Description
Key Features and Benefits
- End-to-End Compliance Management – Supports CAPA, non-conformance tracking, audit management, and training compliance with deep linking to policies, regulatory events, and SOPs.
- Automated Workflows & Configurable Dashboards – Enables custom workflows, notifications, and tracking for change management and corrective actions.
- Regulatory Document Publishing – Automates the generation of validation artifacts (e.g., user requirements, functional specifications, code review reports) for compliance submissions.
- 21 CFR Part 11 Compliant Electronic Signatures – Ensures audit trail integrity and compliance with FDA and GxP standards.
- Supplier Quality Control & Communication – Provides a single source of truth for supplier evaluations and collaboration through permission-based access.
- Seamless Integration with Industry Tools – Works with Jira, Trello, GitHub, Asana, monday.com, and AutoCAD, making it an ideal choice for software-heavy medical and biotech firms.
Key Differentiators
- Built for Life Sciences & Healthcare – Tailored to biotech, pharma, digital health, and clinical research with GxP and FDA validation support.
- High Customizability – Can be adapted to any business size or life cycle stage, allowing for bespoke configurations.
- Affordable and Scalable Pricing – Startup-friendly pricing model with flexible tiers and no add-on costs for core compliance features.
