Compliance Automation

    Evidence Books

    Regime-specific compliance packages that automatically compile the documentation regulators need. Hours, not weeks.

    6
    Regulatory Regimes
    40-60%
    Time Reduction
    100%
    Audit-Ready

    EU AI Act enforcement begins August 2, 2026. Life sciences AI systems classified as high-risk must have conformity documentation ready. Read our analysis →

    How Evidence Books Work

    01

    Connect Your Pipeline

    Link your AI development, wet-lab, and clinical data pipelines. BioCompute automatically captures model lineage, data provenance, and validation results.

    02

    Select Your Regime

    Choose the regulatory framework you need to comply with. BioCompute maps your captured evidence to the specific requirements of each regime.

    03

    Generate Evidence Book

    Compile a complete, audit-ready documentation package. Every record is cryptographically signed, timestamped, and immutable.

    6 Regulatory Regimes. One Platform.

    Each Evidence Book is tailored to the specific requirements of its regulatory framework, pulling the right data from your BioCompute workspace.

    FDA 21 CFR Part 11

    United States

    Electronic records and electronic signatures compliance for FDA-regulated industries. Covers validation, audit trails, access controls, and signature authority.

    Key Requirements

    Validated system with documented controls
    Audit trails with computer-generated timestamps
    Electronic signatures with two-factor authentication
    Access controls and authority checks

    What BioCompute Generates

    System validation documentation package
    Audit trail reports with immutable timestamps
    Electronic signature compliance certificates
    60% fastervs. manual process

    EU AI Act (High-Risk)

    European Union
    August 2, 2026

    Conformity assessment documentation for high-risk AI systems in healthcare and life sciences. The most comprehensive AI regulation globally, with severe penalties for non-compliance.

    Key Requirements

    Risk management system with continuous monitoring
    Data governance covering training data quality and bias
    Technical documentation proving safety and efficacy
    Human oversight provisions for clinical professionals

    What BioCompute Generates

    Conformity assessment documentation package
    Risk management system evidence
    Data governance and bias testing reports
    55% fastervs. manual process

    Health Canada AI/ML Guidance

    Canada

    AI/ML-specific regulatory guidance for Software as a Medical Device (SaMD). Covers pre-market requirements, ongoing monitoring, and change protocols for adaptive AI systems.

    Key Requirements

    Pre-market SaMD classification and evidence
    Good Machine Learning Practice (GMLP) documentation
    Predetermined change control plans
    Real-world performance monitoring

    What BioCompute Generates

    SaMD classification documentation
    GMLP compliance evidence package
    Change control protocol records
    50% fastervs. manual process

    ICH Guidelines

    International

    International Council for Harmonisation guidelines covering quality, safety, and efficacy standards. Essential for organizations operating across multiple jurisdictions.

    Key Requirements

    ICH Q8-Q12 pharmaceutical quality system
    ICH E6(R3) Good Clinical Practice
    ICH E9 statistical principles for clinical trials
    Quality by Design (QbD) documentation

    What BioCompute Generates

    Quality system documentation aligned to ICH Q10
    Clinical trial data integrity evidence
    Statistical analysis validation packages
    45% fastervs. manual process

    ISO 13485

    International

    Quality management system standard for medical device design, development, and manufacturing. Critical for organizations producing AI-powered diagnostic and therapeutic tools.

    Key Requirements

    Design and development process documentation
    Design verification and validation records
    Risk management per ISO 14971
    Supplier qualification and monitoring

    What BioCompute Generates

    Design history file (DHF) compilation
    Verification and validation test reports
    Risk management file per ISO 14971
    40% fastervs. manual process

    GxP Compliance

    International

    Good Practice standards spanning GLP (Laboratory), GCP (Clinical), GMP (Manufacturing), and GDP (Distribution). Ensures data integrity and process quality across the entire drug lifecycle.

    Key Requirements

    ALCOA+ data integrity principles
    Computer system validation (CSV/CSA)
    Data backup and disaster recovery
    User access management and segregation of duties

    What BioCompute Generates

    ALCOA+ compliance evidence packages
    Computer system validation documentation
    Data integrity assessment reports
    50% fastervs. manual process
    Fortress Family

    Built on the Reign Foundation

    Evidence Books inherit the zero-trust security, AI governance controls, and enterprise-grade infrastructure of the Reign Fortress Family—trusted by Fortune 500 organizations.

    AI Gateway
    LIVE
    Agentic Hub
    WAIT LIST
    Evidence Engine
    Q2

    Ready to automate your compliance evidence?

    Join our design partner program and be among the first to generate Evidence Books for your regulatory submissions.