Authenticated data, run records, instruments and assays.
BioAna Trust Center
Move faster.
Keep the evidence.
BioAna is SOC 2 compliant and designed so bioprocess intelligence remains secure, reviewable and accountable from source record to scientific decision.
CONTROL STATUSALL SYSTEMS GOVERNED
SOC 2 compliant foundationContinuously monitored access, lineage and review controls
01
IdentityAuthenticated access, least privilege
✓02
EvidenceSource lineage preserved end to end
✓03
ModelVersion-aware, controlled releases
✓04
DecisionHuman review and approval required
✓DECISION RECORDCandidate operating region
APPROVEDAccess controlledLineage preservedReview required
01 — CONTROL FOLLOWS THE CHAIN
Trust should travel with the intelligence.
BioAna 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.
Relationships, quality checks, configurations and versions.
Inputs, constraints, uncertainty and interpretation.
Scientist review, approval and an auditable rationale.
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.
EVIDENCESource records
Runs, assays, materials — authenticated and versioned
✓Lineage attached
MODELVersioned model
Configuration, training evidence and validation history
✓Release controlled
RECOMMENDATIONProposed action
Prediction, uncertainty and constraints made explicit
✓Uncertainty shown
REVIEWHuman approval
Scientist reviews evidence before anything moves
✓Approval required
AUDIT TRAILEvery step above is recorded — who, what, when, with which evidence and model version.
03 — ENTERPRISE CONTROLS
Built for serious science at scale.
Practical controls for sensitive process data, governed models and accountable workflows.
Identity & access
Role-based access, least privilege and controlled workspaces.
+Data provenance
Source-to-decision lineage for records, calculations and model outputs.
+Model lifecycle
Version-aware configurations, review history and controlled releases.
+Human review
Evidence and approval context before consequential scientific action.
+Operational resilience
Monitored service operations, backups and recovery practices.
+Environment control
Clear separation between development, validation and production contexts.
+04 — SHARED RESPONSIBILITY
Clear platform controls.
Clear customer ownership.
BioAna provides the platform safeguards; each customer retains responsibility for intended use, validation scope, access policy and regulated procedures.
- Secure platform and service operations
- Workspace, role and access controls
- Evidence, model and decision lineage
- System activity and review mechanisms
- 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
Value in weeks.
Not a year-long transformation.
BioAna is designed to meet data where it already lives, configure around the customer's process, and deliver measurable value without requiring a platform overhaul.
W1W2W3W4W5W6W7W8W9W10W11W12
ConnectWEEKS 1–2
Priority sources connected, read-only, in your environment
ContextualizeWEEKS 2–5
Runs, materials, events and assays aligned into scientific records
First modelsWEEKS 5–9
Baseline predictions validated against held-out historical runs
Governed decisionWEEKS 9–12
First evidence-linked recommendation reviewed in a real workflow
ILLUSTRATIVE 12-WEEK SHAPE — SCOPE AGREED PER DEPLOYMENTMilestone: first governed, evidence-linked decision ✓
06 — SECURITY REVIEW
The materials your team needs to evaluate BioAna.
We support focused security, architecture and governance reviews with materials matched to the deployment conversation.
Request the review package ↗Security overview
↗Platform boundaries, service architecture and control approach
SOC 2 materials
↗Current compliance documentation available under appropriate terms
Data-flow review
↗Sources, workspaces, isolation and deployment-specific boundaries
Governance mapping
↗Evidence lineage, model lifecycle, review and approval controls
07 — QUESTIONS WE GET OFTEN
Straight answers before the pilot.
Is BioAna SOC 2 compliant?
Yes. BioAna is built on the OpenAna platform foundation, which is SOC 2 compliant. Security materials are available on request.
Can BioAna operate in a validated GxP environment?
BioAna 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 BioAna 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 BioAna to your deployment and validation needs.
Start a trust review ↗