More Related Content Similar to Presentation Compliance Software Events And Internet En Similar to Presentation Compliance Software Events And Internet En (20) 2. Rescop B.V. – Regulatory System Compliance Partners Innovative solutions for GxP compliance of automated systems, 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: [email_address] 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 www.rescop.com Compliance Software RC-DMS Document Management System RC-CAPA Deviation Handling, CAPA and Change Control RC-CMDB Asset & Configuration Management RC-VMP Validation Master Planning RC-Logbook Scheduling & Logging RC-SDLC Validation, Qualification and Commissioning RC-ECMS Enterprise Compliance Management Suite Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS 5. www.rescop.com Objective of RC-DMS Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS Store, manage and publish quality documentation (e.g. SOPs, validation documentation, etc.) in accordance with GxP regulations. 15. www.rescop.com Objective of RC-CMDB Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS Maintain a registration of automated systems, their status and their configuration. 25. www.rescop.com Objective of RC-VMP Generate and manage site / departmental Validation Master Plans according Eudralex volume 4 Annex 15 requirements . Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS 29. Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS www.rescop.com www.rescop.com www.rescop.com www.rescop.com RC-VMP Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS 30. www.rescop.com Objective of RC-SDLC Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS Manage and support development, engineering, implementation, validation, qualification and commissioning of automated systems to ensure compliance with GxP-regulations and company procedures. 35. www.rescop.com www.rescop.com www.rescop.com www.rescop.com RC-SDLC Rescop – Challenges - Introduction RC-ECMS – Advantages - Pricing www.rescop.com www.rescop.com www.rescop.com www.rescop.com RC-SDLC Rescop – Challenges - Introduction RC-ECMS – Advantages - Pricing 36. www.rescop.com www.rescop.com www.rescop.com www.rescop.com www.rescop.com RC-SDLC Rescop – Challenges - Introduction RC-ECMS – Advantages - Pricing www.rescop.com www.rescop.com www.rescop.com www.rescop.com RC-SDLC Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS 37. Objective of RC-ECMS Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS Control, support and integrate all processes required for GxP compliance of automated systems. 40. RC-ECMS diagram Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS 45. Compliance software can be purchased and is available as software as a service For more information, please feel free to send your email to: [email_address] Or visit our website: www.rescop.com
![Rescop B.V. – Regulatory System Compliance Partners Innovative solutions for GxP compliance of automated systems, 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: [email_address] www.rescop.com](data:image/gif;base64,R0lGODlhAQABAIAAAAAAAP///yH5BAEAAAAALAAAAAABAAEAAAIBRAA7)