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  • Welcome to your QMS
  • Quality Manual
  • Procedures
    • GP-001 Control of documents
    • GP-002 Quality planning
    • GP-003 Audits
    • GP-004 Vigilance system
    • GP-005 Human Resources and Training
    • GP-006 Non-conformity, Corrective and Preventive actions
    • GP-007 Post-market surveillance
    • GP-008 Product requirements
    • GP-009 Sales
      • Deprecated
      • Templates
      • Specific procedures
        • SP-009-001 How to use the CRM
        • SP-009-002 Contracts
        • SP-009-003 How to share performance metrics
        • Copypasters
        • SP-009-004 Implementation plan helpers
        • SP-009-005 Implementation plan helpers for Clinical Trials
        • SP-009-006 Integration workflow helpers
    • GP-010 Purchases and suppliers evaluation
    • GP-011 Provision of service
    • GP-012 Design, Redesign and Development
    • GP-013 Risk management
    • GP-014 Feedback and complaints
    • GP-015 Clinical evaluation
    • GP-016 Traceability and identification
    • GP-017 Technical assistance service
    • GP-018 Infrastructure and facilities
    • GP-019 Software validation plan
    • GP-020 QMS Data analysis
    • GP-021 Communications
    • GP-022 Document translation
    • GP-023 Change control management
    • GP-024 Cybersecurity
    • GP-025 Usability and Human Factors Engineering
    • GP-027 Corporate Governance
    • GP-050 Data Protection
    • GP-051 Security violations
    • GP-052 Data Privacy Impact Assessment (DPIA)
    • GP-100 Business Continuity (BCP) and Disaster Recovery plans (DRP)
    • GP-101 Information security
    • GP-200 Remote Data Acquisition in Clinical Investigations
    • GP-026 Market-specific product requirements
  • Records
  • Legit.Health Plus Version 1.1.0.0
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
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  • Procedures
  • GP-009 Sales
  • Specific procedures
  • SP-009-004 Implementation plan helpers

SP-009-004 Implementation plan helpers

This is a draft

This document is a draft version.

note

These records are named following the structure:

  • R-009-006 Country code Name of customer YYYYMMDD.
  • Contract sign date: YYYY MM DD (YYYY MM DD)
  • Deal id:

Understand the Customer's Objective​

Goals​

Goals for 1st year​

GoalMetricTarget

Q&A to understand the Customer's objective and requirements​

Project Scope & objectives​

QuestionExpected Answer / InstructionsCustomer's Answer
What is the primary objective of this project?e.g.,
[X] Quality control of images received in teledermatology
[ ] Support for Primary Care diagnosis
[ ] Support for Dermatology diagnosis
[X] Support for HCP in automatic severity measurement
[X] Support for patients in automatic severity measurement
[ ] Appropriateness of referrals
[ ] Clinical validation
[ ] Improve diagnosis
[ ] HCP satisfaction
[ ] Operational efficiency
[ ] Other
Do you want your users to interact with Legit.Health’s solution through your own software?[X] Yes
[ ] No
[ ] Not sure yet
Which features do you need?
(you can select multiple)
[X] Image quality analysis
[ ] Diagnostic support
[X] Automatic severity assessment
[ ] Other
Psoriasis
Which conditions/pathologies are you interested in evaluating?List of dermatological conditions relevant to your project
e.g.,
[ ] Inflammatory Diseases
[ ] Infectious Diseases
[ ] Autoimmune Diseases
[ ] Genodermatoses
[ ] Vascular Diseases
[ ] All
[ ] All but with focus on x, y, z.
EN
Which languages do you need the solution to support?e.g., English, Spanish, German...
Do you already have a project definition?[ ] Yes
[ ] No
[X] In progress

Technical Setup & Integration​

QuestionExpected Answer / InstructionsCustomer's Answer
What type of integration do you need?
(you can select multiple)
[X] I will send images programmatically and need results in JSON format
[ ] I need a UI for uploading images
[ ] I need a UI to display results
[ ] Sync with internal database
Do you plan to integrate Legit.Health into your own software platform?[X] Yes
[ ] No
[ ] Other
Who will upload the images to Legit.Health?[ ] Healthcare professional
[X] Patient
[ ] Both
[ ] Other
How would you like to receive the Legit.Health results?[X] JSON
[ ] PDF
[ ] Web interface
[ ] Other
Who will access to the Legit.Health results?[ ] Healthcare professional
[X] Other (Patient)

Timeline & Users​

QuestionExpected Answer / InstructionsCustomer's Answer
When would you like to start the integration and go live?Estimated date (YYYY-MM-DD)Service deployment date: 2026-03
Estimated duration of the projectIn months or years1 year
How many dermatologists will use the solution?Estimated numberN/A
How many primary care physicians will use the solution?Estimated numberN/A
How many patients do you estimate will use the solution?Estimated number1st year: 9,000
3rd Year: up to 91,000
Number of medical centers involvedEstimated numberN/A
Estimated number of diagnostic reports per monthApproximate volumeAssumption is 1 photo of a given body area every per week: 9,000 patients x 1 photo per week (=1 body area) x 4 weeks = at least 36,000 diagnostic reports per month

Comments & Open Questions​

QuestionExpected Answer / InstructionsCustomer's Answer
Do you foresee any challenges we should be aware of?e.g., Internal resources, approvals, data access
General comments or questionsOpen field

Project details summary​

  • Primary Objective: e.g., Quality control of images received in teledermatology

  • Integration Type: e.g., I will send images programmatically and need results in JSON format

  • Features Needed: e.g., Image quality analysis, Diagnostic support, Automatic severity assessment

  • Conditions of Interest: e.g., Inflammatory Diseases, Infectious Diseases

  • Languages Supported: e.g., English, Spanish

  • Project Definition: e.g., Yes, we have a project definition document

  • Integration Needs: e.g., I need a UI for uploading images, I need a UI to display results

  • Timeline: e.g., Start integration on 2023-01-01, Go live on 2023-06-01

  • Users: e.g., 5 dermatologists, 10 primary care physicians, 100 patients

  • Data Handling: e.g., As little identifiable patient data as possible, No need for data storage on our infrastructure

  • Challenges: e.g., Internal resources, approvals, clinical data access

Customer's Objective Validation​

  • Example Report: e.g., Link to example report
  • Validation: e.g., Results align with our objectives, Need adjustments in severity assessment
  • Next Steps: e.g., Schedule a follow-up meeting to discuss integration details

Product options overview​

Other services overview​

Time until project starts​

⌛ Low

⌛⌛ Middle

⌛⌛⌛ High

Note: These levels represent estimated time requirements before the project kickoff.

Integration effort (Customers' side)​

🔌 Low

🔌🔌 Middle

🔌🔌🔌 High

Development effort (Legit.Health's side)​

🛠️ Low

🛠️🛠️ Middle

🛠️🛠️🛠️ High

User Satisfaction (HCP)​

⭐ Low

⭐⭐ Medium

⭐⭐⭐ High

General effort overview​

🟢 Low effort

🟡 Middle effort

🟠 Middle-high effort

🔴 High effort

Customer goal examples​

Project timeline and milestones​

To achieve the goals, the parties agree on the following timeline.

Technical requirements summary​

📦 Technical Deliverables & Integration Requirements (from Legit.Health to Customer)​

What Customer NeedsDescriptionDelivered by Legit.HealthClarifications / Notes
API Endpoint SpecificationFull documentation of the /severity-measurement endpoint, including request/response format (JSON only), field definitions, and constraints.✅ Legit.Health (Tech Lead, PM)JSON-only format. No other input types (e.g. XML, form-data) are supported.
Example PayloadsSample input and output JSON structures for different clinical scenarios (e.g., mild, moderate, severe cases).✅ Legit.HealthHelps Customer implement input UI and validate integration.
API Key & AccessSecure API credentials for pre-production and production environments.✅ Legit.HealthAccess will be provided after contract signing. Rate limits and access tiers defined.
Validation & Input RulesGuidance on how to structure and validate user inputs (e.g., required fields per region, accepted value ranges).✅ Legit.HealthCustomer is responsible for client-side validation to prevent malformed requests.
UI Mapping GuidanceInstructions or examples to help match API inputs to visual UI elements (e.g., signs, region selectors).✅ Legit.Health (Clinical + UX Support)Legit.Health will guide on what inputs are needed per region, but will not design the UI.
Error Codes & TroubleshootingAPI error handling documentation, including HTTP codes, validation errors, and retry recommendations.✅ Legit.HealthCustomer must handle 4xx/5xx gracefully in app UX.
Monitoring & Logging (Post-GoLive)Info on what logs Legit.Health collects (e.g., request time, status codes) and what is exposed to customers, if any.✅ Legit.HealthCustomer is responsible for app-level monitoring and alerting.
Integration Support WindowTimeframe and scope for technical Q&A, support during onboarding and first integration.✅ Legit.Health (Support)Includes response SLAs during integration and feedback phase.
Concordance Validation (Optional)Support to validate API outputs on a sample of cases with internal QA or clinical leads at Customer.🔄 Legit.Health (QA / Clinical Advisor)Optional – helps ensure patient-reported input maps correctly to severity scoring logic.

Project tasks​

🧭 Definition & planning​

TaskDescriptionResponsibleStatus
Project conception and initiationInitial ideation and opportunity scoping with all key stakeholders.Deal Owner, JD-013✅ Completed
Definition and planningDefine project details: scope, key deliverables, timelines, success metrics, and required resources.Deal Owner, JD-013⏳ Pending
Implementation plan definedProject scope, key deliverables, timelines, success metrics, and required resources are defined and clear& JD-003 or JD-013 or JD-007⏳ Pending

📝 Contracting​

TaskDescriptionResponsibleStatus
Offer SentFormal offer/proposal shared with the client for review.Deal Owner, JD-002⏳ Pending
Offer ApprovedClient reviews and approves the proposed scope, terms, and pricing.⏳ Pending
Contract ReviewAlign on deliverables, timelines, legal and data terms.⏳ Pending
Contract SigningFinalize and sign all contractual agreements.⏳ Pending

🔌 Integration workflow​

TaskDescriptionResponsiblesTimelineStatusDependencies
Technical onboardingProvide comprehensive API documentation, technical walkthroughs, and UI/UX guidance for both patient and HCP views.Legit.Health (PM, Tech Lead), Customer (Product, Dev)Month 1, Week 2⏳ PendingKick-off meeting
API AccessAfter contract signed, generate and deliver API keys. Access to both production and testing environments.Legit.Health (Tech Ops)Month 1, Week 3⏳ PendingContract signed
Professional ServicesExpert support from technicians, consultants, and project managers.. Review API input/output structures and align with UI mockups for surface input, scoring feedback, and reports.Customer (UX/UI, Frontend), Legit.Health (PM)Month 2, Week 2⏳ Pending
Preproduction environment TestingValidate integration in pre-prod using sample cases; assess scoring accuracy, latency, and input handling.Customer (QA), Legit.Health (QA, Clinical Advisor)Month 3⏳ PendingInterface mapping
Production environment TestingConduct final functional testing with production endpoints using real patient flows and edge cases.Customer (Dev, QA), Legit.Health (Support)Month 5, Week 1⏳ PendingConcordance validation
Launch Readiness & Go/No-GoFinal checklist review, rollback plan, support contact escalation paths, and stakeholder sign-off.Legit.Health (PM), Customer (PM), Customer drug (Stakeholder)Month 6, Week 1⏳ PendingOptional, depending on work order
Customer service deployment into productionOfficially deploy the service to production, ensuring all components are live and operational. ∫Legit.Health (Tech Ops), Customer (DevOps)2026-03-01⏳ Pending
Post-Launch Support & TuningProvide immediate support coverage, monitor usage patterns, and refine based on real-world feedback.Legit.Health (Support), Customer (Support, Product)Month 6 onward⏳ Pending

🚀 Project Execution​

TaskDescriptionResponsibleStatus
User OnboardingTrain stakeholders (e.g., medical teams, patients, HCPs) on the app and scoring system.JD-021, JD-016⏳ Pending
Customer Support EnablementSetup and activate helpdesk or in-app support systems.JD-021, JD-016⏳ Pending
Data AnalysisPerform statistical and clinical analysis on severity scores and patient usage.JD-021, JD-016, JD-014⏳ Pending

🔁 Follow-up Meetings (Optional)​

TaskDescriptionResponsibleStatus
Follow-up MeetingFormal review of key findings, feedback, and performance.JD-021, JD-016⏳ Pending
Interim ReportSummary report of current status, insights, and recommendations mid-project.JD-021, JD-016⏳ Pending

✅ Project Close​

TaskDescriptionResponsibleStatus
Final ReportAnalyze final outcomes, compare against objectives, and document results.JD-021, JD-016⏳ Pending
Define Next StepsOutline future roadmap, improvements, or additional collaborations.JD-021, JD-016⏳ Pending

Project leads​

TeamCodeLeader of
Legit.HealthJD-002, JD-019, JD-021Sales Manager, Business Development Manager, Account Manager
Legit.HealthJD-003, JD-013Design and Development Manager, Project Manager
Legit.HealthJD-018Clinical Research Manager
Legit.HealthJD-004Quality Manager & PRRC
Legit.HealthJD-007, JD-010Technology Manager, Software developer
Legit.HealthJD-005, JD-009Machine Learning Manager, Medical Data Scientist
Legit.HealthJD-014Data Analyst
Legit.HealthJD-016Customer Success Manager
Legit.HealthJD-021Account Manager
Company NameName SurnameProject Director
Company NameName SurnameProject lead

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

  • Author: Team members involved
  • Reviewer: JD-003, JD-004
  • Approver: JD-001
Previous
Copypasters
Next
SP-009-005 Implementation plan helpers for Clinical Trials
  • Understand the Customer's Objective
  • Goals
    • Goals for 1st year
  • Q&A to understand the Customer's objective and requirements
    • Project Scope & objectives
    • Technical Setup & Integration
    • Timeline & Users
    • Comments & Open Questions
  • Project details summary
  • Customer's Objective Validation
  • Product options overview
    • Other services overview
    • Time until project starts
    • Integration effort (Customers' side)
    • Development effort (Legit.Health's side)
    • User Satisfaction (HCP)
    • General effort overview
  • Customer goal examples
  • Project timeline and milestones
  • Technical requirements summary
    • 📦 Technical Deliverables & Integration Requirements (from Legit.Health to Customer)
  • Project tasks
    • 🧭 Definition & planning
    • 📝 Contracting
    • 🔌 Integration workflow
    • 🚀 Project Execution
    • 🔁 Follow-up Meetings (Optional)
    • ✅ Project Close
    • Project leads
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI LABS GROUP S.L.)