More Related Content Similar to Presentation compliance software events and internet en Similar to Presentation compliance software events and internet en (20) Presentation compliance software events and internet en2. 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 10. Configurable roles and rightswww.rescop.com 6 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS 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 24. change control, in accordance with GxP regulations. Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS 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 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 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 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 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 91. Dashboard providing an overview on the validation/qualification/ commissioning process and access to the corresponding documents 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 106. Consistent and adequate validation/qualification/commissioning through standardization of approach, documentation and content 107. Speeding up of the validation/qualification/ commissioningprocessthroughreuse of content 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 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 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