GarudaSphere
Trust & Compliance

Intelligence with control, accountability and traceability.

Designed for regulated clinical research—where AI assistance should accelerate work without bypassing accountable review, controlled configuration or attributable release.

Propose Approve Compile Release
Human-Governed AI

AI output stays reviewable until people decide.

Protocol interpretations, study-design proposals, summaries and recommended actions can be prepared by AI, but controlled study setup is based on authorized decisions and approved study intelligence.

Role-Based Access Control
Attributable Review
Electronic Signatures
Version Control
Controlled Approvals
Audit Trail
Data Integrity
Secure Access
Controlled Configuration Principle

Propose → Approve → Compile → Release

AI-generated design is not automatically treated as executable configuration. Approved study intelligence passes through validation and module-specific compilation before controlled release.

AI design proposal Draft
↓
Qualified user review Human
↓
Approved study blueprint Versioned
↓
Validated module compilation Controlled
↓
Attributable release Audit
Traceability by Design

Know where every configuration came from.

GarudaSphere is designed to preserve the relationship between protocol source, interpreted study facts, human decisions and deployed configuration.

1

Source

Protocol section, clause or controlled input document.

2

Interpretation

Structured study fact or AI-generated design proposal.

3

Decision

Authorized review, correction and approval.

4

Compilation

Rule, compiler and version used to build configuration.

5

Execution

Resulting form, edit check, workflow, document plan or application setting.

Design Objectives

Support validated use in regulated clinical research.

GarudaSphere's architecture is intended to support controlled deployment and workflows aligned with applicable clinical-research and electronic-record expectations.

Electronic Records

21 CFR Part 11

Design support for controlled electronic records, signatures, access and auditability.

Good Clinical Practice

ICH-GCP

Workflow design centered on participant protection, data reliability and accountable trial conduct.

Data Integrity

ALCOA+

Architecture intended to support attributable, legible, contemporaneous, original and accurate records.

Validation

Controlled Lifecycle

Support for requirements, testing, release control, traceability and change management.

Trust is part of the product architecture.

Talk to us about human governance, validation strategy, controlled compilation and the deployment model for GarudaSphere.

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