Assure-IQ

Assure-IQ is a robust Quality Management System (QMS) tailored for the pharmaceutical and regulated industries. It facilitates streamlined processes, accelerates decision-making, and ensures regulatory compliance. By integrating with Caliber's Document and Training Management systems, it guarantees quality excellence throughout the product lifecycle.

Designed to adapt to diverse needs, Assure-IQ offers over 30 modules, allowing users to customize a platform that fits their specific requirements. It supports both on-cloud and on-premise deployments, utilizing the latest technology to meet evolving industry demands. This flexible QMS integrates seamlessly with existing company systems, setting a new benchmark for quality success.

Assure-IQ is highly configurable, enabling enterprises to replicate their processes within the system through workflow-based configurations. It supports multiple business rules with conditions and actions, ensuring a seamless fit with existing processes.

Key Features

• Audit Management: Manage internal and external audits with comprehensive tools for scheduling, tracking, and monitoring.
• CAPA: Identify and correct process errors at their root to prevent recurrence, supported by trend analysis.
• Deviation Control: Optimize and regulate unplanned deviations to maintain product consistency and compliance.
• OOS and OOT Management: Automate data logging and SOP matching within a single system for efficient out-of-specification and out-of-trend management.
• Reports & Analytics: Utilize configurable dashboards and analytics for actionable insights and decision-making.
• Pharmacovigilance: Ensure product safety with regular QA responses and comprehensive case management.

Assure-IQ ensures ongoing quality and GxP focus, meeting regulatory standards such as 21CFR Part 11, cGMP, GxP, FDA regulations, ISO 9001:2015, and ALCOA+ compliance. It integrates seamlessly with other systems, including ERP and directories, and supports centralized quality management with Caliber's product suite.

The system's configurable workflows simplify complex quality processes, adapting easily to business demands. Assure-IQ also guarantees data integrity through encryption and automation, adhering to ALCOA Plus principles.

Integration with Docs-IQ allows for streamlined document management, including SOP management and document versioning, ensuring regulatory compliance. Additionally, integration with Learn-IQ and CaliberBRM helps manage deviations during manufacturing, enhancing both efficiency and quality control.