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
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
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
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
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
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.
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