Part of The Fortress Family
Evidence Engine
FDA-Ready Audit Trails for Life Sciences AI
Evidence Engine is BioCompute's FDA 21 CFR Part 11 compliant audit trail system that creates immutable evidence books with complete data provenance for life sciences AI workflows. IEEE 2791 aligned and accepted by the FDA for regulatory submissions.
What Problem Does Evidence Engine Solve?
Life sciences organizations face a critical evidence gap: AI-driven analyses generate insights faster than ever, but regulatory submissions still require complete, auditable documentation of every step. Manual documentation takes weeks, creates compliance risk, and often fails FDA inspection. Evidence Engine closes this gap by automatically generating submission-ready evidence as analyses run.
Compliance Risk
Manual documentation creates audit gaps and data integrity issues that threaten FDA submissions
Weeks of Delay
Traditional audit trail creation adds weeks to submission timelines through manual curation and retrofitting
Inspection Failure
Incomplete provenance and missing timestamps lead to FDA warning letters and delayed approvals
Before Evidence Engine
- ✗ Manual audit trail creation
- ✗ Disconnected documentation systems
- ✗ Compliance retrofitting
- ✗ Weeks to prepare submissions
- ✗ Inspection anxiety
After Evidence Engine
- ✓ Automatic evidence generation
- ✓ Unified audit trail
- ✓ Compliance built-in
- ✓ Hours to submission-ready
- ✓ Inspection confidence
What Is an Evidence Book?
An Evidence Book is an immutable, cryptographically signed record of an entire analysis workflow—from raw data input through final results. It contains complete provenance (who performed each action, what was done, when it occurred, and why), all parameters used, software versions, and comprehensive audit trails. Evidence Books are submission-ready for FDA, EMA, PMDA, and other regulatory authorities.
Anatomy of an Evidence Book
Provenance Domain
Complete chain of custody: who created, modified, and approved each element. Cryptographic signatures ensure authenticity.
Execution Domain
Exact computational environment: software versions, parameters, hardware specifications, and runtime configuration.
Input/Output Domain
Every data input with checksums, every output with validation. Complete traceability from source to result.
Description Domain
Human-readable documentation of the analysis purpose, methodology, and scientific context.
Audit Trail
Time-stamped log of every action: creation, modification, deletion, access, and approval events.
What Are Evidence Engine's Core Capabilities?
Evidence Engine provides six core capabilities: automatic audit trail generation, immutable evidence books, cryptographic signatures, FDA 21 CFR Part 11 compliance, IEEE 2791 alignment, and submission-ready exports. Together, these transform weeks of manual documentation into hours of automated, compliant evidence creation.
Automatic Audit Trails
Every action automatically logged with secure, computer-generated, time-stamped records. No manual documentation required. Changes never obscure previous data.
- ✓ User identification for every action
- ✓ Synchronized timestamps
- ✓ Before/after value capture
- ✓ Reason-for-change documentation
Immutable Evidence Books
Tamper-proof records that cannot be altered after creation. Cryptographic hashing ensures any modification is immediately detectable.
- ✓ Cryptographic integrity verification
- ✓ Complete version history
- ✓ Immutable storage
- ✓ Long-term retention
Electronic Signatures
21 CFR Part 11 compliant electronic signatures linked to records with signer identification, timestamp, and meaning (approval, review, verification).
- ✓ Two-factor authentication
- ✓ Signature meaning capture
- ✓ Non-repudiation
- ✓ Signature manifestation
FDA 21 CFR Part 11 Compliance
Built-in compliance with FDA requirements for electronic records and signatures. Validated system with documented controls.
- ✓ Access controls
- ✓ Operational system checks
- ✓ Authority checks
- ✓ Device checks
IEEE 2791 Alignment
Native support for the BioCompute Object standard adopted by FDA for regulatory submissions. Ensures reproducibility and interoperability.
- ✓ Five required domains
- ✓ FDA Data Standards Catalog
- ✓ Cross-platform portability
- ✓ FAIR compliance
Submission-Ready Exports
One-click export of complete evidence packages ready for FDA, EMA, PMDA, and other regulatory authorities. Multiple format support.
- ✓ eCTD compatible
- ✓ PDF/A archival format
- ✓ JSON/XML data exports
- ✓ Regulatory templates
What Compliance Standards Does Evidence Engine Meet?
Evidence Engine is designed for regulated life sciences with FDA 21 CFR Part 11 compliance (electronic records and signatures), GxP-ready validated workflows, HIPAA-compliant data protection, SOC 2 security controls, EU GMP Annex 11 alignment, and IEEE 2791 (BioCompute Object) standard support—the only data framework standard adopted by the FDA.
FDA 21 CFR Part 11
Electronic records and signatures. Secure audit trails, access controls, system validation, and electronic signature requirements.
GxP Quality Systems
Good Practice regulations including GLP (Laboratory), GCP (Clinical), and GMP (Manufacturing) requirements.
IEEE 2791-2020
BioCompute Object standard for bioinformatics workflow documentation. FDA-adopted for regulatory submissions.
EU GMP Annex 11
European requirements for computerised systems in pharmaceutical manufacturing and quality control.
HIPAA
Protected health information safeguards for clinical data and patient information security.
SOC 2 Type II
Security, availability, and confidentiality controls verified through independent audit.
IEEE 2791 (BioCompute Object) is the only data framework standard ever adopted by the FDA's Data Standards Catalog for HTS data submissions. Evidence Engine's native support ensures your workflows are documented to FDA-accepted standards.
What Are Evidence Engine Use Cases?
Evidence Engine supports regulated life sciences workflows including drug discovery (target validation, compound screening), clinical development (biomarker analysis, patient selection), regulatory submissions (IND, NDA, BLA filings), and quality control (batch release, stability testing). Any workflow requiring FDA-grade documentation benefits from Evidence Engine.
Drug Discovery
Document target validation, compound screening, and preclinical studies with complete provenance. Evidence books capture every analysis from hit identification through lead optimization.
Genomics & Bioinformatics
IEEE 2791-compliant documentation for NGS pipelines, variant calling, and multi-omics analysis. FDA-ready evidence for precision medicine applications.
Clinical Biomarkers
Audit-ready evidence for biomarker discovery, validation, and clinical qualification. Support patient selection and companion diagnostic development.
Regulatory Submissions
Generate submission-ready evidence packages for IND, NDA, BLA, 510(k), and international filings. Reduce submission prep time by 90%+.
Quality Control
Document batch release testing, stability studies, and out-of-specification investigations with complete audit trails.
AI/ML Model Validation
Evidence books for AI model training, validation, and deployment. Support EU AI Act and FDA guidance on AI/ML in drug development.
Where Evidence Engine Fits
Evidence Engine is the compliance core of the AI Foundation. Every AI interaction that passes through the AI Gateway and Agentic Hub automatically generates cryptographic audit trails in the Evidence Engine, which feeds into the Compliance Manager for review and ultimately produces submission-ready Evidence Books.
Evidence Books
Per-project, per-regime deliverables
Compliance Manager
Orchestrates compliance lifecycle
Evidence Engine
Immutable compliance proof — audit trails, e-signatures, 21 CFR Part 11
Agentic Hub
Governs what AI agents can do
AI Gateway
Controls what AI models can say and see
Frequently Asked Questions About Evidence Engine
Ready for FDA-Ready Audit Trails?
See how Evidence Engine can transform your compliance workflow from weeks of manual documentation to hours of automated, submission-ready evidence.
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