What is ready now.
The public demo is verified for its stated scope. A validation package is ready. Each customer still tests and approves the exact production deployment before regulated use.
- 01Demo verified
The public build and synthetic workflows were checked against the published demo scope.
- 02Validation package ready
Requirements, risk, traceability, test, deviation, and summary templates are available.
- 03Customer approval required
Each customer must test and approve its production release, setup, and intended use.
Three labels.
One clear path.
We use the same three labels throughout the site so demo checks, supplier evidence, and customer approval are never confused.
Requirements coverage is not certification. Standards can be included in the PRD even when no ISO certificate is claimed.
What the product covers.
Requirements show what the product is designed to support. Demo status shows what you can try here. Production status shows what remains before regulated use.
| Capability | Requirements | Public demo | Production use |
|---|---|---|---|
| Medical-device and IVD eQMS workflows | Included in the 1,027-requirement PRD | Verified for the public demo scope | Customer validation and approval required |
| Medical-device software lifecycle support | Applicable ISO 13485, ISO 14971, IEC 62304, and IEC 62366-1 requirements included | Supporting evidence workflows shown; software-development execution is not included | Customer validates its use and connected processes |
| Therapeutic biotech and regulated labs | Separate expansion; not in the current device and IVD PRD | Concept preview only | Additional requirements and validation needed |
| MES, EBR, LIMS, ERP, and pharmacovigilance execution | Not included | Not shown | Use qualified specialist systems |
Passed with zero structure errors.
- Requirements
- 1,027
- Modules
- 111
- Structure errors
- 0
- HIPAA requirements
- 12
Separate source-corpus status: 157 cited official-source downloads still need recovery. They do not change the zero-error PRD structure result, but they keep the legal corpus from being called fully scan-ready.
Built for administrative eQMS work.
QMS Studio helps manage quality records and evidence. It does not replace software-development, manufacturing, laboratory, ERP, or pharmacovigilance systems. Standards in the PRD are requirements coverage, not ISO certification.
See the workflows.
Take the validation package.
The public workspace uses synthetic records and does not save production changes.