic Material Review Board (MRB)	Electronically convene MRBs to assess the impact of a problem or document the MRB decisions by part / lot
Milestones	Schedule and manage milestone dates to ensure that investigations are closed out on time
Escalation	Eliminate bottlenecks by automatically elevating incomplete tasks and reviews
Things-to-Do List	Keep your entire organization up-to-date on tasks and work items needing attention
Milestones	Notify affected parties via e-mail to ensure prompt attention to tasks and CAPA issues
Search & Full Text Search on Attachments	A variety of search capabilities help you to rapidly locate CAPA records and related information
Ensure CAPA Effectiveness
Root Cause Analysis	Identify the true cause of a problem and determine the impact of CAPAs to prevent future occurrences
Follow-up Audits	Integrate with SmartAudit to schedule follow-up to ensure that a CAPA was successful
Failure Mode Monitorings	Identify adverse trends so a CAPA can be initiated before serious deviations occur
Continuous Improvement
Real-time Reporting	Configurable reports provide instant visibility into issues to enable informed decision making
Personal Queries	Users can create personalized queries to immediately analyze emerging problems
Change Management
Change Notification	Rapidly communicate changes to ensure that your entire organization is up-to-speed
Integration with Core Systems	Automatically enforce changes across all affected systems to ensure consistency
Integration with SmartDoc	Ensures that changes affecting SOPs are automatically implemented
SmartTrain Integration	Automatically schedule training to educate your workforce about changes and new processes