cognidox

Digitises document control with version control, metadata indexing, configurable approval workflows, and audit trails to ensure systematic document governance.

Supports phase gating and design validation processes to document and control the entire design lifecycle, enabling real-time assembly of FDA technical documentation.

Integrates FDA 21 CFR Part 11 and ISO 13485 compliant electronic signatures into workflows for regulatory compliance.

Provides integrated training tools including skills matrix, self sign-off, quizzes, and trainer assessments to streamline onboarding and compliance.

Manages corrective and preventive actions, complaints, and non-conformance reports to detect, correct, and prevent quality failures.

Monitors and manages supply chain quality to ensure vendor compliance and oversight.

Facilitates controlled change processes critical to quality and regulatory compliance.

Offers graphical oversight and control of quality and business processes to support continuous improvement and audit readiness.