Complaints Handling Application
ETQ Reliance’s Complaints Handling application allows life sciences companies to manage the investigation and resolution of regulatory complaints in compliance with FDA guidelines. This comprehensive system provides control over how customer complaints are handled, recorded, reported, and tracked. By leveraging complete and accurate information, companies can track all parties involved in complaints and use the data to mitigate and prevent future issues.
Automated E-Signature Tracking for Compliance
Meeting the requirements of 21 CFR Part 11 and Annex 11 can be complex for companies in the life sciences sector. ETQ offers compliant software with electronic signature capture capabilities, built-in audit trails, and validation support. This closed system automates the process of associating secure electronic signatures with electronic records, ensuring compliance and simplifying management, tracking, and reporting.
QMS Validation Solutions
Validation is crucial for life sciences, pharmaceutical, and medical devices companies. ETQ provides validation solutions that make this mandatory process expedited, efficient, and hassle-free. With two levels of validation support and services, ETQ reduces the time and costs associated with validation, enabling companies to meet regulatory requirements effectively.
Turning Compliance into a Strategic Advantage
ETQ Reliance empowers life sciences companies to turn compliance requirements into a strategic advantage. From meeting computer system validation requirements to electronically submitting to the FDA (eMDR), ETQ Reliance offers a range of applications that streamline processes and enhance compliance efforts. By validating configurations in a separate environment before production, companies can ensure quality and compliance.
Discover Other ETQ Reliance Application Sets
In addition to Compliance, ETQ Reliance offers various application sets such as New Product Introduction, Supply Chain Quality, Nonconformance Handling, Health & Safety, Environmental Management, and Enterprise Risk Management. These applications work in synergy to provide comprehensive quality management solutions for life sciences companies.
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