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  • 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
  • 6. www.rescop.com
    6
    Main functionality of RC-DMS
    • Uploading of documents with common file types and generation of .pdf versions
    • 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 rights
    www.rescop.com
    6
    Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  • 11. Main functionality of RC-DMS - continued
    • User interface depending on roles and rights
    • 12. Version Management
    • 13. Schedule and triggerperiodicreview of documents
    • 14. Possibility to print authentic copies
    • 15. Management Reporting
    www.rescop.com
    7
    www.rescop.com
    7
    Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  • 16. www.rescop.com
    8
    Advantages of RC-DMS
    • GxPcompliant document management
    • 17. Standardized and efficient document workflow
    • 18. Centrally and readily retrievable documentation
    • 19. Paperlesscompliance
    • 20. 21 CFR part 11 and annex 11 compliant
    www.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
  • 22. www.rescop.com
    10
    Objective of RC-CAPA
    Manage and support:
    • handling of deviations, complaints, auditobservations, etc.
    • 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
  • 25. www.rescop.com
    11
    Main functionality of RC-CAPA
    • Register and handle CAPA cases:
    Case Initiation, incl. source (deviation, complaint, audit observation, etc.) and affected process
    Risk Assessment
    Root Cause Investigation
    Proposed Mitigation Actions (corrective and preventive), incl. link to change
    Results of Mitigation Actions
    Closure
    www.rescop.com
    11
    Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  • 26. Main functionality of RC-CAPA - continued
    • Register and handleChangeRequests
    • 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 Reporting
    www.rescop.com
    12
    www.rescop.com
    12
    Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  • 33. www.rescop.com
    13
    Advantages of RC-CAPA
    • GxPcompliantDeviationHandling, Corrective & PreventiveActions and ChangeControl
    • 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 compliant
    www.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
  • 42. www.rescop.com
    16
    Main functionality of RC-CMDB
    • Register automated systems, incl. use- and compliance status
    • 43. Configurable system overviews
    • 44. Register system components, incl. hardware, software, equipment, documentation and users
    • 45. Baseline reporting
    • 46. Supplier management
    • 47. Management reporting
    www.rescop.com
    16
    Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  • 48. www.rescop.com
    17
    Advantages of RC-CMDB
    • GxPcompliant system overviews
    • 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 compliant
    www.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
  • 54. www.rescop.com
    20
    Objective of RC-Logbook
    • Schedule and trigger maintenance, management and use of automatedsystems.
    • 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
  • 56. www.rescop.com
    21
    Main functionality of RC-Logbook
    • Scheduling of activities
    • 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 reporting
    www.rescop.com
    21
    Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  • 64. www.rescop.com
    22
    Advantages of RC-Logbook
    • Inspection readiness through scheduling and automated generation of tasks (incl. notifications and alerts)
    • 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 compliant
    www.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
  • 73. www.rescop.com
    26
    Main functionality of RC-VMP
    • Create, generate and maintain VMP content
    • 74. Generate, review and approve VMP documents
    • 75. Publish and search for VMPs
    • 76. Scheduling and triggering of periodic VMP updates
    • 77. Management reporting
    www.rescop.com
    26
    Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  • 78. www.rescop.com
    27
    Advantages of RC-VMP
    • GxPcompliantVMPs
    • 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 compliant
    www.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
  • 88. www.rescop.com
    31
    Main functionality of RC-SDLC
    • Integrated Project Management
    • 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 documents
    www.rescop.com
    31
    Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  • 94. www.rescop.com
    32
    Main functionality of RC-SDLC - continued
    • Libraryfordefinition and inheritance of defaultrequirements and test scripts
    • 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 Reporting
    www.rescop.com
    32
    Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  • 103. www.rescop.com
    33
    Advantages of RC-SDLC
    • GxP compliant validation/qualification/commissioning
    • 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 compliant
    www.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
  • 114. www.rescop.com
    38
    Main functionality of RC-ECMS
    Products are available per automated system compliance process, which has the following advantages:
    • Automated system compliance processes can be integrated to improve efficiency;
    • 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
  • 116. www.rescop.com
    39
    Main functionality of RC-ECMS - continued
    • The system can be integrated with any existing systems within the company that are involved in automatedsystem compliance;
    • 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
  • 119. www.rescop.com
    41
    Advantages of RC-ECMS
    Inspectionreadiness:
    • Traceability through automated linking of activities, deliverables and content
    • 120. Consistent and adequate execution of compliance processes through standardization of approach, documentation and content
    • 121. Centrally and readily retrievable documentation
    • 122. Management reporting
    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
  • 123. www.rescop.com
    42
    Advantages of RC-ECMS - continued
    Efficientcomplianceprocesses:
    • Automated workflow for review and approval
    • 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 knowledge
    Paperlesscompliance
    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