Skip to content

VALIDATION_PLAN.md

Latest commit

 

History

History
117 lines (94 loc) · 5.52 KB

VALIDATION_PLAN.md

File metadata and controls

117 lines (94 loc) · 5.52 KB
Raw

TransTrack Validation Plan

Document control
Document ID TT-VP-001
Version 1.0
Status Template — to be ratified by deploying organization
Effective date to be set on ratification
Author Engineering
Approver Quality Assurance Officer

1. Purpose

This Validation Plan describes the activities, roles, deliverables, and acceptance criteria that the deploying organization shall execute to validate TransTrack as fit for its intended use within its quality management system.

2. Scope

In scope:

  • The TransTrack desktop application (Electron) and its embedded SQLite (SQLCipher) database.
  • All bundled IPC handlers, services, and migrations.
  • Backup, restore, audit logging, MFA, and SIEM forwarding subsystems.

Out of scope:

  • The customer's host operating system, identity provider, network, and SIEM — these are validated by the customer's IT department under their own SOPs.
  • Clinical decision-making — TransTrack is an operational/coordination system and does not perform allocation or diagnosis.

3. Regulatory framework

Framework Applicability
HIPAA Security Rule (45 CFR §164.308 / .310 / .312) Applies. See HIPAA_SECURITY_RULE_MAPPING.md.
HIPAA Privacy & Breach Notification Rules (45 CFR §164.500 / 164.400) Customer responsibility; supported by audit logs and breach-notification policy.
21 CFR Part 11 Applies if the customer treats TransTrack records as 21 CFR Part 11 electronic records. See PART_11_CONTROL_MAPPING.md.
21 CFR §860 / §820 (Quality System Regulation) Customer-dependent — see FDA_DEVICE_RATIONALE.md.
OPTN Policies / 42 CFR §121 Operational; TransTrack does not perform UNet-equivalent allocation.
GAMP 5 TransTrack is treated as Category 4 (configurable) software.
ISO 14971 Risk management framework adopted in RISK_REGISTER.md.
ISO/IEC 27001 / SOC 2 Customer-dependent attestation.

4. Validation lifecycle

We adopt a V-model with explicit traceability between left-leg (specification) and right-leg (verification) artifacts:

URS  ─────────────────────────────────────────────►  PQ
   SRS  ──────────────────────────────────►  OQ
       SDS  ────────────────────►  IQ
Stage Artifact Owner Required?
User Requirements SYSTEM_REQUIREMENTS_SPECIFICATION.md Customer + Vendor Yes
System Requirements SYSTEM_REQUIREMENTS_SPECIFICATION.md Vendor Yes
Design SOFTWARE_DESIGN_SPECIFICATION.md Vendor Yes
Risk Analysis RISK_REGISTER.md Customer + Vendor Yes
Installation Qualification templates/IQ_PROTOCOL_TEMPLATE.md Customer Per install
Operational Qualification templates/OQ_PROTOCOL_TEMPLATE.md Customer Per major release
Performance Qualification templates/PQ_PROTOCOL_TEMPLATE.md Customer Per major release
Validation Summary VALIDATION_SUMMARY_REPORT_TEMPLATE.md Customer (QA) Per major release
Periodic Review customer SOP Customer (QA) Annually

5. Roles and responsibilities

Role Responsibility
Customer Quality Assurance Officer Approves the Validation Plan, signs the Validation Summary Report, owns periodic review.
Customer Transplant Administrator Approves URS, executes PQ scripts.
Customer IT / Security Approves IQ, owns infrastructure (OS, network, SIEM, IdP).
Vendor Engineering Maintains SRS, SDS, traceability matrix, regression tests.
Vendor Release Manager Provides release notes, signed installers, test summaries.

6. Acceptance criteria

A release is validated for production use when all of the following are true:

  1. SRS, SDS, Risk Register, and Traceability Matrix have been reviewed and the deltas from the previous validated release are documented and approved.
  2. IQ has been executed on each target machine and 100% of mandatory checks pass.
  3. OQ has been executed and 100% of test cases marked Mandatory pass.
  4. PQ has been executed against the customer's representative workflow with no unresolved Severity 1 or Severity 2 defects (per RISK_REGISTER.md).
  5. The Validation Summary Report is signed by the Quality Assurance Officer.
  6. The signed report and supporting evidence are stored in the customer's document control system for the retention period defined in policies/DATA_RETENTION_AND_DESTRUCTION.md.

7. Change control during validation

Any change to the system after IQ but before VSR sign-off invokes the change-control SOP (policies/CHANGE_MANAGEMENT_SOP.md). Patches that fix non-validated functionality may proceed under "delta validation" (re-run only impacted OQ/PQ sections).

8. Periodic review

The Quality Assurance Officer shall conduct a documented periodic review at least annually covering:

  • Audit log integrity sample
  • Backup restore drill (per BCDR policy)
  • Access review (RBAC + MFA enrollment)
  • Open risks vs. mitigations
  • CVE / security advisories impacting bundled components (Node.js, Electron, SQLCipher, etc.)

9. Supporting standards

  • GAMP 5 (ISPE, 2nd ed.)
  • ISO 14971:2019 — Risk management for medical devices
  • IEC 62304 — Software lifecycle for medical device software (informational; not invoked unless customer treats TransTrack as a medical device)
  • NIST SP 800-66 Rev. 2 — Implementing the HIPAA Security Rule