1. www.etq.com | 1.800.354.4476 CONFIDENTIAL: This document contains information that is confidential and proprietary to EtQ, Inc. Disclosure, copying, distribution or use without the express permission of EtQ is prohibited. Copyright  2015 EtQ, Inc. All rights reserved. ISO 27001 Certified State of Pharmaceutical Quality, Compliance and Risk Management Full Survey Data 3/31/2015

2. www.etq.com | 1.800.354.4476 The Survey Survey conducted in partnership with Pharmaceutical Manufacturing Survey objective was to better understand approaches for quality, compliance and risk management being used by pharmaceutical and biopharmaceutical companies and the use of information technology within these efforts 131 surveys completed Manufacturing, quality assurance, quality control, compliance and regulatory professionals from leading pharmaceutical and biopharmaceutical companies comprised the respondent base

3. www.etq.com | 1.800.354.4476 Please classify your organization: (Please choose all that apply)

4. www.etq.com | 1.800.354.4476 Which Quality/Compliance processes do you consider to be your organization’s biggest pain points? (Please choose all that apply)

5. www.etq.com | 1.800.354.4476 How does your organization manage its QMS?

6. www.etq.com | 1.800.354.4476 Do you feel the Quality/Compliance Management system in use by your organization is effective in managing your quality and compliance needs?

7. www.etq.com | 1.800.354.4476 What have been the greatest benefits of your Quality/Compliance Management system? (Please choose all that apply)

8. www.etq.com | 1.800.354.4476 Why has your Quality/Compliance Management system not been effective in managing your quality and compliance needs? (Please choose all that apply)

9. www.etq.com | 1.800.354.4476 Do you feel that your organization has a robust CAPA process?

10. www.etq.com | 1.800.354.4476 What do you believe is the weakness of your CAPA process? (Please choose all that apply)

11. www.etq.com | 1.800.354.4476 How do you manage your CAPA process?

12. www.etq.com | 1.800.354.4476 Do you feel your company would be prepared to handle product recalls or withdrawals in an efficient and timely manner?

13. www.etq.com | 1.800.354.4476 Do you have recall or withdrawal plans in place?

14. www.etq.com | 1.800.354.4476 Do you feel you have a good traceability system to document the recall or withdrawals?

15. www.etq.com | 1.800.354.4476 Have you been involved in a product recall or withdrawal?

16. www.etq.com | 1.800.354.4476 How many product recall or withdrawals have you been involved in?

17. www.etq.com | 1.800.354.4476 Do you feel your organization is ready for an unannounced inspection or audit?

18. www.etq.com | 1.800.354.4476 How do you manage your audit/inspection processes?

19. www.etq.com | 1.800.354.4476 Do you have a comprehensive supplier audit program?

20. www.etq.com | 1.800.354.4476 Do you have a comprehensive supplier management program?

21. www.etq.com | 1.800.354.4476 What are the gaps within your supplier management program? (Please choose all that apply)

22. www.etq.com | 1.800.354.4476 How do you manage your supplier management processes?

23. www.etq.com | 1.800.354.4476 Is your organization using Risk to guide your actions?

24. www.etq.com | 1.800.354.4476 Are you using Risk to guide: (Please choose all that apply)

25. www.etq.com | 1.800.354.4476 What tools are you using to assess your risk? (Please choose all that apply)

26. www.etq.com | 1.800.354.4476 Do you feel your organization goes beyond assessing Risks and is actively managing Risks?

27. www.etq.com | 1.800.354.4476 We Think Global. VisibilityControl 20+ 95% www.etq.com blog.etq.com info@etq.com 1.800.354.4476