1. www.rescop.com 1 Regulatory System Compliance Partners

2. Rescop B.V. – Regulatory System Compliance Partners InnovativesolutionsforGxPcompliance of automatedsystems, document management and CAPA Address: Victorialaan 15 P. O. Box 3009 5203 DA´s – Hertogenbosch The Netherlands Contact: Tel: + 31 (0) 73 7506625 Fax: + 31 (0) 73 7506627 Email: info@rescop.com www.rescop.com

3. www.rescop.com 3 Compliance Software Solutions: RC-DMS Document Management System RC-CAPA DeviationHandling, CAPA and ChangeControlRC-CMDB Inventory ManagementRC-VMP ValidationMaster PlanningRC-Logbook Scheduling & LoggingRC-SDLC Validation, Qualification and CommissioningRC-ECMS EnterpriseCompliance Management Suite www.rescop.com 3 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

4. www.rescop.com 4 Objective of RC-DMS Store, manage and publish quality documentation (e.g. SOPs, validation documentation etc.) in accordancewithGxPregulations. Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

6. Storage, review and approval of documentation

7. Publish and search for documentation

8. Configure document types and corresponding review and approval workflows

9. Version Management

10. Possibility to print authentic copies

11. Management reportingwww.rescop.com 5 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

13. Standardized and efficient document workflow

14. Centrally and readily retrievable documentation

15. Paperlesscompliance

16. 21 CFR part 11 and annex 11 compliantwww.rescop.com 6 www.rescop.com 6 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

17. www.rescop.com 7 RC-DMS www.rescop.com 7

18. www.rescop.com 8 Objective of RC-CAPA Register and manage deviations, corrective & preventive actions and changes in accordance with GxP regulations. Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

20. Automated workflow for review and approval

21. Notifications and alerts (incl. escalation) by email

22. Management reportingwww.rescop.com 9 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

24. Centrally and readily retrievable deviations, corrective & preventive actions and changes

25. Consistent DeviationHandling, Corrective & PreventiveActions and Change Control processes through standardization of approach and contentwww.rescop.com 10 www.rescop.com 10 www.rescop.com 10 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

27. Paperlesscompliance

28. Traceability of all open and closed activities

29. 21 CFR part 11 and annex 11 compliantwww.rescop.com 11 www.rescop.com 11 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

30. www.rescop.com 12 RC-CAPA www.rescop.com 12 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

31. www.rescop.com 13 Objective of RC-CMDB Maintain a registration of automated systems, their status and their configuration. Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

33. Configurable system overviews

34. Register system components, incl. hardware, software, equipment, documentation and users

35. Baseline reporting

36. Supplier management

37. Management reportingwww.rescop.com 14 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

39. In control through an overview on the company’s systems and their compliance status

40. Full traceability of all configuration changes during the total lifecycle of the system.

41. 21 CFR part 11 and annex 11 compliantwww.rescop.com 15 www.rescop.com 15 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

42. www.rescop.com 16 RC-CMDB www.rescop.com 16 Rescop–Challenges -Introduction RC-ECMS – Advantages - Pricing

43. www.rescop.com 17 RC-CMDB www.rescop.com 17

45. Register maintenance, management and use of automated systems in a GxP compliant electronic logbook.Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

47. Automated generation and assignment of tasks

48. Notifications and alerts (incl. escalation) by email

49. Registration of results in electronic logbook

50. Approval of results

51. Definition of default activity recurrences and frequencies per system type

52. Trend reporting

53. Management reportingwww.rescop.com 19 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

55. Centrally and readily retrievable logbooks

56. Standardisation of logbookinformation

57. Consistency through definition of default activity recurrences and frequencies per system type

58. Paperlesscompliance

59. 21 CFR part 11 and annex 11 compliantwww.rescop.com 20 www.rescop.com 20 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

60. www.rescop.com 21 RC-Logbook www.rescop.com 21 www.rescop.com 21 www.rescop.com 21 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

61. www.rescop.com 22 RC-Logbook www.rescop.com 22 www.rescop.com 22 www.rescop.com 22 www.rescop.com 22 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

62. www.rescop.com 23 Objective of RC-VMP Generate and maintain site / departmental Validation Master Plans accordingEudralex volume 4 Annex 15 requirements. Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

64. Generate, review and approve VMP documents

65. Publish and search for VMPs

66. Scheduling and triggering of periodic VMP updates

67. Management reportingwww.rescop.com 24 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

69. Standardization of VMP content

70. Efficient document workflow

71. Centrally and readily retrievable VMPs

72. Paperlesscompliance

73. According Eudralex volume 4 annex 15

74. 21 CFR part 11 and annex 11 compliantwww.rescop.com 25 www.rescop.com 25 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

75. www.rescop.com 26 RC-VMP www.rescop.com 26 www.rescop.com 26 www.rescop.com 26 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

76. www.rescop.com 27 RC-VMP www.rescop.com 27 www.rescop.com 27 www.rescop.com 27 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

77. www.rescop.com 28 Objective of RC-SDLC Manage and support the validation, qualification and commissioning of automatedsystems. Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

79. Generateanappropriatevalidation/qualification/commissioningapproach for a given system

80. Dashboard providing an overview on the validation/qualification/ commissioning process and access to the corresponding documents

81. Content management, incl. integrated requirement- and test management

82. Library for definition and inheritance of default requirements and test scripts

83. Automated workflow for generation, review and approval of documentswww.rescop.com 29 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

85. View documents of similar systems

86. Import requirements and test scripts from existing documentationorlibrary

87. SupplierAssessment and Selection

88. AutomatedTraceability Matrix

89. Test registration (including documented evidence) and defect handling

90. Change control, incl. version management for software

91. Management Reportingwww.rescop.com 30 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

93. Centrally and readily retrievable documentation

94. Efficient document review and approval through automated workflow

95. Consistent and adequate validation/qualification/commissioning through standardization of approach, documentation and content

96. Speeding up of the validation/qualification/ commissioningprocessthroughreuse of content

97. Paperlesscompliance

98. 21 CFR part 11 and annex 11 compliantwww.rescop.com 31 www.rescop.com 31 www.rescop.com 31 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

99. www.rescop.com 32 RC-SDLC www.rescop.com 32 www.rescop.com 32 www.rescop.com 32 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

100. www.rescop.com 33 RC-SDLC RC-SDLC www.rescop.com 33 www.rescop.com 33 www.rescop.com 33 www.rescop.com 33 www.rescop.com 33 www.rescop.com 33 www.rescop.com 33 Rescop–Challenges -Introduction RC-ECMS – Advantages - Pricing Rescop–Challenges -Introduction RC-ECMS – Advantages - Pricing

101. www.rescop.com 34 RC-SDLC RC-SDLC www.rescop.com 34 www.rescop.com 34 www.rescop.com 34 www.rescop.com 34 www.rescop.com 34 www.rescop.com 34 www.rescop.com 34 www.rescop.com 34 Rescop–Challenges -Introduction RC-ECMS – Advantages - Pricing Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

102. Objective of RC-ECMS Control, support and integrate all processes required for GxP compliance of automatedsystems. Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

104. Integration and automation of the variousprocessesenablespaperless compliance;

105. The system can be integrated with any existing systems within the company that are involved in automatedsystem compliance;

106. The various products allow for a phased roll-out of the system.Each product can be configured according the company’s compliance approach and needs. www.rescop.com 36 www.rescop.com 36 www.rescop.com 36 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

107. RC-ECMS diagram Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

109. Consistent and adequate execution of compliance processes through standardization of approach, documentation and content

110. Centrally and readily retrievable documentation

111. Management reportingwww.rescop.com 38 www.rescop.com 38 www.rescop.com 38 www.rescop.com 38 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

113. Integration of complianceprocesses

114. Re-use of deliverables and content

115. Risk-based approach and decision mechanism

116. Central point for storing and sharing compliance documentation and knowledgePaperlesscompliance 21 CFR part 11 and annex 11 compliant www.rescop.com 39 www.rescop.com 39 www.rescop.com 39 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

117. www.rescop.com 40 RC-ECMS www.rescop.com 40 www.rescop.com 40 www.rescop.com 40 www.rescop.com 40 www.rescop.com 40 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

118. www.rescop.com 41 RC-ECMS www.rescop.com 41 www.rescop.com 41 www.rescop.com 41 www.rescop.com 41 www.rescop.com 41 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

119. Compliance software can be purchased and is available as software as a service Questions

120. For more information, please feel free to send your email to: info@rescop.com Or visit our website: www.rescop.com