Solutions
CAPA / Nonconformance Management Software- Capabilities and Benefits
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Oct 26, 2005, 12:27

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

The Integrated Compliance Platform

Pilgrim’s SmartCAPA is a fully-integrated part of the Pilgrim Software’s Enterprise Compliance and Quality Platform. Pilgrim Software provides an enterprise–wide solution for managing corrective and preventive actions, complaint handling, change control management, internal and external audits, document control, SOP enforcement, engineering collaboration, employee certification and training, equipment/calibration, supplier quality management, advanced quality planning and risk 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.