Built for regulated environments.
Security isn't an afterthought.
Pharmaceutical quality data is among the most sensitive enterprise data that exists. BioWise was designed with that in mind from day one — not retrofitted for compliance after the fact.
Architecture security
Security controls embedded at every layer of the stack, not bolted on at the perimeter.
Zero Trust
Identity-aware access. Every request authenticated. No VPN required.
Suppliers access only their own data. Per-resource permissions replace network-level trust. Access decisions are made on identity, not network location — aligned with NIST SP 800-207 zero trust principles.
Encryption
Data encrypted at rest and in transit. MFA required for all users.
AES-256 at rest, TLS 1.3 in transit. MFA TOTP secrets are encrypted at rest using Fernet/PBKDF2. JWT sessions are scoped and short-lived. Electronic signatures use cryptographic hashing per 21 CFR Part 11 requirements.
Multi-tenancy
Row-level security at the database layer. Your data never touches another tenant's queries.
Tenant isolation is enforced at the PostgreSQL row-level security (RLS) layer — not just in application logic. Every query is scoped to the authenticated tenant at the database level, so a misconfigured application layer cannot leak cross-tenant data.
Compiled security modules
4 Cython-compiled security modules. Not Python, not interpretable.
The audit engine, signature engine, ontology core, and security core are compiled to native C extensions via Cython. They cannot be read or modified at runtime. This protects the integrity of the audit trail and electronic signature implementation — the two most critical components for 21 CFR Part 11.
Compliance certifications
The regulatory frameworks that pharmaceutical security teams ask about first.
Electronic records and electronic signatures. Audit trails, access controls, system security, closed and open system requirements. Implemented throughout — not a checkbox.
Computerized systems requirements for EU market access. Data integrity, system validation, operational checks, and incident management aligned with Annex 11.
Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring, and Available. Enforced at the data model and audit layer.
Computer System Validation under GAMP 5 risk-based approach. IQ/OQ/PQ documentation package is complete — 46 test cases, all passing. Shortens your validation timeline significantly.
SOC 2 Type II audit is currently in progress with target completion Q2 2026. Security controls (Trust Services Criteria) are in place and auditor engagement is underway. Report available for Enterprise customers on request once complete.
Article 17 (right to erasure) and Article 20 (data portability) implemented. Data residency controls, DPA agreements, and consent management built in.
For security teams
The three questions pharmaceutical IT and security teams ask most often.
Pre-built IQ/OQ/PQ validation package — reduces your CSV timeline from 6 months to 4-8 weeks
Computer System Validation typically takes 3–6 months and $50–150K when done from scratch. BioWise ships a complete validation package — Installation Qualification, Operational Qualification, and Performance Qualification — with 46 documented test cases, all passing. For a read-only integration layer, this reduces your CSV timeline to 4–8 weeks.
Air-gapped deployment available — all AI runs on-premises with Ollama
All AI functionality runs on-premises using Ollama — no data leaves your network. For organizations that cannot allow patient or batch data to reach external AI providers, BioWise supports fully air-gapped deployments where every AI model runs locally. The same agents, same output quality, no external API calls.
SOC 2 Type II report available on request for Enterprise tier
SOC 2 Type II is in progress (target Q2 2026). Once complete, the full report is available to Enterprise tier customers under NDA. In the meantime, our security team can answer security questionnaires, provide architecture documentation, and schedule a technical review call with your IT team.
Security questions? Talk to our team.
We can answer security questionnaires, provide architecture documentation, and discuss deployment options for your environment.