Medical DeviceQualified Supplier Directory

EtQ, Inc.

399 Conklin St., Ste. 208
Farmingdale, 
NY  11735  us
Tel: 800-354-4476
Fax: 516-293-0784

Integrated FDA Compliance Management Software System

EtQ's solution for Life Sciences is an integrated quality and FDA compliance management system that has been pre-configured to specifically address the needs of the Life Sciences industry, and exceed 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 Customer Complaint Handling 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 a product based on the MRB disposition; or update the complaint status based on the Corrective and Preventive Action (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 CAPAs
  • Comprehensive CAPA action and effectiveness check plan with risk mitigation history

 

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.

 

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.

 

Electronic Submissions to the FDA (eMDR)

EtQ Reliance eMDR Submission Tool enables Medical Device Manufacturers to electronically submit Medical Device Reports (MDRs) to the Food and Drug Administration (FDA). 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.

 

 

Resources

 

GUIDEBOOKS

The Life Sciences Guidebook: Selecting, Implementing, and Using FDA Compliance Software Solutions

 

WHITE PAPERS

Managing Your Risk Has its Rewards: Making the Case for Risk Assessment in Streamlining your Quality and Compliance Processes
Beyond CAPA: Using Risk Assessment to Streamline your Quality System
Pharmaceutical Compliance that Spans the Supply Chain: Considerations for Extending the Quality

 

BROCHURES

EtQ for Life Sciences
EtQ Quality Management Software
Deploying EtQ’s Cloud Solution in a Regulated Environment

 

CASE STUDIES

Virginia Blood Services
For Virginia Blood Services, automation has become a catalyst for enhancing business processes, and quickly recognized the need for an automated Quality Management System (QMS) that could be easily adapted to best suit the organization's unique business needs. Their decision was made to seek out a fully automated QMS. After comparison with various vendors, EtQ Reliance surfaced to the top and was selected as its automated QMS.