Product/Service

Medical Device Software

Source: EtQ, Inc.
Medical Device Software- EtQ for Medical Device is an integrated quality and compliance management software system that has been pre-configured to specifically address the needs of the Medical Device industry, and exceed 21 CFR Part 11 requirements.

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Brochure: EtQ Reliance
Datasheet: EtQ For Life Sciences - Available Modules
Flash Diagram: EtQ For Medical Device

Integrated Quality System
Medical Device Software- EtQ for Medical Device is an integrated quality and compliance management software system that has been pre-configured to specifically address the needs of the Medical Device industry, and exceed 21 CFR Part 11 requirements. EtQ's unique modular approach provides unparalleled flexibility and automation. The modules are tightly integrated to deliver a best-in-class CAPA solution.

Connected to the Production
Medical Device Software- EtQ Connectors close the gap between production systems and the quality system. Modules like NCM and Complaints 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 investigation results.

Advanced Filtering of Events
Medical Device Software- EtQ's unique CAPA 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
  • 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 CAPA
Medical Device Software- The EtQ Reliance for Medical Device CAPA system is pre-configured to initiate various post-CAPA processes, including electronic distribution of CAPA results, Change Management, and Employee Training.

eValidation
Medical Device Software- 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.

Click Here To Download:
Brochure: EtQ Reliance
Datasheet: EtQ For Life Sciences - Available Modules
Flash Diagram: EtQ For Medical Device