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Always Be in Compliance with EtQ's Solution for GMP Regulatory Compliance.


In today's market, the need to maintain a high level of compliance is paramount to success. EtQ has developed a leading GMP Compliance Software solution that provides a holistic and scalable solution for automating processes, integrating business systems and fostering collaboration and continuous improvement.

 

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Automate Processes, Save Resources.

 

Through EtQ, customers are able to improve efficiency and streamline their processes. On average, companies that implement EtQ are able to save time to generate and route adverse events—an average of 3 full-time resources—resources you can instead focus on more value-added activities.

Gain Visibility and Control.

 

 

Compliance can be boiled down to visibility and control. You want to control your processes, automate and manage them. You also want to have visibility into the data, be able to provide traceability into adverse events and quickly report on the data.

 

  • Reduce the time needed to resolve adverse events
  • Centralized location that provides a single point to review all events
  • Visibility needed in order to take immediate action
  • Quantitative Risk Filtering provides objective measuring of events
  • Real-time Reporting and Analytics provide visibility into the data

 

 

Learn More about Risk Management


Accelerate Time to Value with Industry Best Practice Processes.


EtQ has built its Quality Management solution on a foundation of over 20 best practice modules, which enables you to leverage and configure processes to meet your needs. All modules meet common standards for ISO 9000 and similar initiatives for your business.


  • Document Control
  • Corrective Action
  • Audit Management
  • Nonconformances
  • Specification Management
  • Change Management
  • Complaint Handling
  • eMDR
  • Employee Training
  • Supplier Management
  • And more!

 

 

See a list of all of our modules


Traceability of Adverse Events, from Start to Finish.
EtQ's solution allows you to integrate modules so that data is automatically inherited throughout the process. You can launch CAPAs from any adverse event, and have the data traced back to its source. This way, you can view the entire history of an event, from the moment it was recorded to the moment it was resolved.

Making Compliance a Competitive Advantage for GMP Software

GMP Compliance Software for Life Sciences

EtQ's GMP Compliance Software for Life Sciences is an integrated quality management and FDA Compliance Software system that exceeds GMP standards, including ISO 13485, ISO 14791 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 GMP Compliance Software solution that will improve compliance and quality for your industry.

Connected to the Production Systems

EtQ Connectors close the gap between production systems and the quality compliance system. Modules like Nonconformance Management 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 Quality and Compliance Management Software is designed to minimize the number of Corrective Actions 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 ctions
  • Comprehensive CAPA action and effectiveness check plan with risk mitigation history

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) directly through the FDA's automated Gateway using EtQ eMDR. 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.
Read More on eMDR
Download eMDR White Paper

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.
Read More on eValidation

Closed Loop Corrective Action

EtQ's GMP 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.
Read More on CAPA
Download CAPA White Paper

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 Complaint Handling to identify adverse events, analyze change feedback and collect customer requirements for future changes.

Visibility into all Quality and Compliance Processes

EtQ integrates data from multiple business systems to ensure a high level of compliance and quality for your organization.

  • Reduce the time and cost of dual-entry by pulling data from existing production systems
  • Eliminate the quality and compliance gap by automatically converting defects identified in production systems into workflow based events in EtQ
  • Prevent poor data quality by selecting from existing data in external systems.
  • Shorten inventory cycles by increasing efficiency of quality investigations in releasing products put on hold in production systems
  • Minimize risk in product releases by scanning systems for open quality issues prior to release

Advanced GMP Compliance Software System Methodology for Life Sciences

Implementing different Quality Management applications to GMP 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 Life Sciences industry.