Life Sciences & Pharma Compliance Platform

The Life Sciences & Pharma Compliance Platform from WW Technology Group is designed for clinical, manufacturing, and regulated software teams that need to automate evidence collection, secure software supply chains, and accelerate regulated releases. It provides validated controls, audit-ready reporting, and continuous compliance monitoring aligned to GxP, 21 CFR Part 11, ISO 13485, and regional regulatory requirements.

The platform targets quality and regulatory affairs teams, device and firmware developers, and clinical software engineers who require traceable evidence from source artifacts through to control assessments, as well as structured outputs suitable for inspections, audits, and regulator submissions.

Product Capabilities

• Regulatory Compliance Engine: Automated control mapping and continuous monitoring for GxP, 21 CFR Part 11, ISO 13485, and regional regulator requirements, with evidence lineage maintained from code and configuration to control assertions.
• SBOM & Supply Chain Assurance: Generates CycloneDX and SPDX SBOMs, tracks component provenance, and scores third-party risk for clinical devices, lab software, and manufacturing systems.
• Clinical Release Gate: Automated release gating for validated software and firmware, requiring test evidence, configuration baselines, and control checks before regulated deployments proceed.
• Vulnerability Prioritization for Pharma: Enriches 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 providing 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: Supports validated firmware and control systems with continuous vulnerability monitoring, SBOM provenance for device components, configuration drift detection for PLCs and embedded systems, and automated evidence for supplier audits.
• Clinical & Research Software: Addresses patient data protection, reproducibility, and validated release acceleration for clinical applications and data pipelines, including 21 CFR Part 11 control assertions, data integrity checks, audit trails, and automated evidence for IRB and regulator reviews.
• Quality & Regulatory Affairs: Supports inspections and submissions through structured evidence exports and control coverage reports, including OSCAL/OpenControl exports for regulator submissions, executive scorecards for compliance posture, and audit trails with mapping rationale for inspectors.

Reported Outcomes

• 30% faster release cycles
• 50% reduction in audit findings
• Reduction in inspection preparation time from weeks to days, as reported by a VP of Quality at a medical device manufacturer

The platform is described as validated for regulated environments and integrates natively with CI/CD pipelines. It supports shift-left compliance controls and release gating, and produces structured exports in formats including OSCAL and OpenControl for use in regulatory submissions.