Why do companies prefer CQ’s Regulatory Document Management Tools?
CQ's software suite is meticulously designed to meet the highest regulatory standards. Our tools are pre-validated and fully compliant with GxP Guidelines, FDA 21 CFR Part 11, and ISO 13485:2016, ensuring the utmost quality and security.
Our regulatory document management is seamlessly integrated into our all-in-one Quality Management System (QMS) software, which encompasses essential modules like document control, change control, audits, non-conformances (NCs), corrective and preventive actions (CAPAs), supplier management, training, and more. We handle system implementation, provide comprehensive training, and offer ongoing support to guarantee the smooth operation of our software.
What sets us apart is our commitment to continuous re-validation, a service not commonly offered by other providers. We deliver robust validation evidence for audits and inspections, including validation plans, procedures, reports, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documentation.
Key features of CQ's Regulatory Document Management Tools encompass controlled document workflows, detailed version control and document history tracking, user access controls with permissions management, a complete audit trail of document changes, a centralized and cloud-based repository for easy document search and retrieval, compliant electronic signatures adhering to FDA 21 CFR Part 11, extensive support for various QMS processes, seamless integration with third-party software applications, and the flexibility to access documents from any device. Our software is tailored to meet your compliance and document management needs efficiently and effectively.