Presentation Compliance Software Events And Internet En

521 views

Published on

0 Comments
0 Likes
Statistics
Notes
  • Be the first to comment

  • Be the first to like this

No Downloads
Views
Total views
521
On SlideShare
0
From Embeds
0
Number of Embeds
1
Actions
Shares
0
Downloads
0
Comments
0
Likes
0
Embeds 0
No embeds

No notes for slide

Presentation Compliance Software Events And Internet En

  1. 1. www.rescop.com 1 Regulatory System Compliance Partners
  2. 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: info@rescop.com www.rescop.com
  3. 3. www.rescop.com 4www.rescop.com 4 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
  4. 4. www.rescop.com 5 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.
  5. 5. www.rescop.com 6www.rescop.com 6 Main functionality of RC-DMS  Uploading of documents with common file types and generation of .pdf versions  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 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  6. 6. www.rescop.com 7www.rescop.com 7 Main functionality of RC-DMS - continued  User interface depending on roles and rights  Version Management  Schedule and trigger periodic review of documents  Possibility to print authentic copies  Management Reporting Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  7. 7. www.rescop.com 8www.rescop.com 8www.rescop.com 8 Advantages of RC-DMS Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS  GxP compliant document management  Standardized and efficient document workflow  Centrally and readily retrievable documentation  Paperless compliance  21 CFR part 11 and annex 11 compliant
  8. 8. www.rescop.com 9www.rescop.com 9 RC-DMS
  9. 9. www.rescop.com 10 Objective of RC-CAPA Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS Manage and support:  handling of deviations, complaints, audit observations, etc.  registration and monitoring of corrective and preventive actions  change control , in accordance with GxP regulations.
  10. 10. www.rescop.com 11www.rescop.com 11 Main functionality of RC-CAPA  Register and handle CAPA cases: a) Case Initiation, incl. source (deviation, complaint, audit observation, etc.) and affected process b) Risk Assessment c) Root Cause Investigation d) Proposed Mitigation Actions (corrective and preventive), incl. link to change e) Results of Mitigation Actions f) Closure Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  11. 11. www.rescop.com 12www.rescop.com 12 Main functionality of RC-CAPA - continued  Register and handle Change Requests  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 Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  12. 12. www.rescop.com 13www.rescop.com 13www.rescop.com 13www.rescop.com 13 Advantages of RC-CAPA Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS  GxP compliant Deviation Handling, Corrective & Preventive Actions and Change Control  Centrally and readily retrievable deviations, corrective and preventive actions and changes  Consistent Deviation Handling, Corrective & Preventive Actions and Change Control processes through standardization of approach and content  Efficient review and approval through automated workflow  Paperless compliance  Traceability of all open and closed activities  21 CFR part 11 and annex 11 compliant
  13. 13. www.rescop.com 14www.rescop.com 14 RC-CAPA Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  14. 14. www.rescop.com 15 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.
  15. 15. www.rescop.com 16www.rescop.com 16 Main functionality of RC-CMDB Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS  Register automated systems, incl. use- and compliance status  Configurable system overviews  Register system components, incl. hardware, software, equipment, documentation and users  Baseline reporting  Supplier management  Management reporting
  16. 16. www.rescop.com 17www.rescop.com 17www.rescop.com 17 Advantages of RC-CMDB Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS  GxP compliant system overviews  In control through an overview on the company’s systems and their compliance status  Full traceability of all configuration changes during the total lifecycle of the system.  21 CFR part 11 and annex 11 compliant
  17. 17. www.rescop.com 18www.rescop.com 18 RC-CMDB Rescop – Challenges - Introduction RC-ECMS – Advantages - Pricing
  18. 18. www.rescop.com 19www.rescop.com 19 RC-CMDB
  19. 19. www.rescop.com 20 Objective of RC-Logbook Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS  Schedule and trigger maintenance, management and use of automated systems.  Register incidents, management and use of automated systems in a GxP compliant electronic logbook.
  20. 20. www.rescop.com 21www.rescop.com 21 Main functionality of RC-Logbook Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS  Scheduling of activities  Automated generation and assignment of tasks  Notifications and alerts (incl. escalation) by email  Registration of activities in electronic logbook  Approval of results  Definition of default activity recurrences and frequencies per system type  Trend reporting  Management reporting
  21. 21. www.rescop.com 22www.rescop.com 22www.rescop.com 22 Advantages of RC-Logbook Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS  Inspection readiness through scheduling and automated generation of tasks (incl. notifications and alerts)  Centrally and readily retrievable logbooks  Standardisation of logbook information  Consistency through definition of default activity recurrences and frequencies per system type  Paperless compliance  21 CFR part 11 and annex 11 compliant
  22. 22. www.rescop.com 23www.rescop.com 23www.rescop.com 23www.rescop.com 23 RC-Logbook Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  23. 23. www.rescop.com 24www.rescop.com 24www.rescop.com 24www.rescop.com 24www.rescop.com 24 RC-Logbook Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  24. 24. www.rescop.com 25 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
  25. 25. www.rescop.com 26www.rescop.com 26 Main functionality of RC-VMP Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS  Create, generate and maintain VMP content  Generate, review and approve VMP documents  Publish and search for VMPs  Scheduling and triggering of periodic VMP updates  Management reporting
  26. 26. www.rescop.com 27www.rescop.com 27www.rescop.com 27 Advantages of RC-VMP Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS  GxP compliant VMPs  Standardization of VMP content  Efficient document workflow  Centrally and readily retrievable VMPs  Paperless compliance  According Eudralex volume 4 annex 15  21 CFR part 11 and annex 11 compliant
  27. 27. www.rescop.com 28www.rescop.com 28www.rescop.com 28www.rescop.com 28 RC-VMP Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  28. 28. Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS www.rescop.com 29www.rescop.com 29www.rescop.com 29www.rescop.com 29 RC-VMP Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  29. 29. www.rescop.com 30 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.
  30. 30. www.rescop.com 31www.rescop.com 31 Main functionality of RC-SDLC  Integrated Project Management  Generate an appropriate validation/qualification/commissioning approach for a given system, based on configurable workflow  Integrated Risk Management  Dashboard providing an overview on the validation/qualification/ commissioning process and access to the corresponding documents  Content management, incl. integrated requirement and test management  Automated workflow for generation, review and approval of documents Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  31. 31. www.rescop.com 32www.rescop.com 32 Main functionality of RC-SDLC - continued  Library for definition and inheritance of default requirements and test scripts  Design Assistance  View documents of similar systems  Import requirements and test scripts from existing documentation or library  Supplier Assessment & Selection  Automated Traceability Matrix  Test registration (incl. documented evidence) and defect handling  Change Control, incl. version management for software  Management Reporting Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  32. 32. www.rescop.com 33www.rescop.com 33www.rescop.com 33www.rescop.com 33 Advantages of RC-SDLC  GxP compliant validation/qualification/commissioning  Centrally and readily retrievable documentation  Efficient document review and approval through automated workflow  Consistent and adequate validation/qualification/commissioning through standardization of approach, documentation and content  Speeding up of the validation/qualification/ commissioning process through reuse of content  Paperless compliance  21 CFR part 11 and annex 11 compliant Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  33. 33. www.rescop.com 34www.rescop.com 34www.rescop.com 34www.rescop.com 34 RC-SDLC Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  34. 34. www.rescop.com 35www.rescop.com 35www.rescop.com 35www.rescop.com 35 RC-SDLC Rescop – Challenges - Introduction RC-ECMS – Advantages - Pricing www.rescop.com 35www.rescop.com 35www.rescop.com 35www.rescop.com 35 RC-SDLC Rescop – Challenges - Introduction RC-ECMS – Advantages - Pricing
  35. 35. www.rescop.com 36www.rescop.com 36www.rescop.com 36www.rescop.com 36www.rescop.com 36 RC-SDLC Rescop – Challenges - Introduction RC-ECMS – Advantages - Pricing www.rescop.com 36www.rescop.com 36www.rescop.com 36www.rescop.com 36 RC-SDLC Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  36. 36. 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.
  37. 37. www.rescop.com 38www.rescop.com 38www.rescop.com 38www.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;  Integration and automation of the various processes enables paperless compliance; Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  38. 38. www.rescop.com 39www.rescop.com 39www.rescop.com 39 Main functionality of RC-ECMS - continued Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS  The system can be integrated with any existing systems within the company that are involved in automatedsystem compliance;  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.
  39. 39. RC-ECMS diagram Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  40. 40. www.rescop.com 41www.rescop.com 41www.rescop.com 41www.rescop.com 41www.rescop.com 41 Advantages of RC-ECMS Inspection readiness:  Traceability through automated linking of activities, deliverables and content  Consistent and adequate execution of compliance processes through standardization of approach, documentation and content  Centrally and readily retrievable documentation  Management reporting Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  41. 41. www.rescop.com 42www.rescop.com 42www.rescop.com 42www.rescop.com 42 Advantages of RC-ECMS - continued Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS Efficient compliance processes:  Automated workflow for review and approval  Integration of compliance processes  Re-use of deliverables and content  Risk-based approach and decision mechanism  Central point for storing and sharing compliance documentation and knowledge Paperless compliance 21 CFR part 11 and annex 11 compliant
  42. 42. www.rescop.com 43www.rescop.com 43www.rescop.com 43www.rescop.com 43www.rescop.com 43www.rescop.com 43 RC-ECMS Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  43. 43. www.rescop.com 44www.rescop.com 44www.rescop.com 44www.rescop.com 44www.rescop.com 44www.rescop.com 44 RC-ECMS Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  44. 44. 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

×