ieQip

AI-powered FDA compliance audits and intelligent inspection platform

ieQip® (Intelligent Electronic Quality Inspection Platform) is an AI-powered quality and regulatory compliance platform developed to help life science organizations conduct efficient, consistent, and audit-ready inspections.

Built for pharmaceutical, biotechnology, medical device, dietary supplement, cosmetic, food, and related regulated industries, ieQip assists quality professionals in performing mock FDA inspections, internal audits, supplier assessments, and due diligence reviews while maintaining complete control of their confidential information.

Key Features

• AI-powered audit assistance for faster and more consistent inspections

• Generate mock FDA-483 observations and Establishment Inspection Reports (EIR)

• Conduct internal audits and third-party supplier assessments

• Identify compliance gaps and quality system weaknesses

• Standardize audit processes across multiple facilities

• Support CAPA and continuous quality improvement initiatives

• Secure enterprise deployment that allows organizations to retain full ownership and control of their audit data

• Designed for use by quality assurance, regulatory affairs, compliance teams, consultants, and internal auditors

Enterprise Solution

ieQip can be licensed directly to organizations, allowing companies to perform audits internally or through approved auditors while ensuring all inspection data remains under the organization's control. This reduces reliance on external systems and helps protect sensitive quality and regulatory information.

Who Uses ieQip?

• Pharmaceutical manufacturers
• Biotechnology companies
• Medical device manufacturers
• Dietary supplement manufacturers
• Food and cosmetic manufacturers
• Quality Assurance (QA) professionals
• Regulatory Affairs teams
• FDA compliance consultants
• Internal and third-party auditors

Whether you're preparing for an FDA inspection, strengthening your Quality Management System (QMS), or improving audit efficiency, ieQip provides intelligent tools that help your team identify risks earlier, streamline inspections, and maintain regulatory compliance.