Supplier Lifecycle Scope
Onboard · Qualify / Re-qualify · Screen · Update · Promote to Production
The same framework also supports re-certifications, banking updates, insurance renewals, and other supplier lifecycle needs.
Project SnapshotsTransMedics
TransMedics · Medical Technology
iApprove™ Supplier Lifecycle Management
Strengthening Supplier Onboarding for a Highly Regulated Environment
How TransMedics uses iApprove™ to guide requests, capture compliance data, route approvals, and move approved supplier records into QAD with complete history.
The Client
A medical technology company transforming organ transplantation.
TransMedics is a commercial-stage medical technology company. Its FDA-approved Organ Care System supports lung, heart, and liver transplantation in the U.S., paired with a nationwide clinical and logistics network.
Opportunity / Challenge
Complex onboarding had to become provably controlled, secure, and audit-ready.
Supplier onboarding had to support security, controlled approvals, supplemental compliance data, traceability, validation evidence, and disciplined QAD execution.
01
Multi-Stakeholder Onboarding
Many people, steps, and one-off exceptions slowed the process and complicated routing.
02
Supplemental Compliance Data
Information such as Sunshine Act details did not live in standard QAD supplier fields.
03
Regulated Control & Validation
SOC and GxP expectations, including Part 11 considerations, required secure, validated controls.
04
QAD Execution & Auditability
Approved supplier records needed automatic QAD execution with tamper-evident history.
Control Requirement: The process had to be provably secure, controlled, validated, and audit-ready.
Solutions Implemented
One iApprove™ supplier lifecycle workflow - from guided intake through QAD promotion.
TransMedics implemented iApprove™ to capture required information, qualify and screen suppliers, route controlled approvals, preserve history, and write approved records to QAD.
01 · Supplier Lifecycle Management
Guided intake through controlled QAD promotion.
Dynamic forms, qualification questionnaires, and required supporting information. Required fields, lookups, duplicate checks, document tracking, and screening. Route by supplier type, risk, or location with reminders and escalations. Create or update QAD without re-entry; integration issues move to fix-and-retry. Dynamic forms, questionnaires, scoring, and re-qualification cadence structure the request. Required fields, duplicate checks, document controls, and debarment screening improve control. Human-controlled approvals precede QAD write-back; exceptions move to fix-and-retry. Common QAD Backbone: Human-controlled approvals | Defined exception ownership | Controlled production promotion | Complete traceability
- Guided Intake & Qualification
- Validation & Screening
- Approval & QAD Promotion
Why This Solution / Key Capabilities
Control supplier information, approvals, compliance, and QAD promotion in one lifecycle workflow.
Select any capability to expand the source-supported detail.
01Policy-Driven Routing+
Route by supplier type, risk, location, and qualification requirements.
02Document Lifecycle+
Track COI, BAA, W-9, expirations, renewals, and supplemental data.
03Audit History & E-Signatures+
Preserve changes, comments, attachments, approvals, and timestamps.
04SOC-Minded Security & Validation+
Role-based access, segregation, change control, encryption, and risk-based testing.
05Automated Risk Screening+
OIG, SAM, OFAC, and FDA checks route exceptions to Compliance.
06Visibility & Controlled Promotion+
Dashboards, reports, UAT/production gates, and retention rules support oversight.
Results / Benefits
Expected benefits - with a clear framework for measuring business impact.
The approved project scope defines intended benefits and measurement targets. These are expected outcomes - not claims of achieved results.
Median cycle time% within SLA
First-pass yieldDefects per 100 onboardings
Mean time to resolveHours saved vs. baseline
Expected benefit
Faster Onboarding
Track median cycle time and the percentage completed within SLA.
Expected benefit
Better Data, Fewer Errors
Improve first-pass yield and reduce duplicates or defects.
Expected benefit
Stronger Compliance
Improve inspection readiness through controls, signatures, and lineage.
Expected benefit
Audit-Ready Traceability
Connect QAD vendor records to approvals and supporting artifacts.
Expected benefit
Lower Risk & Faster Exceptions
Reduce missed steps and improve mean time to resolve.
Expected benefit
Visibility & Extension
Improve SLA transparency and extend the framework across lifecycle events.
The Takeaway
GUIDED INTAKE | QUALIFICATION & SCREENING | HUMAN-CONTROLLED APPROVALS | QAD WRITE-BACK | COMPLETE HISTORY
See how ISS Group can help you evaluate a controlled, QAD-integrated supplier lifecycle workflow.
