RegFoundry Studio is the Integrated Compliance Development Environment powered by DAIN — the Domain-Aware Intelligence Network built for regulated life sciences. It gives teams the productivity of modern AI without surrendering control of sensitive data, intellectual property, or regulated decisions. Every request, model interaction, generated artifact, approval, and change is governed by the RegEngine and connected to an auditable system of record.
RegFoundry operates on our controlled AI and software stack, allowing regulated workflows, organizational knowledge, policies, and evidence to remain within a governed environment.
Your compliance logic does not depend on the behavior of a general-purpose model. Models can assist with defined tasks, but the RegEngine controls what they may access, what they may produce, and how their output is evaluated.
When an approved external or general-purpose model is useful, RegFoundry manages the interaction through a governed model gateway. Before information leaves the sovereign environment, policy controls can:
Only the minimum authorized context is sent. External model output returns through the same control layer before it can enter the regulated development record.
The RegEngine connects AI activity to requirements, risks, controls, code, tests, evidence, and approvals. For every governed action, RegFoundry can record:
This creates a traceable chain from intent to implementation — and from implementation to evidence.
Model output is treated as proposed work, not unquestioned truth. RegFoundry evaluates generated artifacts against your approved architecture, regulatory pathway, security policies, quality system, and product requirements.
Depending on the risk, the RegEngine can automatically validate the output, request revision, require human approval, or prevent the change from progressing.
Requirements, architecture, code, tests, risk controls, validation evidence, deployment records, and regulatory documentation remain connected.
When something changes, RegFoundry identifies the affected artifacts, reruns the appropriate checks, and preserves the history needed to explain what changed, why it changed, and who approved it.
RegFoundry supports teams building under frameworks and pathways such as:
Framework coverage is configured to the product, intended use, jurisdictions, risk profile, and organizational quality system. See the article-by-article mapping below.
Each framework below is mapped from the exact regulatory clause to the RegEngine control that produces the evidence. Coverage is configured to your product, intended use, jurisdictions, and quality system.
Electronic records, electronic signatures, and design controls for medical software and SaMD.
| Article | Requirement | RegEngine control | Evidence produced |
|---|---|---|---|
| 21 CFR 11.10(a) | Validation of systems to ensure accuracy, reliability, and consistent intended performance. | RegEngine binds every AI action to an approved chain step, records inputs, model profile, prompt hash, and output. | Validation Summary Report + build_runs trace + chain_steps signature. |
| 21 CFR 11.10(e) | Secure, computer-generated, time-stamped audit trails. | Append-only audit_events with SHA-256 hash chain across artifacts, signatures, and deployments. | Audit export (CSV/JSON) with cryptographic linkage. |
| 21 CFR 11.50 / 11.70 | Signed records include printed name, date/time, and meaning of signature; linked to the record. | SignatureDialog captures typed name + credentials, server signs SHA-256 of artifact payload, binds signature row to artifact id. | signatures table row + Inspection Binder. |
| 21 CFR 820.30 | Design controls: inputs, outputs, review, verification, validation, changes. | Requirements → Risks → Controls → Code → Tests linked through the Traceability Matrix. | Traceability Matrix export + VSR. |
This matrix is illustrative of the RegEngine control surface. Regulatory interpretation is finalized with your quality and regulatory functions; RegFoundry produces the evidence artifacts.
Use powerful AI without giving up sovereignty.
Move faster with modern models while maintaining control over your data, decisions, evidence, and regulated development process.