Security, data and compliance in Implant & Tissue Compliance Tracker

How Implant & Tissue Compliance Tracker protects data and supports your compliance obligations.

Security controls

Single sign-on

Staff sign in through your identity provider, so your password and multi-factor policies apply.

Role-based access

What each person can see and do follows their role; materials staff see inventory, not patient details.

Business associate agreement

Implant records link items to patients, and Moraph signs a business associate agreement with you.

Encryption and keys

Client data is encrypted, with keys Moraph staff cannot use without explicit, time-bound authorization.

Complete audit trail

Every scan, view of a patient record, change, disposition and export is logged with the person and time, and cannot be edited.

Data residency

Data stays in the hosting region you choose: the United States, the United Kingdom or Australia.

Requirements it supports

• FDA Human Cells, Tissues, and Cellular and Tissue-Based Products (21 CFR Part 1271)
• FDA Unique Device Identification System (21 CFR Part 830)
• FDA Medical Device Tracking Requirements (21 CFR Part 821)
• FDA Medical Device Reporting, user facility requirements (21 CFR Part 803)
• Joint Commission Transplant Safety (TS) standards for tissue acquisition, storage and tracking
• CMS Conditions of Participation for hospitals, organ, tissue and eye procurement (42 CFR 482.45)

The product supports these requirements; meeting them remains your organization's responsibility.

Where it runs

• Moraph cloud: Hosted and operated by Moraph in the United States region. United Kingdom and Australia regions are available for organizations outside the US.
• Dedicated environment: A single-tenant environment for health systems whose policies require isolation, scoped in the proposal.
• With a managed service: Optionally run alongside Moraph's managed integration engine for interface monitoring and support.

Limitations

• The Tracker records and traces items; it does not decide whether an item is safe to use. Release from quarantine and use are decisions of your staff.
• Traceability depends on items being scanned at each step. Items that bypass scanning are not tracked until they are recorded.
• It does not submit reports to the FDA or to suppliers. Your team decides what to report and submits it, using the records the Tracker keeps.
• Recall matching depends on the recall information received and on the identifiers captured at scanning; items recorded without lot or serial numbers may not match.
• It is not a blood bank system. Blood components and transfusion records are managed separately.
• It is not a temperature monitoring system; it uses readings from yours or from staff logs.
• It does not manage purchasing or consignment billing, which stay in your supply chain system.
• Patient notification and clinical follow-up after a recall are decided and carried out by your clinicians; the Tracker assigns and records the tasks.