Making Compliance a Competitive Advantage
Integrated FDA cGxP/GMP Compliance Software System
EtQ's FDA cGxP/GMP Compliance Software for Life Sciences is an integrated quality management and FDA compliance software system that has been pre-configured to specifically address the needs of the Life Sciences industry, and exceed cGxP/GMP standards and 21 CFR Part 11 compliance requirements. EtQ's unique modular approach provides unparalleled flexibility and automation. These modules are tightly integrated to deliver a best-in-class FDA Compliance Software solution.
Connected to the Production Systems
EtQ Connectors close the gap between production systems and the quality system. Modules like Nonconformance Management Software and Complaint Handling Software connect to ERP and CRM systems to fully automate the creation and assignment of events. Production systems can then be automatically updated throughout the event resolution process. For example, to trigger the release of product based on the MRB disposition; or update the complaint status based on the CAPA investigation results.
Advanced Filtering of Events
EtQ's unique FDA Compliance Management Software System is designed to minimize the number of CAPAs using an advanced filtering model:
- Automatic segregation and categorization of events at the source
- Automatic identification and display of related events
- Built-in Risk Assessment Software module
- Initial assessment to allow early closure
- Risk Assessment throughout the process to guide decision making
- Full investigation with step-by-step root cause analysis
- Automatic lookup and display of related investigations and corrective actions
- Comprehensive CAPA action and effectiveness check plan with risk mitigation history
Change Management
EtQ's Change Management module is designed to manage all aspects of the Change Management process. EtQ's Change Management module integrates with other key modules such as Risk Assessment to analyze the impact of change, and Complaints Handling to identify adverse events, analyze change feedback, and collect customer requirements for future changes.
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Closed Loop Corrective Action
EtQ's FDA Compliance Software for Life Sciences is pre-configured to initiate various post-CAPA processes, including electronic distribution of CAPA results, Change Management, and Employee Training.
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eValidation
EtQ offers an automated validation module that will shorten the validation process from weeks to minutes. EtQ's unique eValidator™ comes preloaded OQs and PQs for all the pre-configured modules.
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Electronic Submissions to the FDA (eMDR) using EtQ MedWatch Plus Tool
EtQ Reliance eMDR Submission Tool enables Medical Device Manufacturers to electronically submit Medical Device Reports (MDRs) to the Food and Drug Administration (FDA) directly through the FDA's automated Gateway using EtQ MedWatch Plus. This methodology allows companies to electronically automate the quality process for medical device, and comply with quality and compliance standards, including those of the FDA.
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Advanced Quality Management System Methodology for Life Sciences
Implementing different Quality Management applications to FDA Compliance is costly, time-consuming and confusing to users. With all its functionality built around a common platform, EtQ has developed a Management System that unifies both quality and FDA compliance processes in the Medical Device industry: