More Related Content 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