Public demo intended use
The exact synthetic-demo purpose, included workflows, exclusions, and safe-use limits.
public-demo-intended-use.md ValidationA clear path to
A clear path to
approved use.
The public demo is verified for its stated scope, and a validation package is ready. Before regulated use, each customer tests and approves its production deployment.
Available nowDemo verified + package ready
- 01Public demoVerified
- 02Validation packageReady
- 03Production useCustomer approval
Production use requires customer testing and approval.
Verified for the public demo scope
The build and synthetic workflows have been checked. Do not enter, approve, or retain real regulated records on this public site.
Three clear statuses
Ready now, then customer-approved.
Supplier evidence reduces validation work. The customer still approves the exact system used for its regulated process.
- 01Verified
Public demo
The build and synthetic workflows were checked against the published demo scope. No regulated records are used.
- 02Ready
Validation package
Requirements, risk, traceability, test, deviation, and summary templates are available for a controlled release.
- 03Customer approval
Production use
The customer tests and approves the exact release, setup, environment, procedures, and intended use.
Who does whatWe provide the package.
We provide the package.
You approve your use.
FDA's current computer software assurance guidance supports risk-based assurance and using relevant supplier evidence. Each customer decides and documents the tests needed for its intended use.
References: FDA Computer Software Assurance guidance; 21 CFR Part 11; FDA QMSR FAQ
- Controlled release notes and configuration guide
- Requirements, risk, traceability, and test evidence
- Known limits and change-impact information
- Security, backup, export, data-integrity, and AI-control documentation
- Define intended use, applicable rules, risks, and procedures
- Configure users, roles, integrations, retention, and environment
- Run and approve customer tests; train users and release
- Monitor use and assess changes
Public demo evidence
See what was checked.
These records apply only to the identified public synthetic demo. They do not validate a production eQMS deployment.
Executed assurance summary
The checks run, results observed, open findings, and release decision for the public demo.
public-demo-assurance-protocol-summary.mdPublic demo traceability
Links each demo claim to a risk, check, result, limitation, and evidence record.
public-demo-traceability.csvMachine-readable status
Release identity, hashes, executed checks, findings, boundaries, and approval gates.
validation-status.jsonCustomer templates
Prepare one production deployment.
These files are templates, not completed customer evidence. Tailor, run, and approve them against the exact production release and environment.
Read me and use boundaries
Scope, boundaries, file list, and official references.
README.mdResponsibility matrix
Who supplies, tests, reviews, and approves each item.
responsibility-matrix.csvValidation protocol
Risk-based test template with space for results and approvals.
validation-protocol-template.csvTraceability matrix
Connect intended use, requirements, risks, controls, tests, and evidence.
traceability-matrix-template.csvDeviation log
Record test issues, impact, action, and closure.
deviation-log-template.csvValidation summary report
Document the result and approval for one production deployment.
validation-summary-report-template.mdPackage manifestVersion, scope, file list, and SHA-256 checksums.
Open manifest Production approval applies to one deployment
Review trust controls Changes to the release, setup, environment, procedures, or intended use may require more testing and approval.