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

OUTLINE Background Our need Vision Project plan Milestones Future

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

Moffitt Cancer Center Research Institute Hospital Clinic

Cell Therapy Facility

Cell Therapy Facility

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.

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

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

VOLUMES

Increasing Requirements

The Catch-up Game

Making our case Pilot –Potential enterprise expansion

Search for solution Competitor

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

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

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

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.

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.

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.

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.

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.

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

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

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

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

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

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.

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.