Companies
Sofcom
sells SPECTRUM, a quality-management software suite with a named, dedicated Stability Management module for scheduling, chamber tracking, and pull-point testing, built for 21 CFR Part 11 compliance and confirmed on the company's own domain across five separate product and case-study pages.
- Country
- United States
21 CFR Part 11
Coverage
| US | |
|---|---|
| digital-it | ✓ |
Regulatorsfda
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| Stability-study management software | digital-it | High | → |
Compiled by BIOECON from primary sources.
Compliance
Bioecon is an information intermediary; it is not a regulator, a certification body, or a legal advisor. When working with public-sector customers (procurement under 44-FZ / 223-FZ), Bioecon acts solely as an independent analytical platform, with no remuneration from suppliers.