Description
Key Features and Benefits
- Document Management & Compliance – Manages the full document lifecycle with version control, automated notifications, and secure eSignatures.
- Training Management – Tracks SOP reviews, certifications, and on-the-job training with automatic reminders.
- CAPA & Issue Management – Customizable closed-loop workflows for deviations, complaints, and CAPA tracking.
- Change Control – Ensures structured and auditable organizational changes with approval workflows.
- Audit Management – Helps with supplier qualification, internal/external audits, and risk tracking.
- AI-Driven Insights & Analytics – Provides trend analysis, compliance reports, and real-time dashboards for continuous improvement.
- Integrated eSignature (ZenSign) – Built-in, validated eSignature tool for Part-11 compliance without requiring DocuSign or Adobe Sign.
Key Differentiators
- Fixed-Pricing Model – One price includes ALL modules and unlimited users—no hidden fees.
- Purpose-Built for Life Sciences – Designed for pharmaceutical, biotech, and medical device companies.
- Highly User-Friendly – Simple interface that reduces complexity while maintaining compliance.
- Validated & Audit-Ready – Pre-configured to meet FDA and ISO standards, with GxP compliance tools.
