Free for unlimited users and records. Forever.
Manage Supplier Quality locations, contracts, expiring certificates, and more. Approve and Evaluate Suppliers using a real 21 CFR Part 11-compliant electronic signature cycle.
Manage all types of audits electronically for only $10/user/month. Includes intelligent, optional links from Suppliers module. Eliminate forms. Build Audit Plans and Audit Reports from the browser. Generate CAPAs directly from findings and close Audits with electronic signatures.
Start processing electronic CAPAs. Immediately. Built for and validated to ISO 13485:2016 and 21 CFR Part 820. Pre-built, time-saving Containment, Investigation Root Cause, Correction, Corrective Action, and Preventive Action activities. Risk aware and verification ready.
Free for unlimited users and records. Forever.
Electronically track customers. Comply with EU MDR requirements. Form and record agreements and contracts. Link Customers to Feedback records.
Complaints Module
Collect and recall product, conduct investigations and root cause analyses, perform corrections, notify external parties, determine reportability.
Free for unlimited users and records. Forever.
Electronically track organization Nonconformance. Includes Scope, Investigations, Dispositions, and more. Intelligent, suggested Links to CAPAs. Resolve and close NCs with electronic signatures.