Quality Management Software Solutions - Corrective Action Software, CAPA Solutions, Supplier Quality, Complaint Handling Software

By: Assurx  05/12/2011
Keywords: Quality Management, Issue Management, Quality Management Software



Benefits
  • Centralize CAPA Processing
  • Reduce Problems
  • Prevent Recurrences
  • Prioritize Resources
  • Reduce Costs
  • Decrease Cycle Times
  • Compliance (FDA, ISO, SOX, EMEA, NRC, etc.)

Features

  • Root Cause Analysis
  • Auto Escalation
  • Executive Dashboards
  • Configurable Reports
  • Ad-Hoc Query
  • Integration Tools
  • Built-In Reporting
  • 21 CFR Part 11 Compliant


Audit Management
Best Practice Audit Process
Comprehensive audit management process follows best practices for closed-loop findings; closure, task assignments and escalation. Audits are conducted after being planned, findings are classified and follow-up is assigned to area managers. After follow-up actions are addressed, a final report is issued and routed for closure.
Benefits
  • Increase Audit Consistency
  • Reduce Audit Cycle Times
  • Meet Regulatory Requirements
  • Reduce Errors & Missing Records
  • Compliance (FDA, ISO,SOX, EMEA, NRC, etc.)

Features

  • Internal & Supplier Audits
  • EH&S, Facilities
  • GXP, ISO, GAP, SOX
  • Auto Notification, Escalation
  • Ad-Hoc Query & Reporting
  • Integration Tools
  • 21 CFR Part 11 Compliant


Manufacturing Quality:
Incidents, Requests, Corrective Action
Best Practice Issue Management
Comprehensive manufacturing quality tracking follows best practices from ISO and GMP standards. Includes closed-loop issue and change request management from initiation through disposition and corrective action. Track trends, cycle times and costs to facilitate root cause analysis and improve efficiencies.
Benefits
  • Reduce Time To Market
  • Increase Yields
  • Continuous Improvement
  • Facilitate Project Collaboration
  • Reduce Development Costs
  • Reduce Product Change Costs

Features

  • Engineering Change Orders
  • Project Management
  • Prototype Issue Management
  • Corrective/Preventive Action
  • Auto Notification, Escalation
  • Ad-Hoc Query & Reporting
  • Audit Trail, E-Signatures


Procedures Management:
Closed-loop Procedures Management
Benefits
  • Centralized Content Control
  • Reduce Errors & Cycle Times
  • Eliminate Wrong Document Use
  • Increase Security, Control Access
  • Lower Operating Costs
  • Compliance (FDA, ISO,SOX, EMEA, NRC, etc.)

Features

  • Document Repository
  • Change & Revision Management
  • Review & Approval Routing
  • Training Notification
  • Search Documents and Metadata
  • Ad-Hoc Query & Reporting
  • Integration Tools
  • 21 CFR Part 11


Automate all customer related events including complaints, returns, service calls and product improvement requests. Drive best practices process workflows based on event type and severity. Improve customer satisfaction and responsiveness with escalation management..

Benefits

  • Increase Customer Satisfaction
  • Increase Responsiveness
  • Reduce Fields Failures
  • Prevent Recurrences
  • Reduce Recalls
  • Meet Regulations (MDR, Vigilance, etc.)

Features

  • Product Complaints, Returns
  • Adverse Events
  • Field Service Requests
  • Improvement Suggestions
  • Corrective/Preventive Action
  • Auto Notification, Escalation
  • Ad-Hoc Query & Reporting
  • 21 CFR Part 11


Benefits

  • Increase Supplier Quality
  • Improve On-Time Deliveries
  • Reduce Shortages
  • Reduce Correction Cycle Times
  • Reduce Purchased Parts Costs
  • Compliance (FDA, ISO,SOX, EMEA, NRC, etc.)

Features

  • Manage Supplier Audits & Findings
  • Supplier Score Cards
  • Log Incoming Inspection Problems
  • Track Late & Short Shipments
  • Collaborate on Corrective Actions
  • Auto Notification, Escalation
  • Ad-Hoc Query & Reporting
  • 21 CFR Part 11


Benefits

  • Reduce Time To Market
  • Increase Yields
  • Continuous Improvement
  • Facilitate Project Collaboration
  • Reduce Development Costs
  • Reduce Product Change Costs

Features

  • Engineering Change Orders
  • Project Management
  • Prototype Issue Management
  • Corrective/Preventive Action
  • Auto Notification, Escalation
  • Ad-Hoc Query & Reporting
  • Audit Trail, E-Signatures

Keywords: Issue Management, Quality Management, Quality Management Software

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05/12/2011

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