BioMedAna Trust Center

Move faster.
Keep the evidence.

BioMedAna is SOC 2 compliant and designed so bioprocess intelligence remains secure, reviewable and accountable from source record to scientific decision.

✓ Access control✓ Data provenance✓ Model lifecycle✓ Human review✓ Audit trails✓ Operational resilience✓ Environment isolation✓ SOC 2 compliant

01 — CONTROL FOLLOWS THE CHAIN

Trust should travel with the intelligence.

BioMedAna does not treat security as a perimeter around a black box. Identity, lineage, version and review context stay attached as the process moves from evidence to recommendation.

RECORD · BA-2417Source evidence
  • Identity
  • Lineage
  • Version
  • Review
Identity attachedSigned in · ELN user mchen · read scope

02 — GATES, NOT GUESSWORK

Every recommendation passes
through the same gates.

Nothing moves from evidence to action without lineage, version control, explicit uncertainty and a human approval step. The gates are the product, not an afterthought.

03 — ENTERPRISE CONTROLS

Built for serious science at scale.

Practical controls for sensitive process data, governed models and accountable workflows.

Skip card journey ↓
Trust controls in practice01 / 06 ↓ SCROLL TO EXPLORE
01

Identity & access

Role-based access, least privilege and controlled workspaces.

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02

Data provenance

Source-to-decision lineage for records, calculations and model outputs.

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03

Model lifecycle

Version-aware configurations, review history and controlled releases.

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04

Human review

Evidence and approval context before consequential scientific action.

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05

Operational resilience

Monitored service operations, backups and recovery practices.

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06

Environment control

Clear separation between development, validation and production contexts.

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04 — SHARED RESPONSIBILITY

Clear platform controls.
Clear customer ownership.

BioMedAna provides the platform safeguards; each customer retains responsibility for intended use, validation scope, access policy and regulated procedures.

BioMedAna PROVIDES
  • Secure platform and service operations
  • Workspace, role and access controls
  • Evidence, model and decision lineage
  • System activity and review mechanisms
CUSTOMER GOVERNS
  • Intended use and risk classification
  • Validation and qualification strategy
  • User access, procedures and retention
  • Final scientific and quality decisions

05 — DEPLOYED WITHOUT A RIP-AND-REPLACE

Target value in 8–12 weeks.
Not a year-long transformation.

BioMedAna is designed to meet data where it already lives, configure around the customer's process, and deliver measurable value without requiring a platform overhaul.

TYPICAL ENTERPRISE ROLLOUT8–12+ monthsNew platform layer across teams
BioMedAna TARGET8–12 weeksTo initial, measurable value

06 — SECURITY REVIEW

The materials your team needs to evaluate BioMedAna.

We support focused security, architecture and governance reviews with materials matched to the deployment conversation.

Request the review package ↗
01
Security overview

Platform boundaries, service architecture and control approach

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02
SOC 2 materials

Current compliance documentation available under appropriate terms

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03
Data-flow review

Sources, workspaces, isolation and deployment-specific boundaries

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04
Governance mapping

Evidence lineage, model lifecycle, review and approval controls

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07 — QUESTIONS WE GET OFTEN

Straight answers before the pilot.

Is BioMedAna SOC 2 compliant?

Yes. BioMedAna is built on the OpenAna platform foundation, which is SOC 2 compliant. Security materials are available on request.

Can BioMedAna operate in a validated GxP environment?

BioMedAna provides the platform controls — access, lineage, versioning and audit trails — that validated environments require. Validation scope, qualification protocols and intended-use classification remain the customer's responsibility.

Does BioMedAna make decisions automatically?

No. Every Twin recommendation is presented with evidence, uncertainty and a required human review and approval step before it informs a scientific or manufacturing decision.

Where does our process data live?

Access, workspace isolation and data boundaries are configured per deployment. Multi-program and CDMO customers can isolate client data while still reusing platform-level intelligence.

Trust starts before deployment

Bring security and science into the same room.

Request the current trust materials and map BioMedAna to your deployment and validation needs.

Start a trust review ↗

Scientific AI governance: principles and evidence

Read the FDA–EMA Good AI Practice white paper for the ten principles and a scientific review workflow, and the draft Annex 22 white paper for GMP scope, testing and lifecycle evidence.