Frameworks

The compliance spine is shaped by the frameworks you develop under. Rather than a single hard-coded notion of “compliant,” TraceUnified lets you configure the standards that apply to your work, so the controls and checks match your regulatory context.

The standards supported

The platform supports the frameworks regulated product teams work to, including:

• FDA 21 CFR Part 11 — electronic records and electronic signatures
• FDA 21 CFR Part 820 — the Quality System Regulation for medical devices
• ISO 13485 — quality management systems for medical devices
• ISO 14971 — risk management for medical devices
• IEC 62304 — the medical device software lifecycle
• EU MDR — the European Medical Device Regulation
• GAMP — good practice for computerized systems

Together these span the FDA, ISO, IEC, and EU regimes most programs in this space have to satisfy.

Configured once, applied to projects

Frameworks are defined organization-wide and then attached to the projects they govern (see Project settings). This separation matters: your compliance team configures what each framework requires in one place, and every project that adopts it inherits those requirements consistently — no per-project reinterpretation of the same standard.

Several at once

A real product often has to satisfy more than one framework simultaneously — a medical device might be developed under Part 820, ISO 13485, ISO 14971, and IEC 62304 together. A project can carry multiple frameworks, and their requirements apply in combination, so a single record is checked against everything that governs it rather than one standard at a time.

What frameworks drive

The frameworks a project carries shape the controls and checks throughout it — the controlled states, the signatures, the compliance checks during authoring, and the verification covered next. They turn the generic compliance spine into your specific regulatory obligations. Proving you meet them is the subject of Verification & quality analysis.