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Timelining Defaults
Timelining Defaults
High level Phase
Functional Phases
Deliverable
Dependent Upon Anything?
Scoping and Research, Feasibility and Planning
33
Assay Definition
3
Product Initiation Questionaire Completed
Initial Intended Use Draft
Initial Design Requirements Draft
Scoping
8
DDP Completed
Research and WL development plant
Regulatory Plan Complete
Quality Plan Complete
SW development plan drafted
Risk Managment Plan Complete (IVD only)
Product/Eng Development Plan Draft
Customize General project deliverable checklist for project complete
Project Management
5
Key stakeholders Identified
Project Teams Assigned
Coda(Research) / Algos Grid / Engineering / Other projects launched
Recurring team meetings scheduled
Customize General project deliverable checklist for project complete
Feasability Assessment
8
Finalized Intended Use Approved
Finalized Design Requirements Approved
Finalized Commercial Requirements Approved
Finalized Operational Requirements Approved
Finalized Other Scientific Objectives Approved
Complete Scientific Risk Assessment (algo tool)
Initial feasibility assessment complete/reported if applicable
Impact Assessments (Regulatory, Operational, Business, Product/Eng)
Marketing Assessment
4
Competative Landscape and Market Assessement Complete
KOL assessments complete
Marketing Plan Draft/Complete?
Sales Strategy Draft
Operational Assessement
5
Automation Strategy Draft
Clinical Staffing Plan Draft
Capital Equiptment Plan
LAB SPACE AND CAPCITY PLAN?
Data Storage Capacity Plan?
Assay Development
19
Assay Development and Optimization
19
Assay Chemsitries Finalized
Writing of Clinical Workflow SOPs (including equipment, reagents, batch records, checklists)
Reagent passing criteria defined
Assay WL/Automation process Finalized
QC Materials Selected and Requirements Defined
QC thresholds established from minimum of 3 runs or lots as applicable (QC, Controls, etc)
QC handling process finalized (e.g aliquoting of positive controls)
Equipment List Defined
Facility layout updated and utilities installed
Equipment Purchased / Allocated
Automation Scripts Finalized in Github
Analytical Pipeline Built / Trained
Analytical Pipeline Trained
Initial Validation Plan Draft
Critical targets list from Medical Complete
dFMEA (IVD only)
sFMEA (IVD only)
Demonstrate concordance across all instruments/analyzers
Competencies built
Assay Transfer
29
Assay Transfer
29
E2E Map Completed
Clinical Workflow SOPs approved (including equipment, reagents, batch records, checklists)
All reagent lots to be phased in provided to QC
pFMEA (IVD only)
LIMS/LAMs builds complete
OPUS build complete
Orderhub build complete
Other
E2E of engineering systems Complete
BOM / Reagents Complete
Netsuite setup all items complete
Netsuite Forecasts Complete
Supply Dashboard?
Supplier Approvals Completed
Supplier Agreements in Place
Supplier WI SOPs finalized (eg IDT probe formluation)
Cost Sheets Finalized
Supplies ordered
Clinical Staffing Plan Complete
Clinical and QC Staff Training Completed (including equipment use/maintenance)
Clinical Staff Compentencies Completed
IQ/OP/PQ all Equipment and creation of maintenance logs
IQ/OP/PQ all Automation Scripts/Methods
Min 1 (prefered 3) manf lots phased in / min 3 month post lauch supply (preferred 6 mo)
QC Material Requirements Documented and Approved
Validation plan approved
Process Verifications Completed
All Change Control Complete
DMR Draft (IVD only)
Validation
12
Validation
12
Analytical Validation Report Complete
Marketing Data / Materials Finalized
Sell Sheet Completed
Validation 1 Pager Compelted
Branded Reports completed
Sales/MA/Other FAQ Completed
Website Draft Completed
Report gen Draft/Mocks Complete
End to End Run Successful (Operational Validation Complete - Part of Validation)
Close out remaining training items
Transfer all R&D reagents to Clinical Inventory Completed
Launch
24
Launch
24
Report gen Builds complete
Portal and Mobile
Customer Interface - Ordering Build Complete
Customer Interface - Portal Build Complete
Customer Interface - Mobile Build Complete
EMR Integration Sign off
OPUS UAT complete
LIMS UAT complete
Engineering Validation Report Approved?
Clinical Team Sheets Final
Sales Stragey Finalized
Sales Team Trained
Website Completed
Other deliverables
Accessioning Team Trained
Returns Team Trained
Order Processing Traiing (Zendesk and Lab) Complete
Anything to register with CAP/NYS/MOLDX?
Post Launch
2
Post Launch
2
Incorporate new common deliverables back into general sheet
Lessons learned review
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