The document describes Rescop B.V., a company that provides regulatory compliance software solutions. It outlines several of Rescop's software products, including RC-DMS for document management, RC-CAPA for deviation handling and change control, RC-CMDB for asset and configuration management, RC-Logbook for scheduling and logging, RC-VMP for validation master planning, and RC-SDLC for validation, qualification and commissioning of automated systems. Each product is described in terms of its objectives, main functionality, advantages, and compliance with regulatory standards like GxP and 21 CFR Part 11.

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. Rescop philosophy for Validation Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

4. www.rescop.com 4 Compliance Software RC-DMS Document Management System RC-CAPA DeviationHandling, CAPA and ChangeControlRC-CMDB Asset & Configuration ManagementRC-VMP ValidationMaster PlanningRC-Logbook Scheduling & LoggingRC-SDLC Validation, Qualification and CommissioningRC-ECMS EnterpriseCompliance Management Suite www.rescop.com 4 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

5. www.rescop.com 5 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

7. Storage, review and approval of documentation

8. Publish and search for documentation

9. Configure document (sub)types and corresponding review and approval workflows

10. Configurable roles and rightswww.rescop.com 6 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

12. Version Management

13. Schedule and triggerperiodicreview of documents

14. Possibility to print authentic copies

15. Management Reportingwww.rescop.com 7 www.rescop.com 7 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

17. Standardized and efficient document workflow

18. Centrally and readily retrievable documentation

19. Paperlesscompliance

20. 21 CFR part 11 and annex 11 compliantwww.rescop.com 8 www.rescop.com 8 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

21. www.rescop.com 9 RC-DMS www.rescop.com 9

23. registration and monitoring of corrective and preventiveactions

24. change control, in accordance with GxP regulations. Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

27. Content and document management

28. Configurable workflow for process steps, review and approval

29. Configurable roles and rights

30. User interface depending on roles and rights

31. Notifications and alerts (incl. escalation) by e-mail

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

34. Centrally and readily retrievable deviations, corrective and preventive actions and changes

35. Consistent DeviationHandling, Corrective & PreventiveActions and Change Control processes through standardization of approach and content

36. Efficient review and approval through automated workflow

37. Paperlesscompliance

38. Traceability of all open and closed activities

39. 21 CFR part 11 and annex 11 compliantwww.rescop.com 13 www.rescop.com 13 www.rescop.com 13 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

40. www.rescop.com 14 RC-CAPA www.rescop.com 14 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

41. www.rescop.com 15 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

43. Configurable system overviews

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

45. Baseline reporting

46. Supplier management

47. Management reportingwww.rescop.com 16 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

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

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

51. 21 CFR part 11 and annex 11 compliantwww.rescop.com 17 www.rescop.com 17 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

52. www.rescop.com 18 RC-CMDB www.rescop.com 18 Rescop–Challenges -Introduction RC-ECMS – Advantages - Pricing

53. www.rescop.com 19 RC-CMDB www.rescop.com 19

55. Register incidents, 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

57. Automated generation and assignment of tasks

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

59. Registration of activities in electronic logbook

60. Approval of results

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

62. Trend reporting

63. Management reportingwww.rescop.com 21 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

65. Centrally and readily retrievable logbooks

66. Standardisation of logbookinformation

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

68. Paperlesscompliance

69. 21 CFR part 11 and annex 11 compliantwww.rescop.com 22 www.rescop.com 22 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

70. www.rescop.com 23 RC-Logbook www.rescop.com 23 www.rescop.com 23 www.rescop.com 23 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

71. www.rescop.com 24 RC-Logbook www.rescop.com 24 www.rescop.com 24 www.rescop.com 24 www.rescop.com 24 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

72. www.rescop.com 25 Objective of RC-VMP Generate and manage 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

74. Generate, review and approve VMP documents

75. Publish and search for VMPs

76. Scheduling and triggering of periodic VMP updates

77. Management reportingwww.rescop.com 26 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

79. Standardization of VMP content

80. Efficient document workflow

81. Centrally and readily retrievable VMPs

82. Paperlesscompliance

83. According Eudralex volume 4 annex 15

84. 21 CFR part 11 and annex 11 compliantwww.rescop.com 27 www.rescop.com 27 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

85. www.rescop.com 28 RC-VMP www.rescop.com 28 www.rescop.com 28 www.rescop.com 28 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

86. www.rescop.com 29 RC-VMP www.rescop.com 29 www.rescop.com 29 www.rescop.com 29 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

87. www.rescop.com 30 Objective of RC-SDLC Manage and support development, engineering, implementation, validation, qualification and commissioning of automated systems to ensure compliance with GxP-regulations and company procedures. Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

89. Generateanappropriatevalidation/qualification/commissioningapproach for a given system, based on configurable workflow

90. Integrated Risk Management

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

92. Content management, incl. integrated requirement and test management

93. Automated workflow for generation, review and approval of documentswww.rescop.com 31 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

95. Design Assistance

96. View documents of similar systems

97. Import requirements and test scripts from existing documentationorlibrary

98. SupplierAssessment & Selection

99. AutomatedTraceability Matrix

100. Test registration (incl. documented evidence) and defect handling

101. Change Control, incl. version management for software

102. Management Reportingwww.rescop.com 32 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

104. Centrally and readily retrievable documentation

105. Efficient document review and approval through automated workflow

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

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

108. Paperlesscompliance

109. 21 CFR part 11 and annex 11 compliantwww.rescop.com 33 www.rescop.com 33 www.rescop.com 33 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

110. www.rescop.com 34 RC-SDLC www.rescop.com 34 www.rescop.com 34 www.rescop.com 34 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

111. www.rescop.com 35 RC-SDLC RC-SDLC www.rescop.com 35 www.rescop.com 35 www.rescop.com 35 www.rescop.com 35 www.rescop.com 35 www.rescop.com 35 www.rescop.com 35 Rescop–Challenges -Introduction RC-ECMS – Advantages - Pricing Rescop–Challenges -Introduction RC-ECMS – Advantages - Pricing

112. www.rescop.com 36 RC-SDLC RC-SDLC www.rescop.com 36 www.rescop.com 36 www.rescop.com 36 www.rescop.com 36 www.rescop.com 36 www.rescop.com 36 www.rescop.com 36 www.rescop.com 36 Rescop–Challenges -Introduction RC-ECMS – Advantages - Pricing Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

113. 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

115. Integration and automation of the variousprocessesenablespaperlesscompliance;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

117. 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 39 www.rescop.com 39 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

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

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

121. Centrally and readily retrievable documentation

122. Management reportingwww.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

124. Integration of complianceprocesses

125. Re-use of deliverables and content

126. Risk-based approach and decision mechanism

127. Central point for storing and sharing compliance documentation and knowledgePaperlesscompliance 21 CFR part 11 and annex 11 compliant www.rescop.com 42 www.rescop.com 42 www.rescop.com 42 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

128. www.rescop.com 43 RC-ECMS www.rescop.com 43 www.rescop.com 43 www.rescop.com 43 www.rescop.com 43 www.rescop.com 43 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

129. www.rescop.com 44 RC-ECMS www.rescop.com 44 www.rescop.com 44 www.rescop.com 44 www.rescop.com 44 www.rescop.com 44 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS

130. Compliance software can be purchased and is available as software as a service For more information, please feel free to send your email to: info@rescop.com Or visit our website: www.rescop.com