1. MOFFITT CANCER CENTER Cell Therapy Facility
EXPERIENCE IMPLEMENTING A QUALITY MANAGEMENT SOFTWARE SYSTEM
November 13, 2017
ASQ Tampa/St Petersburg Section

2. OUTLINE
Background
Our need
Vision
Project plan
Milestones
Future

3. Moffitt Cancer Center (30 years)
MISSION: To contribute to the prevention and cure of cancer VISION: To transform cancer care through service, science and partnership
Only NCI Designated Comprehensive Cancer Center in Florida

4. Moffitt Cancer Center
Research Institute
Hospital
Clinic

5. Cell Therapy Facility

6. Cell Therapy Facility

7. Cell Therapy Facility
Cellular therapy (CT) is the transplantation of human cells to replace or repair damaged tissue and/or cells.
Some of the cells that may be used include hematopoietic (blood-forming) progenitor cells (HPC), skeletal muscle stem cells, mesenchymal stem cells, lymphocytes, dendritic cells, and pancreatic islet cells.

8. Cell Therapy Facility
HPC used for Blood and Marrow transplants treating hematologic malignancies.

9. Cell Therapy Facility
Experimental Cell Therapies using dendritic cells, autologous tumor cells, T Cells to stimulate immune response to cancer cells.

10. VOLUMES

11. Increasing Requirements

12. The Catch-up Game

13. Making our case
Pilot –Potential enterprise expansion

14. Search for solution
Competitor

15. Modules Purchased Audits Documents Training Risk QEM
Internal and External Audits
Planning, Resources, Findings, Responses, CAPAs, Reports
Documents
Training
QEM
Risk
Audits
All controlled documents
Creation-Collaboration, Organization, Archival, Approval (e-signature)
All Training – Competency - Retraining
Based on written procedures, extra materials, class scheduling, documentation, reports.
Quality Event Monitoring
Incident/Deviation/Complaint Reporting, CAPA
Equipment Maintenance/Calibration

16. Modules Purchased - Phases
Phase I – Document Control, Training Modules

17. Modules Purchased - Phases
Phase II – Quality Event Management (QEM)
Incident Report
Deviations
Out of Specification
CAPA essentials
Non-conformance
Equipment Maintenance
Equipment Calibration
Change Control advanced

18. Project Initiation – Phase I
Internal Project Manager from IT and CTF appointed to work with the vendor’s Project Manager.
Administrator (champion) from each department were identified.
Document Control was identified as the most critical need of the laboratories and implemented concurrently with the training module.
Remote installation of the system involved several sessions with a member of the vendor installing team, and the internal IT Project Manager.

19. Configuration
After training, administrators identified the user requirements in a series of meetings with the Subject Matter Experts (SMEs) for each department, reaching consensus for the configuration and customization.
Configuration was accomplished through a series of on-site collaborative sessions between a vendor representative, the internal administrators and the internal IT Project Manager.

21. Validation – Phase I
Installation Qualification was performed by the vendor during installation sessions.
Validation plan and protocols for IQ and PQ were provided by the vendor and reviewed, revised and approved by the laboratory team prior to execution.
The vendor provided a Transfer Operational Qualification (TOQ) covering all aspects of the software.
TOQ was extensively reviewed with the internal team through several remote meetings.

22. Validation – Phase I
A risk assessment was performed remotely between the vendor and the internal team, to refine the needs of the PQ and documented in the Risk Management Plan.
PQ was performed following the Risk Management Plan and using the most complex processes rather than going through every single case scenario. This strategy saved time and resources while testing all functionality of the software as configured for the laboratories’ needs.

23. Implementation – Phase I
The first phase of implementation of the software went live in August 2015.
Validation and implementation of the first phase of the QMSS took 1 dedicated FTE (50% of each department’s administrator) and significant involvement of an IT representative.
Documents are continuously created, approved and archived.
Time from document revision to approval has been reduced considerably and allows for expedited approval of documents to meet unexpected deadlines, such as accreditation inspections, IND submissions and grant proposals.

24. Implementation – Phase I
Activity
Vendor services (hrs.)
Internal staff effort (hrs.)
Education 56 96
Installation 14
Configuration 84
440
Validation 80 73
Initial End User Training 16 20
Total initial effort
250
643

25. Status at Go-Live Phase I
Document Type
Tissue Core (TC)
Cellular Therapies (CTF)
Policies 47 35
Procedures
132
220
Processes 3
Forms 30
240
Labels 16
Validations 31
Protocols 2
Competency Assessments
Templates 13 6
Totals
551

26. Implementation – Phase II
QEM Module – Out of the box
Customization available
Moffitt Purchased 6 custom forms.
Incident Report
Deviations
Out of Specification
CAPA essentials
Non-conformance
Equipment Maintenance
Equipment Calibration
Change Control advanced

27. Implementation – Phase II
Agile Style Project Schedule
Less configuration activities
Less flexibility*
More independent learning
Remote collaboration
Remote Validation
*This may be a positive

28. Implementation – Phase II
CTF Implemented Change Control advanced
TC Implemented Equipment Maintenance and Calibration
All Custom forms validated – Remote sessions
Currently Developing Standard Operating Procedures for implementation of custom forms

29. Lessons learned
Critical to the success of this implementation was to have an approved plan in place to manage the financial and human resources.
Also critical was the identification of departmental champions who managed the project. These champions should have enough time available to dedicate to the project
Involvement of a knowledgeable internal IT Project Manager is essential to the success of the implementation.
The vendors of the system provide expertise for validation activities. Investing financial resources to purchase these services allows the internal staff to focus on optimizing the performance of the system.
Interactions of the system with other existing software and institutional security measures can complicate the installation and proper functioning of the software.

30. CONCLUSIONS
The implementation of a validated QMSS can be achieved with the investment of human and financial resources.
The division of the implementation in phases has been beneficial to the facility as it allowed for a sense of accomplishment at each stage, rapid improvement of current systems and compartmentalization of the validation.
It is essential to ensure resources are available for all phases of the project.