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1. Setup New Projects
1. Setup New Projects
Instructions
Chase Schwalbach
4/28/2022
Assay - Liquid
Pre-Load Line Items for Selection
High Level Phase
Functional Phase
Deliverable
Templates to fill out
Paste in finished template
Responsible Parties (Doing the work)
Accountable (On the hook)
Consulted (Must Sign Off)
Informed
Delete Row / Not Needed
Scoping and Research, Feasibility and Planning
33
Assay Definition
3
Product Initiation Questionaire Completed
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Initial Intended Use Draft
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Initial Design Requirements Draft
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Scoping
8
DDP Completed
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Research and WL development plant
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Regulatory Plan Complete
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Quality Plan Complete
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SW development plan drafted
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Risk Managment Plan Complete (IVD only)
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Product/Eng Development Plan Draft
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Customize General project deliverable checklist for project complete
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Project Management
5
Key stakeholders Identified
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Project Teams Assigned
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Coda(Research) / Algos Grid / Engineering / Other projects launched
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Recurring team meetings scheduled
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Customize General project deliverable checklist for project complete
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Feasability Assessment
8
Finalized Intended Use Approved
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Finalized Design Requirements Approved
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Finalized Commercial Requirements Approved
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Finalized Operational Requirements Approved
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Finalized Other Scientific Objectives Approved
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Complete Scientific Risk Assessment (algo tool)
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Initial feasibility assessment complete/reported if applicable
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Impact Assessments (Regulatory, Operational, Business, Product/Eng)
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Marketing Assessment
4
Competative Landscape and Market Assessement Complete
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KOL assessments complete
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Marketing Plan Draft/Complete?
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Sales Strategy Draft
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Operational Assessement
5
Automation Strategy Draft
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Clinical Staffing Plan Draft
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Capital Equiptment Plan
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LAB SPACE AND CAPCITY PLAN?
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Data Storage Capacity Plan?
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Assay Development
19
Assay Development and Optimization
19
Assay Chemsitries Finalized
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Writing of Clinical Workflow SOPs (including equipment, reagents, batch records, checklists)
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Reagent passing criteria defined
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Assay WL/Automation process Finalized
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QC Materials Selected and Requirements Defined
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QC thresholds established from minimum of 3 runs or lots as applicable (QC, Controls, etc)
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QC handling process finalized (e.g aliquoting of positive controls)
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Equipment List Defined
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Facility layout updated and utilities installed
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Equipment Purchased / Allocated
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Automation Scripts Finalized in Github
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Analytical Pipeline Built / Trained
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Analytical Pipeline Trained
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Initial Validation Plan Draft
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Critical targets list from Medical Complete
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dFMEA (IVD only)
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sFMEA (IVD only)
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Demonstrate concordance across all instruments/analyzers
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Competencies built
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Assay Transfer
29
Assay Transfer
29
E2E Map Completed
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Clinical Workflow SOPs approved (including equipment, reagents, batch records, checklists)
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All reagent lots to be phased in provided to QC
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pFMEA (IVD only)
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LIMS/LAMs builds complete
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OPUS build complete
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Orderhub build complete
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Other
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E2E of engineering systems Complete
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BOM / Reagents Complete
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Netsuite setup all items complete
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Netsuite Forecasts Complete
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Supply Dashboard?
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Supplier Approvals Completed
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Supplier Agreements in Place
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Supplier WI SOPs finalized (eg IDT probe formluation)
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Cost Sheets Finalized
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Supplies ordered
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Clinical Staffing Plan Complete
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Clinical and QC Staff Training Completed (including equipment use/maintenance)
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Clinical Staff Compentencies Completed
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IQ/OP/PQ all Equipment and creation of maintenance logs
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IQ/OP/PQ all Automation Scripts/Methods
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Min 1 (prefered 3) manf lots phased in / min 3 month post lauch supply (preferred 6 mo)
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QC Material Requirements Documented and Approved
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Validation plan approved
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Process Verifications Completed
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All Change Control Complete
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DMR Draft (IVD only)
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Validation
12
Validation
12
Analytical Validation Report Complete
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Marketing Data / Materials Finalized
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Sell Sheet Completed
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Validation 1 Pager Compelted
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Branded Reports completed
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Sales/MA/Other FAQ Completed
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Website Draft Completed
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Report gen Draft/Mocks Complete
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End to End Run Successful (Operational Validation Complete - Part of Validation)
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Close out remaining training items
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Transfer all R&D reagents to Clinical Inventory Completed
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Launch
24
Launch
24
Report gen Builds complete
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Portal and Mobile
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Customer Interface - Ordering Build Complete
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Customer Interface - Portal Build Complete
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Customer Interface - Mobile Build Complete
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EMR Integration Sign off
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OPUS UAT complete
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LIMS UAT complete
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Engineering Validation Report Approved?
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Clinical Team Sheets Final
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Sales Stragey Finalized
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Sales Team Trained
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Website Completed
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Other deliverables
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Accessioning Team Trained
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Returns Team Trained
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Order Processing Traiing (Zendesk and Lab) Complete
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Anything to register with CAP/NYS/MOLDX?
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Post Launch
2
Post Launch
2
Incorporate new common deliverables back into general sheet
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Lessons learned review
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