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www.rescop.com 1
Regulatory System Compliance Partners
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
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
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.
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
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
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
www.rescop.com 9www.rescop.com 9
RC-DMS
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.
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
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
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
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
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.
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
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
www.rescop.com 18www.rescop.com 18
RC-CMDB
Rescop – Challenges - Introduction RC-ECMS – Advantages - Pricing
www.rescop.com 19www.rescop.com 19
RC-CMDB
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.
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
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
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
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
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
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
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
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
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
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.
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
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
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
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
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
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
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.
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
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.
RC-ECMS diagram
Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
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
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
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
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
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

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Presentation Compliance Software Events And Internet En

  • 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. 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. 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. 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. 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. 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
  • 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. 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. 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. 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. 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. 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. 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. 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. www.rescop.com 18www.rescop.com 18 RC-CMDB Rescop – Challenges - Introduction RC-ECMS – Advantages - Pricing
  • 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. RC-ECMS diagram Rescop – Challenges – RC-DMS – RC-CAPA – RC-CMDB – RC-Logbook – RC-VMP – RC-SDLC – RC-ECMS
  • 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. 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. 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. 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. 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