Compliance
Governed by design.
Altio is built for work that will be inspected. The controls on this page are part of the platform, not settings added later.
Built to the standard of
The frameworks your inspectors expect.
- 21 CFR Part 11 & Annex 11Electronic records and signatures, with each version kept on an immutable audit trail.
- EU AI ActRisk profile: minimal/limited risk; not classified as high-risk. Human-in-the-loop decision support that meets the Act's transparency (Article 50) and AI literacy (Article 4) duties, with Article 95 codes of conduct adopted voluntarily.
- ISO/IEC 42001AI management system discipline for how the platform is built, operated, and changed.
- GxP & CSVDesigned and documented to fit existing Computer System Validation programs without rework.
- GAMP 5A specification and qualification chain built alongside each feature: every Category 5 requirement is traced to the test that proves it, execution against a deployed system is the gate before production handover, and customer configuration is handled as Category 4.
- ICH E2B(R3) and E3Case data read to the standard, and study reports drafted to the guideline's numbering.
- EU GVP Module IXSignal management to the guideline, with every disposition named, reasoned, and traceable.
- CIOMS AI in PVWorking-group guidance on artificial intelligence in pharmacovigilance.
- Extensible by designFrameworks are encoded once at the core and extend to new domains and regulations without rebuilding the platform.
Controls in the platform
Every consequential output traces back to its source.
Reviewers and inspectors can reconstruct a decision months later without reconstructing anyone's spreadsheet.
Immutable audit trail
Every version of every deliverable is kept, with the reviewer, the comment, and the resolution recorded alongside it.
Explainability
Every statement cites the passage it was read from, and each citation is checked back against the source before the answer is delivered.
Electronic signature
Part 11 e-signature on release, with dual sign-off enforced where the deliverable requires it.
Human in the loop
Nothing leaves without a named reviewer. The platform supports the workflow; it does not override it.
PII handling & data governance
Data-class-aware boundaries, redaction at the right layer, and retention controls matched to purpose.
Role-based access
Sign-off lives with the people accountable, and each role sees only the work it is responsible for.
Four behaviors, stated plainly
What the platform will not do.
- It proves its quotesEvery citation is checked back against the source document before the answer is delivered.
- It refuses rather than guessNo figure from model memory, and no statistic from data it does not hold.
- It says what is missingIf a source or data point the answer needs is not in scope, the gap is stated in the deliverable so the reviewer knows what to obtain.
- Numbers come from codeStatistics run as versioned, deterministic code once a person approves the plan.
Deployment
In a dedicated Altio-managed VPC or on premises, under your access model.
Altio deploys in a dedicated Altio-managed VPC or on premises, with the compliance discipline regulated work demands: a GAMP 5 specification and qualification chain, GxP and 21 CFR Part 11 alignment, audit-trail and explainability design, PII governance, role-based access, and human-in-the-loop control.
The platform fits the validation and access model you already run, so inspection readiness is a property of the deployment rather than a project after it.