Compliance, Safety, and Release Confidence for Life Sciences & Pharma
Automate evidence collection, secure supply chains, and accelerate regulated releases with validated controls and audit‑ready reporting tailored for clinical, manufacturing, and regulated software environments.
Product Portfolio
Regulatory Compliance Engine
Automated control mapping and continuous monitoring for GxP, 21 CFR Part 11, ISO 13485, and regional regulator requirements. Maintain evidence lineage from code and configuration to control assertions.
SBOM & Supply Chain Assurance
Generate CycloneDX/SPDX SBOMs, track component provenance, and score third‑party risk for clinical devices, lab software, and manufacturing systems.
Clinical Release Gate
Automated release gating for validated software and firmware: test evidence, configuration baselines, and control checks required for regulated deployments.
Vulnerability Prioritization for Pharma
Enrich CVEs with exploit telemetry and clinical impact scoring to prioritize fixes that reduce patient safety and regulatory exposure first.
Audit‑Ready Evidence Bundles
One‑click auditor packages with traceability from source artifacts to control assessments, including mapping rationale and timestamps for inspections and audits.
CI/CD Compliance Toolkit
Prebuilt pipelines for SBOM generation, Semgrep rule packs with regulatory metadata, and automated gating to keep validated releases compliant by design.
Solutions by Use Case
Manufacturing & Device Software
Ensure validated firmware and control systems meet quality and safety requirements while maintaining continuous vulnerability monitoring.
- SBOM provenance for device components
- Configuration drift detection for PLCs and embedded systems
- Automated evidence for supplier audits
Clinical & Research Software
Protect patient data, ensure reproducibility, and accelerate validated releases for clinical applications and data pipelines.
- 21 CFR Part 11 control assertions
- Data integrity checks and audit trails
- Automated evidence for IRB and regulator reviews
Quality & Regulatory Affairs
Streamline inspections and submissions with structured evidence exports and control coverage reports aligned to regulatory frameworks.
- OSCAL/OpenControl exports for regulator submissions
- Executive scorecards for compliance posture
- Audit trails and mapping rationale for inspectors