Implementing an effective Electronic CAPA Management System

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For all organisations who are required to manage their CAPA processes to maintain regulatory compliance, and who are struggling with a manual paper-based system. This informative presentation will cover:-

-Regulatory requirements for CAPA
-Elements of effective CAPA systems
-How and why your CAPA processes should integrate with other compliance activities
-Benefits of implementing an electronic CAPA management system 'v' a manual one

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Implementing an effective Electronic CAPA Management System

  1. 1. Implementing an effective Electronic CAPA Management SystemQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  2. 2. Gael Ltd – Leaders in Quality Thought leaders in the world of Quality, Compliance, Control and Audit  Founded in 1992  100+ employees  +600 Healthcare & Life Science Clients  Strong Customer Service ethos  Deloitte Fast 500 Growth company (25%+ growth year on year)Q-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  3. 3. Today’s objective  Regulatory requirements for CAPA  Elements of effective CAPA systems  How and why your CAPA processes should integrate with other compliance activities  Benefits of implementing an electronic CAPA management system v a manual oneQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  4. 4. The Reasons  Help Achieve an Organisation’s Objectives  Address Uncertainty  Support Correct Decision Making  Drive Performance ImprovementQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  5. 5. The Challenges – Staff Buy In Under used systems  Not user friendly  No obvious benefit to user  Poor communication and feedback loop Lack of awareness  No consistency  Must be top down approach led by management  Culture shift – feed the CAPA systemQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  6. 6. The Challenges - Visibility All control points flow through CAPA system  Deviations / NCRs  Audit Findings  Equipment monitoring  Staff Training  Change Control  OOS  Complaints  Product recalls / returns  Adverse events  Management Review Managing the ripple effect across all areas is problematic and difficult to maintainQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  7. 7. The Challenges - Regulatory 21 CFR 820.100 Corrective and Preventive Action  Establish a CAPA Procedure  Analyse with statistical methodology sources of quality data to identify sources of quality programmes ISO 13485 8.5.2 Corrective Action  Organisation shall take action to eliminate the cause of nonconformities to prevent recurrence  The corrective action shall be appropriate to the level of the effects of the non-conformance ISO 13485 8.5.3 Preventive Action  Organisation shall take action to eliminate the cause of nonconformities to prevent occurrence  The preventive action shall be appropriate to the effects of the non- conformance 21 CFR Part 11 Guidelines  Electronic Signatures  Full Audit Trails  Intruder Lock-out  Strong Passwords Electronic Systems Validation  IQ / OQ / PQQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  8. 8. The Challenges - Regulatory MHRA’s top 3 QMS related deficiencies  Incomplete or tardy recording and investigation of complaints and incidents  No regular review of quality indicators  Lack of quality improvement / CAPA processes FDA Warning Letters 2012  CAPA subsystem cited in 81 0f 89 FDA warding letters (91%)Q-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  9. 9. Common Scenarios Paper Based Systems  Paper based reporting forms  Information held in silos  Manual intervention Internally Developed Systems  Minimal development and support  Hybrid systems  Departmentalised  Lack of regulatory ControlQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  10. 10. Possible Solution An effective solution should provide  Accountability  Analytical intelligence  Encouragement to appropriate people  Simple event capture  Simple reporting  Effective notification  Reduction in risk How does Q-Pulse do it?Q-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  11. 11. Q-Pulse: Integrated SolutionQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  12. 12. Some of our customers …Q-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  13. 13. Typical Standards  ISO 9001  ISO 13485  FDA’s 21 CFR Part 820  FDA’s 21 CFR Part 11  EU GMP Annex 11  CPA / CAP / CLIA  AABB / BSQRQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  14. 14. What our Customers are saying “Putting Q-Pulse into place has changed the way we work considerably by providing us with a very user-friendly system that will ensure we can continue to meet our regulatory requirements and improve our services. Having all the information stored centrally allows easier and more efficient access for staff, management, and enables us to demonstrate our quality control mechanisms to external regulators” Dr Jennifer Cauchi, Quality Manager at BMDI Cord Blood Bank “We primarily sought out Q-Pulse to manage document control, but then we discovered its CA/PA, Asset and Training capabilities and were hooked.” Andrew Havens, Quality Assurance Manager, University of Utah Cell Therapy FacilityQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  15. 15. What our Customers are saying “Internal and external inspections are critical to our activities, and the Q-Pulse Audit module helps us manage these activities and link any subsequent actions to the CA/PA module. Q-Pulse makes it easier to achieve compliance with our standards and regulations, providing us with the tools to implement simpler methods and processes to manage quality.” Kevin Bruce, Quality Manager at Roslin Cells, Edinburgh “Q-Pulse gives us a centralized way of managing our QMS documents and records, including all of our SOPs, in line with the record-keeping requirements of the FDA” Marilyn Jeffers, Quality Assurance Manager, Blood Bank of AlaskaQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  16. 16. Summary  Regulatory requirements for CAPA  Elements of effective CAPA systems  How and why your CAPA processes should integrate with other compliance activities  Benefits of implementing an electronic CAPA management system v a manual oneQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.
  17. 17. 4 Benefits of Adopting an Integrated Approach to CA PA Management  Gain company-wide commitment  Ensure competency of appropriate staff  Integrate root cause analysis into quality systems  Reinforce learning  Download from gaelquality.com nowQ-Pulse is a registered trademark of Gael Products Ltd. All rights reserved worldwide. Copyright © 2012 Gael Ltd.

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