Implementing an e-validation Solution at Myriad Genetics

Transcription

1 Implementing an e-validation Solution at Myriad Genetics 1

2 Slide Index Company Background Business Drivers for an e-validation Solution Alternatives Considered Key requirements Assessment Implementation Strategy Solution Implementation Process Results Outcomes Next Steps Recommendations/Lessons Learned 2

3 Company Background Founded in years before the human genome was sequenced - making Myriad one of the first genomics companies in history Today, Myriad is the pioneer and leader in molecular diagnostics, offering innovative products that transform patients lives Leading molecular diagnostic tests for hereditary cancer, urological cancer, lung cancer, autoimmune disorders and other diseases. Assess an individual s risk for developing disease so that action can be taken to prevent or delay its onset 3

4 Company Background Our diagnostic tests help in the early and accurate diagnosis of disease, when it is more treatable and survival rates are better. Our prognostic medicine products assess a patient s risk of disease progression and recurrence, so that a healthcare professional knows how aggressively to treat the disease. Our companion diagnostic products identify a patient s likelihood of responding to a particular therapy to ensure optimal treatment decisions. Myriad successfully completed the first PMA FDA approved Laboratory Developed Test (LDT) as a companion diagnostic. 4

5 Business Drivers for e-validation Existing paper based validation process for most validation types (process, cleaning, equipment, facilities) Needed to develop and implement a Computer System Validation process/program The culture at Myriad is computer based system focused In creating a new Computer System Validation process, it was the focus to steer away from the pitfalls of paper based systems. GDP Errors Lost Documents Approval routing issues Archival space It was imperative to have a functional, user friendly system that supports process retrieval and viewing of records that fit company culture 5

6 Alternatives Considered 1. Implement a Paper Based Validation process 2. Implement a hybrid Validation Process (combination of paper and e-document Management solution) 3. Implement an e-validation Solution process 6

7 Key Requirements Select and implement an e-validation solution for Computer system validation as first priority Reason - new CSV process to mirror the evolved electronic based culture that Myriad employees are used to A system that is process centric not tool centric e-validation solution should not drive the process Our procedures drive the process not the tool 7

8 Assessment Process 4 e-validation solutions identified and assessed against user requirements 2 solutions selected for trial/pilot 1 solution selected based on: user feedback for functionality ease of use adaptability to future business process needs (configurable) and traditional feel 8

9 Implementation Strategy Start with the new CSV Category 3 Off the Shelf process Custom Framework soon followed Rest of the CSV categories (Infrastructure, Automation, Custom, and Scripts) All new QMS processes created after this point would be controlled electronically (Change Control, Complaints etc) Because of the PMA elevated timeline, implementation of the Computer System Validation process and e-validation tool was performed simultaneously. Procedures were written to be tool agnostic but templates are controlled electronically Additional existing Validation processes will be implemented based on business priorities 9

10 Solution Implementation Process Project charter and schedule established Project Steering Committee and Team established Vendor support services contract established Project Goals and key milestones established Application support SME trained on new e-val Solution tool Business process and procedures documented E-Val Solution validated and deployed 10

11 Results Myriad e-val Solution went live globally in September User feedback and Reported Results: 100% paperless process for CSV - Computer Systems and Automation Streamlined our work processes Consolidated and aligned the validation process steps making framework scalable More efficient and effective at meeting the increasing compliance and efficiency demands of the business External regulatory audits have provided complimentary feedback for innovation and compliance assurance 11

12 Results more detail Realized gains in: overall cycle time reduction work efforts to complete validations validation status and document visibility real time protocol review/comment reconciliation overall consolidation of documentation Validation information, approvals, and documents are readily accessible 24x7 using web browser access Same look and feel as traditional validation Other functions have seen the capability of the Solution and we are exploring its use in these functions 12

13 Next Steps/Objectives Implement all paper based validation processes into our e-validation system Maintain the Software Validation Lifecycle SDLC (Complete) Automation (90%) Process Validation Laboratory equipment Verification Expanding the tool to other sites 13

14 Recommendations/Lessons Learned Don t let perfect get in the way of good. Process driven vs Tool driven FDA reviewed many validation (stories) that were done in our e-validation 14

15 Thank You Questions 15