Operations infrastructure for healthcare
Regulatory governance, provenance, and clinical validation aligned to your evidence.
Key outcomes
- DSCSA-ready chain of custody across the supply network
- Device lifecycle governance with audit-ready evidence
- Clinical pathway validation tied to operational checkpoints
Solution profile
Primary teams
Healthcare ops, medical device QA, hospital supply chain
Regulatory focus
FDA 21 CFR Part 11, QMSR (Part 820 / ISO 13485), HIPAA, DSCSA
Asset scope
Devices, pharma lots, hospital supplies, clinical pathways
Impact Intelligence
Impact Intelligence for healthcare change control
Component supplier changes automatically trigger DHF re-validation, generate IQ/OQ/PQ protocol updates, and compute re-certification costs. Proof paths provide auditable evidence for regulatory submissions.
- Change-impact scoring across device lines and clinical workflows
- Verification tasks and approvals routed to QA and compliance
- Evidence packs remain yours for submission readiness
Engine mapping
Healthcare engines mapped to regulated workflows
Regulatory governance, traceability, and validation stay aligned to evidence.
Engine
Quality & Compliance
Policy controls, e-signatures, clinical pathways, and audit trails aligned to FDA/ISO/HIPAA.
- Controlled documents with required acknowledgements
- Audit evidence tied to every approval
- Protocol-aligned checklists
- Validation evidence for audits
Engine
Forensic Intelligence
Track-and-trace for DSCSA chain of custody, recall readiness, and outcome trends.
- Serialized chain of custody
- Recall-ready evidence trails
- Operational KPIs tied to evidence
- Reliability signals for critical devices
Engine
Physical Assets
Medical device lifecycle visibility and hospital campus to cabinet visibility for critical supplies.
- Device service and calibration history
- Asset readiness linked to clinical use
- Campus to station lineage
- Controlled storage governance
Terminology
Align on the operational language.
Industry teams adopt shared definitions for assets, workflows, and compliance artifacts so every integration stays consistent.
Healthcare terminology map
Shared languageDesign History File (DHF)
QAEvidence record for device design, change history, and approvals.
Device Master Record
RegulatoryApproved manufacturing and inspection procedures for a device line.
UDI
Supply chainUnique Device Identifier tied to serialized traceability and recalls.
Chain of custody
ComplianceDocumented custody trail across distributors, hospitals, and clinics.
Clinical pathway
OperationsValidated care workflow with required checkpoints and approvals.
IQ/OQ/PQ protocol
ValidationValidation protocol for installation, operation, and performance.
Workflow
From device registration to clinical validation
How compliance evidence, traceability, and workflows stay audit-ready.
Step 1
Register devices and lots
Normalize UDI, GSII, and lot data for serialized chain-of-custody tracking.
Step 2
Validate clinical workflows
Run clinical pathways with checklists, approvals, and protocol evidence.
Step 3
Monitor chain of custody
Track DSCSA events across distributors, hospitals, and care sites.
Step 4
Respond to change impact
Supplier or design changes trigger DHF updates and re-validation tasks.
Compliance
Compliance proof anchored to your evidence
Healthcare frameworks map to your audit trails, validation protocols, and retention policies.
FDA 21 CFR Part 11 + QMSR
Electronic records and device QMS alignment (QMSR incorporating ISO 13485:2016) with audit trails.
ISO 13485
Design controls, risk management, and controlled documentation.
HIPAA + SOC 2
PII-safe access governance and tamper-evident logging.
DSCSA
Track-and-trace with serialized chain of custody evidence.
GxP (GMP/GDP)
Validation and release controls for manufacturing and distribution.
Proof points
Evidence that resonates with operators.
Traceability
End-to-end
Serialized evidence stays linked across devices, lots, and locations.
Validation
Protocol-led
Clinical workflows stay aligned to IQ/OQ/PQ requirements.
Compliance packs
Evidence-ready
Tenant-owned audit artifacts stay ready for submission.
Case studies
Stories that map outcomes to industry metrics.
Embedded operations
On-the-ground supplier audits and compliance monitoring
Need FDA QSR audits, sterilization validation, or weekly compliance monitoring for your Asia suppliers? Our embedded ops network provides 15+ years of on-the-ground healthcare operations.
Explore Embedded Ops