Security & data integrity
Defensible data, from the edge up.
Sterile manufacturing data is both a compliance asset and a competitive one. Sterira protects it with an edge-first architecture, tamper-evident records, strict residency controls, and defense in depth across the stack.
Data integrity
ALCOA+ built into the record.
Attributable
Every record is tied to a specific agent, user, and action.
Legible & enduring
Human-readable and preserved for the full retention lifecycle.
Contemporaneous
Captured at the moment of action, not reconstructed later.
Original & accurate
The source record is preserved and verifiable end to end.
Complete & consistent
No gaps, every action, alarm, and override is logged.
Available
Retrievable on demand for review, release, and inspection.
Architecture
Edge-first by design.
Perception and control run on an on-prem edge node inside your network. Sensitive process data stays local; only the aggregated telemetry you approve leaves the site, encrypted, to your historian or a private tenant.
- Deterministic latency for control loops.
- Data residency you control per site.
- Operates through network isolation.
Access & controls
Enterprise controls, no exceptions.
- 01
Identity
SSO/SAML and role-based access control scoped to least privilege.
- 02
Separation
Multi-tenant isolation for CDMOs running multiple client programs.
- 03
Monitoring
Security event logging and anomaly detection across the stack.
- 04
Recovery
Backup, disaster recovery, and business-continuity procedures.
Tamper-evidence
A trail that stands up to inspection.
The Part 11 audit trail is append-only and cryptographically chained. Any attempt to alter a historical record is detectable, so what you present in an audit is provably what happened.
See compliance mapping →Principles
Security that assumes a regulated network.
Data minimization at the edge
Only approved, aggregated data ever leaves the site.
Least-privilege access
RBAC scoped tightly; every access logged and reviewable.
Provable integrity
Chained, append-only records make tampering detectable.
Security program
How we operate.
Secure development
Code review, dependency scanning, and secrets management in the pipeline.
Vulnerability management
Regular testing and a defined remediation SLA by severity.
Vendor diligence
We complete your security questionnaires and support due diligence.
Incident response
A documented IR plan with notification commitments.
"Edge-first was non-negotiable for us. Our process data never leaves the site unless we approve it, and the audit trail is provably intact. That satisfied both quality and IT security."
Global biopharma
FAQ
Common questions.
Not by default. Raw process data stays on the on-prem edge. Only aggregated telemetry you explicitly approve is synced, encrypted, to your historian or a private tenant.
No undetectably. Records are append-only and cryptographically chained, so any tampering is provable during an inspection.
Yes. We complete security questionnaires, share our security brief, and support vendor due diligence and penetration-test reviews.
Bring it to your security team.
Request the security brief and share it with IT and quality.