Recommended
More Related Content
What's hot
What's hot (20)
Viewers also liked
Viewers also liked (8)
Similar to Fierce Biotech Webinar Mar2015
Similar to Fierce Biotech Webinar Mar2015 (20)
Fierce Biotech Webinar Mar2015
- 2. • Fast growing genetic testing company that develops and commercializes non‐ invasive methods for analyzing DNA • Company Mission: Help families diagnose and manage genetic disease • Building innovative cloud‐ based products for global life sciences industry • Over 200 customers in 80 countries • Company Mission: Customer Success, Employee Success, Speed Companies
- 3. • Disruptive Innovation • Regulation and Innovation • Agile Methodology • Role of EDMS and Selection Process • Document Change Control • Successful Migration • Conclusions Discussion Overview
- 8. • Regulatory Requirements – FDA 21 CFR Part 11 • Esignatures etc. – ISO‐13485 – CAP accreditation – CLIA certification – New York State DOH – IEC‐62304 Regulatory Compliance
- 9. Confidential and Privileged Product Launch Product Launch 9 Design Control Drives New Products to Market Concept Feasibility & Planning Development Validation Rollout & Launch SustainingG1 G2 G3 G4 G5 Idea screen Build business case Try Fail Learn Development Testing & Validation FDA mandates stage‐gate process but no guidance on how that is achieved Feasibility & Planning Gate: Design Review Feasibility & Planning Gate: Design Review Management Go/No Go decision Management Go/No Go decision Development Gate: Design Review Development Gate: Design Review Validation Gate: Design Review Validation Gate: Design Review
- 10. Product Development Characteristics • Put stake in the ground • Cross‐functional iterations • Challenge the results • Rapidly change direction BENEFITS OF AGILE PROCESSES Fail Fast and Learn Allows for Change Early Risk Mitigation Respond Faster Enables Work in Parallel Predictable Results
- 11. Agile/Scrum Methodology Confidential 11 How do we sustain our agility in regulatory environments?
- 13. Design History File Documents Quality Management System (QMS) Deliverable Feasibility and Planning Development Validation Launch Responsible Design History File (DHF) D U U U,C QA Requirements Document D U U C Product Mgmt Specifications document D U U C R&D (Mol Bio, Stats, Biofx, Eng Regulatory Plan D U U C QA Risk Mgmt Plan / Assessment D U U C Product Development Team Design Plan and Key Milestones D U U C Team Lead with Mol Bio, Stats, Biofx, Eng Service and Support Plan D U C Support Traceability Matrix D U C Product Development Team Design Verification Protocol C C C R&D w/ Team Lead, Biofx, Eng Manufacturing Plan D U C Manufacturing Deliverable Feasibility and Planning Development Validation Launch Responsible Sales Forecast D C Sales Marketing Plan D C Marketing Post Market Surveillance D C Customer Support, Produc Transfer Regulatory Notifications and Approvals D C Regulatory Manufacturing Procedures D C Manufacturing Design Validation Protocol D,C C Project Leader w R&D, Biofx, Eng Design Validation Report C C Project Leader w R&D, Biofx, Eng Labeling Plan D C Manufacturing Stability Studies Protocol D,C C Development Stability Studies Report D,C C Development Design Validation Report D,C C Project Leader w R&D, Biofx, Eng Software Verification and Validation Report D,C C Project Leader Supplier Evaluation D,C C Manufacturing Launch Plan D C Product Development Team Manufacturing and Supplier Agreement C Manufacturing, Legal D = Draft U = Update C = Complete
- 14. Regulatory and Quality Assurance Requirements Comments 1. Ease of Use IT requirements, document status and reporting capabilities, dashboards 2. Web‐based Cloud‐based, device agnostic 3. Search Functionality Search by document metadata and full text, saved searches 4. Change Order/Control Iterative version/revision control, workflow management 5. Training Automation Linked to new &/or changed documents, automated calendar retraining scheduling 6. Simultaneous Editing Document review/revision management 7. Security / Access Privileges Legal and IP protections 8. Audit Trails Laboratory focus / CLIA & ISO compliant 9. Integration with Gmail, Okta Automated assignments, reminders 10. FDA 21 CFR Part 11 & HIPPA Compliant Electronic signature support EDMS Requirements (Not Ranked) Regulatory Compliance is Fundamental
- 15. EDMS Vendor Heat Map Developed by Natera Requirements A B C D E Veeva Vault QualityDocs 1 Ease of Use 4 4 3 3 4 5 2 Web‐based 3 4 3 5 5 5 3 Search Functionality 4 3 1 3 3 5 4 Change Order/Control 2.5 2.5 1 1 2.5 4 5 Training Automation 5 3 2 1 5 5 6 Simultaneous Editing 2.5 2 1 4 2 4 7 Security / Access Privileges 3 3 1 2 4 5 8 Audit Trails 5 4 1 1 5 5 9 Integration with Gmail, Okta 3 2 2 4 4 4 10 FDA 21 CFR Part 11 & HIPPA Compliant 5 4 1 2 4 5
- 16. Example of Savings Analysis Average Hourly Creator/Approver Wage $50 $50 n/a TOTAL COST TO MANAGE A DOCUMENT $4,700 $975 Number of New Documents Per Year 100 100 Average Percent Document Revisions Per Year 25% 25% Total Documents Per Year 125 125 ANNUAL COST TO MANAGE ALL DOCUMENTS $587,500 $121,875 Manually (in hours) Automation via Vault (in hours) Percent Savings Note: Numbers are representative and for illustration purposes only. They do not reflect company’s actuals.
- 18. DocumentDocumentDocument Document Change Order Multiple Affected Documents Document Change Order Document Document Document New Revise Withdraw
- 23. Buy‐in From ‐ Executive Team ‐ Cross‐Functional User Group Buy‐in From ‐ Executive Team ‐ Cross‐Functional User Group Mindful Shift in CultureVendor Evaluation Rollout Initial Users 2nd Rollout 3rd Rollout nth Rollout Make it Easy Phased Rollout ‐ Leveraged Vault’s R&U ‐ New group of users per week Accessible Self‐Help Training Clinical Lab Trainers QA Executives ….
- 24. Migration ETL Best Practices Identify Migration approach Document inventory Extract Extract from source(s) Data Mapping Map source / target Review & update data Test Dry run load process Update data as needed Load Execute load Verify migration • Define data to be migrated: core subset, or full data? • Data owners extract and transform • Use a product for extract, transform, and load steps where possible • Create PDF of source audit trail and associate to migrated record • Use reports to verify / document results • Test business processes using migrated records
- 26. • Benefits of Agile for Innovation • Build Agility into the Stage Gate Process • The Right Application Enables Agility in a Highly Regulated Environment – E.g. supports the 34 requirements for electronic signatures – Flexible and Configurable Document Change Control Options Conclusion
- 27. QUESTIONS?
- 28. • Migration and new system • 1. What were you using before? • Answer: We were on paper and tracking documents manually • 2. What was the biggest challenge moving to the new system? • 3. What documents are you managing in the new system? • 4. Were there any other benefits than agility? • Answer: We can mitigate risks ‐ we have visibility into the process e.g. who has not completed their R&U tasks, reduced our compliance risks with detailed audit trails and electronic signatures that are 21 CFR Part 11 compliant • Evaluation • 5. How long did it take to evaluate all the vendors and can you provide some more info on the evaluation process? Was there an RFI (request for information) you used, demos, or POC?