AI-Powered Compliance Platform
The complete Compliance platform. Manage standards, Validation coverage, Procedures, Controls, training, and automation—all in one integrated suite.
Everything you need for regulatory validation and compliance visibility
Core compliance platform with AI-powered test generation and complete audit trails.
Regulatory updates feed – stay ahead of standards and revision changes. Free to view; unlock impact on your tests and procedures with Helm Hub.
Need a standard or regulatory body added? Request it and we'll consider it for future updates.
Automated test scripting and validation delivery with dedicated support.
Regulatory Updates – Stay Ahead of Standards & Revisions
Helm Watch keeps you informed on regulatory standards and revision changes. View the live feed free of charge; integrate with Helm Hub to see which of your adopted standards are affected and which tests and procedures need attention.
See current and upcoming revisions for key regulatory standards (e.g. FDA, ICH, ISO). Each standard shows published versions and drafts or in-review versions so you can plan updates in advance.
No change (green), updates required (amber), or major changes (red) per standard. Quickly prioritise which revisions need your team’s attention and when.
Curated list of regulatory bodies and standards monitored by Helm Watch. Expand any row to see version details, summaries, and effective dates.
Data is kept up to date from authoritative sources. No static PDFs – you see the latest revision status as it becomes available.
What you get without an account, and what you get when you use Helm Watch with Helm Hub.
Need a standard or regulatory body added? Request it and we'll consider it for future updates.
Your Central Compliance Command Center
Helm Hub transforms manual validation into an automated, AI-powered process. Generate comprehensive test cases in minutes, maintain perfect audit trails, and achieve regulatory compliance—all from one integrated platform.
Save 40+ hours per project. Revolutionary AI-powered test generation. Input your requirements and watch as the system generates comprehensive test cases, execution steps, and expected results—complete with regulatory traceability.
Pre-loaded library of FDA 21 CFR Part 11, GAMP 5, ICH Q7, ISO 13485, and more. Organise by requirements, map to your tests, and maintain full traceability for audits.
Visual coverage dashboards show gaps at a glance. Link test cases to specific regulatory requirements for complete traceability. Generate coverage matrices for FDA inspections.
Complete document management with version control, approval workflows, tree-structured Organisation, and automatic archiving of superseded documents. Full audit trail for all changes.
Built-in electronic signatures, tamper-evident logging with cryptographic hash chains, time-stamped audit trails, and user access controls meeting all FDA requirements out of the box.
Professional PDF reports with comprehensive audit trails. Export test execution records, coverage matrices, traceability reports, and validation master plans for regulatory inspections.
Granular permissions: Super Admin, Org Admin, Compliance Manager, Test Engineer, Auditor, and Viewer roles. Control who can create, execute, approve, and view validation documentation.
As a Compliance consultant have a single view and permissions across all your client Organisations.
Perfect for consultancies or multi-site Organisations. Complete data isolation between Organisations, with optional cross-Organisational visibility for enterprise deployments. Single Tenant available, please contact us for more information about individual requirements.
Transform Manual Validation into Automated Workflows
Our Compliance Automation Service delivers professional test automation that integrates seamlessly with Helm Hub. Focus on compliance strategy while we handle the automation engineering.
Expert automated test scripts using tried and tested frameworks. We handle the complexity—you get reliable, maintainable automated validations that meet regulatory requirements.
Scheduled and on-demand test execution. Run validation suites nightly, on code commits, or triggered by specific events. Get instant notifications of failures and automatic evidence collection.
Test results flow automatically into Helm Hub. Failed tests trigger alerts, passed tests update traceability matrices, and all execution data maintains perfect audit trails for regulatory compliance.
Connect to Jenkins, GitLab CI, Azure DevOps, or any CI/CD pipeline. Validation becomes part of your deployment process, catching compliance issues before they reach production environments.
Smart notifications for test failures, coverage drops, or validation gaps. Configurable escalation workflows ensure critical issues get immediate attention from the right stakeholders.
Your dedicated account manager provides regular check-ins, script optimization, and continuous improvement of your automated validation processes. Priority support with SLA guarantees.
Start your 7-day free trial or schedule a personalized demo
You can also use this form to request a new standard or regulatory body to be added to Helm Watch.