BioSure was built for labs that get inspected. Every workflow, control, and data policy is documented, auditable, and available to review.
We don't treat compliance as an optional checkbox. Each framework below is aligned to the specific workflow surfaces inside BioSure — not a blanket SOC 2 logo in the footer.
Every report template, air-sampling workflow, and gowning-qualification form is aligned to the 2023 USP 797 revision — with configurable limits for ISO 5 / 7 / 8 cleanrooms.
Every mutation is captured as an immutable record with user, timestamp, intent, and cryptographic attribution. E-signatures meet Part 11 identification, non-repudiation, and linking requirements.
BioSure operates as a Business Associate for labs handling PHI. We sign a BAA on day one and follow the HIPAA Security Rule for administrative, physical, and technical safeguards.
Our cloud infrastructure is built on SOC 2 Type II-audited services. The BioSure application layer is on track for our own Type II report by Q3 2026 — Type I completed January 2026.
Documentation, method validation, and equipment calibration workflows are modelled after ISO 17025 expectations — helping your lab maintain accreditation without duplicating records.
Four domains, continuously audited. Available in a SIG-Lite or CAIQ questionnaire, and documented in our architecture brief (NDA on request).
01 · Data
02 · Access
03 · Infrastructure
04 · Operations
We keep a public register of every service that processes your lab's data. Request a SOC 2 report, CAIQ, BAA template, or penetration-test summary — typical turnaround is one business day.
Amazon Web Services
Primary hosting, object storage
US East / West
Cloudflare
CDN, DDoS mitigation, WAF
Global edge
Postmark
Transactional email delivery
US
Sentry
Error monitoring (opt-in)
US / EU
Stripe
Billing & payments
US
Datadog
Application performance monitoring
US
Continuously audited · 99.97% uptime · 0 data incidents since 2024
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