www.rescop.com<br />1<br />Regulatory System Compliance Partners<br />
Rescop B.V. – Regulatory System Compliance Partners<br />InnovativesolutionsforGxPcompliance of automatedsystems,<br />doc...
Rescop philosophy for Validation<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – R...
www.rescop.com<br />4<br />Compliance Software<br />RC-DMS	Document Management System<br />RC-CAPA	DeviationHandling, CAPA...
www.rescop.com<br />5<br />Objective of RC-DMS<br />Store, manage and publish quality documentation (e.g. SOPs, validation...
www.rescop.com<br />6<br />Main functionality of RC-DMS<br /><ul><li>Uploading of documents with common file types and gen...
Storage, review and approval of documentation
Publish and search for documentation
Configure document (sub)types and corresponding review and approval workflows
Configurable roles and rights</li></ul>www.rescop.com<br />6<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Lo...
Main functionality of RC-DMS - continued<br /><ul><li>User interface depending on roles and rights
Version Management
Schedule and triggerperiodicreview of documents
Possibility to print authentic copies
Management Reporting</li></ul>www.rescop.com<br />7<br />www.rescop.com<br />7<br />Rescop – Challenges – RC-DMS – RC-CAPA...
www.rescop.com<br />8<br />Advantages of RC-DMS<br /><ul><li>GxPcompliant document management
Standardized and efficient document workflow
Centrally and readily retrievable documentation
Paperlesscompliance
21 CFR part 11 and annex 11 compliant</li></ul>www.rescop.com<br />8<br />www.rescop.com<br />8<br />Rescop – Challenges –...
www.rescop.com<br />9<br />RC-DMS<br />www.rescop.com<br />9<br />
www.rescop.com<br />10<br />Objective of RC-CAPA<br />Manage and support:<br /><ul><li>handling of deviations, complaints,...
registration and monitoring of corrective and preventiveactions
change control</li></ul>, in accordance with GxP regulations.<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-L...
www.rescop.com<br />11<br />Main functionality of RC-CAPA<br /><ul><li>Register and handle CAPA cases:</li></ul>Case Initi...
Main functionality of RC-CAPA - continued<br /><ul><li>Register and handleChangeRequests
Content and document management
Configurable workflow for process steps, review and approval
Configurable roles and rights
User interface depending on roles and rights
Notifications and alerts (incl. escalation) by e-mail
Management Reporting</li></ul>www.rescop.com<br />12<br />www.rescop.com<br />12<br />Rescop – Challenges – RC-DMS – RC-CA...
www.rescop.com<br />13<br />Advantages of RC-CAPA<br /><ul><li>GxPcompliantDeviationHandling, Corrective & PreventiveActio...
Centrally and readily retrievable deviations, corrective and preventive actions and changes
Consistent DeviationHandling, Corrective & PreventiveActions and Change Control processes through standardization of appro...
Efficient review and approval through automated workflow
Paperlesscompliance
Traceability of all open and closed activities
21 CFR part 11 and annex 11 compliant</li></ul>www.rescop.com<br />13<br />www.rescop.com<br />13<br />www.rescop.com<br /...
www.rescop.com<br />14<br />RC-CAPA<br />www.rescop.com<br />14<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC...
www.rescop.com<br />15<br />Objective of RC-CMDB<br />Maintain a registration of automated systems, their status and their...
www.rescop.com<br />16<br />Main functionality of RC-CMDB<br /><ul><li>Register automated systems, incl. use- and complian...
Configurable system overviews
Register system components, incl. hardware, software, equipment, documentation and users
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Presentation compliance software events and internet en

  1. 1. www.rescop.com<br />1<br />Regulatory System Compliance Partners<br />
  2. 2. Rescop B.V. – Regulatory System Compliance Partners<br />InnovativesolutionsforGxPcompliance of automatedsystems,<br />document management and CAPA<br />Address:<br />Victorialaan 15<br />P. O. Box 3009<br />5203 DA´s – Hertogenbosch<br />The Netherlands<br />Contact:<br />Tel: + 31 (0) 73 7506625<br />Fax: + 31 (0) 73 7506627<br />Email: info@rescop.com<br />www.rescop.com<br />
  3. 3. Rescop philosophy for Validation<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  4. 4. www.rescop.com<br />4<br />Compliance Software<br />RC-DMS Document Management System<br />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<br />www.rescop.com<br />4<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  5. 5. www.rescop.com<br />5<br />Objective of RC-DMS<br />Store, manage and publish quality documentation (e.g. SOPs, validation documentation, etc.) in accordancewithGxPregulations.<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  6. 6. www.rescop.com<br />6<br />Main functionality of RC-DMS<br /><ul><li>Uploading of documents with common file types and generation of .pdf versions
  7. 7. Storage, review and approval of documentation
  8. 8. Publish and search for documentation
  9. 9. Configure document (sub)types and corresponding review and approval workflows
  10. 10. Configurable roles and rights</li></ul>www.rescop.com<br />6<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  11. 11. Main functionality of RC-DMS - continued<br /><ul><li>User interface depending on roles and rights
  12. 12. Version Management
  13. 13. Schedule and triggerperiodicreview of documents
  14. 14. Possibility to print authentic copies
  15. 15. Management Reporting</li></ul>www.rescop.com<br />7<br />www.rescop.com<br />7<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  16. 16. www.rescop.com<br />8<br />Advantages of RC-DMS<br /><ul><li>GxPcompliant document management
  17. 17. Standardized and efficient document workflow
  18. 18. Centrally and readily retrievable documentation
  19. 19. Paperlesscompliance
  20. 20. 21 CFR part 11 and annex 11 compliant</li></ul>www.rescop.com<br />8<br />www.rescop.com<br />8<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  21. 21. www.rescop.com<br />9<br />RC-DMS<br />www.rescop.com<br />9<br />
  22. 22. www.rescop.com<br />10<br />Objective of RC-CAPA<br />Manage and support:<br /><ul><li>handling of deviations, complaints, auditobservations, etc.
  23. 23. registration and monitoring of corrective and preventiveactions
  24. 24. change control</li></ul>, in accordance with GxP regulations.<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  25. 25. www.rescop.com<br />11<br />Main functionality of RC-CAPA<br /><ul><li>Register and handle CAPA cases:</li></ul>Case Initiation, incl. source (deviation, complaint, audit observation, etc.) and affected process<br />Risk Assessment<br />Root Cause Investigation<br />Proposed Mitigation Actions (corrective and preventive), incl. link to change<br />Results of Mitigation Actions<br />Closure<br />www.rescop.com<br />11<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  26. 26. Main functionality of RC-CAPA - continued<br /><ul><li>Register and handleChangeRequests
  27. 27. Content and document management
  28. 28. Configurable workflow for process steps, review and approval
  29. 29. Configurable roles and rights
  30. 30. User interface depending on roles and rights
  31. 31. Notifications and alerts (incl. escalation) by e-mail
  32. 32. Management Reporting</li></ul>www.rescop.com<br />12<br />www.rescop.com<br />12<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  33. 33. www.rescop.com<br />13<br />Advantages of RC-CAPA<br /><ul><li>GxPcompliantDeviationHandling, Corrective & PreventiveActions and ChangeControl
  34. 34. Centrally and readily retrievable deviations, corrective and preventive actions and changes
  35. 35. Consistent DeviationHandling, Corrective & PreventiveActions and Change Control processes through standardization of approach and content
  36. 36. Efficient review and approval through automated workflow
  37. 37. Paperlesscompliance
  38. 38. Traceability of all open and closed activities
  39. 39. 21 CFR part 11 and annex 11 compliant</li></ul>www.rescop.com<br />13<br />www.rescop.com<br />13<br />www.rescop.com<br />13<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  40. 40. www.rescop.com<br />14<br />RC-CAPA<br />www.rescop.com<br />14<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  41. 41. www.rescop.com<br />15<br />Objective of RC-CMDB<br />Maintain a registration of automated systems, their status and their configuration.<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  42. 42. www.rescop.com<br />16<br />Main functionality of RC-CMDB<br /><ul><li>Register automated systems, incl. use- and compliance status
  43. 43. Configurable system overviews
  44. 44. Register system components, incl. hardware, software, equipment, documentation and users
  45. 45. Baseline reporting
  46. 46. Supplier management
  47. 47. Management reporting</li></ul>www.rescop.com<br />16<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  48. 48. www.rescop.com<br />17<br />Advantages of RC-CMDB<br /><ul><li>GxPcompliant system overviews
  49. 49. In control through an overview on the company’s systems and their compliance status
  50. 50. Full traceability of all configuration changes during the total lifecycle of the system.
  51. 51. 21 CFR part 11 and annex 11 compliant</li></ul>www.rescop.com<br />17<br />www.rescop.com<br />17<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  52. 52. www.rescop.com<br />18<br />RC-CMDB<br />www.rescop.com<br />18<br />Rescop–Challenges -Introduction RC-ECMS – Advantages - Pricing<br />
  53. 53. www.rescop.com<br />19<br />RC-CMDB<br />www.rescop.com<br />19<br />
  54. 54. www.rescop.com<br />20<br />Objective of RC-Logbook<br /><ul><li>Schedule and trigger maintenance, management and use of automatedsystems.
  55. 55. Register incidents, management and use of automated systems in a GxP compliant electronic logbook.</li></ul>Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  56. 56. www.rescop.com<br />21<br />Main functionality of RC-Logbook<br /><ul><li>Scheduling of activities
  57. 57. Automated generation and assignment of tasks
  58. 58. Notifications and alerts (incl. escalation) by email
  59. 59. Registration of activities in electronic logbook
  60. 60. Approval of results
  61. 61. Definition of default activity recurrences and frequencies per system type
  62. 62. Trend reporting
  63. 63. Management reporting</li></ul>www.rescop.com<br />21<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  64. 64. www.rescop.com<br />22<br />Advantages of RC-Logbook<br /><ul><li>Inspection readiness through scheduling and automated generation of tasks (incl. notifications and alerts)
  65. 65. Centrally and readily retrievable logbooks
  66. 66. Standardisation of logbookinformation
  67. 67. Consistency through definition of default activity recurrences and frequencies per system type
  68. 68. Paperlesscompliance
  69. 69. 21 CFR part 11 and annex 11 compliant</li></ul>www.rescop.com<br />22<br />www.rescop.com<br />22<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  70. 70. www.rescop.com<br />23<br />RC-Logbook<br />www.rescop.com<br />23<br />www.rescop.com<br />23<br />www.rescop.com<br />23<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  71. 71. www.rescop.com<br />24<br />RC-Logbook<br />www.rescop.com<br />24<br />www.rescop.com<br />24<br />www.rescop.com<br />24<br />www.rescop.com<br />24<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  72. 72. www.rescop.com<br />25<br />Objective of RC-VMP<br />Generate and manage site / departmental Validation Master Plans accordingEudralex volume 4 Annex 15 requirements.<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  73. 73. www.rescop.com<br />26<br />Main functionality of RC-VMP<br /><ul><li>Create, generate and maintain VMP content
  74. 74. Generate, review and approve VMP documents
  75. 75. Publish and search for VMPs
  76. 76. Scheduling and triggering of periodic VMP updates
  77. 77. Management reporting</li></ul>www.rescop.com<br />26<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  78. 78. www.rescop.com<br />27<br />Advantages of RC-VMP<br /><ul><li>GxPcompliantVMPs
  79. 79. Standardization of VMP content
  80. 80. Efficient document workflow
  81. 81. Centrally and readily retrievable VMPs
  82. 82. Paperlesscompliance
  83. 83. According Eudralex volume 4 annex 15
  84. 84. 21 CFR part 11 and annex 11 compliant</li></ul>www.rescop.com<br />27<br />www.rescop.com<br />27<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  85. 85. www.rescop.com<br />28<br />RC-VMP<br />www.rescop.com<br />28<br />www.rescop.com<br />28<br />www.rescop.com<br />28<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  86. 86. www.rescop.com<br />29<br />RC-VMP<br />www.rescop.com<br />29<br />www.rescop.com<br />29<br />www.rescop.com<br />29<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  87. 87. www.rescop.com<br />30<br />Objective of RC-SDLC<br />Manage and support development, engineering, implementation, validation, qualification and commissioning of automated systems to ensure compliance with GxP-regulations and company procedures.<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  88. 88. www.rescop.com<br />31<br />Main functionality of RC-SDLC<br /><ul><li>Integrated Project Management
  89. 89. Generateanappropriatevalidation/qualification/commissioningapproach for a given system, based on configurable workflow
  90. 90. Integrated Risk Management
  91. 91. Dashboard providing an overview on the validation/qualification/ commissioning process and access to the corresponding documents
  92. 92. Content management, incl. integrated requirement and test management
  93. 93. Automated workflow for generation, review and approval of documents</li></ul>www.rescop.com<br />31<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  94. 94. www.rescop.com<br />32<br />Main functionality of RC-SDLC - continued<br /><ul><li>Libraryfordefinition and inheritance of defaultrequirements and test scripts
  95. 95. Design Assistance
  96. 96. View documents of similar systems
  97. 97. Import requirements and test scripts from existing documentationorlibrary
  98. 98. SupplierAssessment & Selection
  99. 99. AutomatedTraceability Matrix
  100. 100. Test registration (incl. documented evidence) and defect handling
  101. 101. Change Control, incl. version management for software
  102. 102. Management Reporting</li></ul>www.rescop.com<br />32<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  103. 103. www.rescop.com<br />33<br />Advantages of RC-SDLC<br /><ul><li>GxP compliant validation/qualification/commissioning
  104. 104. Centrally and readily retrievable documentation
  105. 105. Efficient document review and approval through automated workflow
  106. 106. Consistent and adequate validation/qualification/commissioning through standardization of approach, documentation and content
  107. 107. Speeding up of the validation/qualification/ commissioningprocessthroughreuse of content
  108. 108. Paperlesscompliance
  109. 109. 21 CFR part 11 and annex 11 compliant</li></ul>www.rescop.com<br />33<br />www.rescop.com<br />33<br />www.rescop.com<br />33<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  110. 110. www.rescop.com<br />34<br />RC-SDLC<br />www.rescop.com<br />34<br />www.rescop.com<br />34<br />www.rescop.com<br />34<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  111. 111. www.rescop.com<br />35<br />RC-SDLC<br />RC-SDLC<br />www.rescop.com<br />35<br />www.rescop.com<br />35<br />www.rescop.com<br />35<br />www.rescop.com<br />35<br />www.rescop.com<br />35<br />www.rescop.com<br />35<br />www.rescop.com<br />35<br />Rescop–Challenges -Introduction RC-ECMS – Advantages - Pricing<br />Rescop–Challenges -Introduction RC-ECMS – Advantages - Pricing<br />
  112. 112. www.rescop.com<br />36<br />RC-SDLC<br />RC-SDLC<br />www.rescop.com<br />36<br />www.rescop.com<br />36<br />www.rescop.com<br />36<br />www.rescop.com<br />36<br />www.rescop.com<br />36<br />www.rescop.com<br />36<br />www.rescop.com<br />36<br />www.rescop.com<br />36<br />Rescop–Challenges -Introduction RC-ECMS – Advantages - Pricing<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  113. 113. Objective of RC-ECMS<br />Control, support and integrate all processes required for GxP compliance of automatedsystems.<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  114. 114. www.rescop.com<br />38<br />Main functionality of RC-ECMS<br />Products are available per automated system compliance process, which has the following advantages:<br /><ul><li>Automated system compliance processes can be integrated to improve efficiency;
  115. 115. Integration and automation of the variousprocessesenablespaperlesscompliance;</li></ul>www.rescop.com<br />38<br />www.rescop.com<br />38<br />www.rescop.com<br />38<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  116. 116. www.rescop.com<br />39<br />Main functionality of RC-ECMS - continued<br /><ul><li>The system can be integrated with any existing systems within the company that are involved in automatedsystem compliance;
  117. 117. The various products allow for a phased roll-out of the system.</li></ul>Each product can be configured according the company’s compliance approach and needs.<br />www.rescop.com<br />39<br />www.rescop.com<br />39<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  118. 118. RC-ECMS diagram<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  119. 119. www.rescop.com<br />41<br />Advantages of RC-ECMS<br />Inspectionreadiness:<br /><ul><li>Traceability through automated linking of activities, deliverables and content
  120. 120. Consistent and adequate execution of compliance processes through standardization of approach, documentation and content
  121. 121. Centrally and readily retrievable documentation
  122. 122. Management reporting</li></ul>www.rescop.com<br />41<br />www.rescop.com<br />41<br />www.rescop.com<br />41<br />www.rescop.com<br />41<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  123. 123. www.rescop.com<br />42<br />Advantages of RC-ECMS - continued<br />Efficientcomplianceprocesses:<br /><ul><li>Automated workflow for review and approval
  124. 124. Integration of complianceprocesses
  125. 125. Re-use of deliverables and content
  126. 126. Risk-based approach and decision mechanism
  127. 127. Central point for storing and sharing compliance documentation and knowledge</li></ul>Paperlesscompliance<br />21 CFR part 11 and annex 11 compliant<br />www.rescop.com<br />42<br />www.rescop.com<br />42<br />www.rescop.com<br />42<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  128. 128. www.rescop.com<br />43<br />RC-ECMS<br />www.rescop.com<br />43<br />www.rescop.com<br />43<br />www.rescop.com<br />43<br />www.rescop.com<br />43<br />www.rescop.com<br />43<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  129. 129. www.rescop.com<br />44<br />RC-ECMS<br />www.rescop.com<br />44<br />www.rescop.com<br />44<br />www.rescop.com<br />44<br />www.rescop.com<br />44<br />www.rescop.com<br />44<br />Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS<br />
  130. 130. Compliance software can be purchased <br />and is available as software as a service<br />For more information, please feel free to send your email to: info@rescop.com<br />Or visit our website: www.rescop.com<br />

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