Quality Management Software for Life Sciences

For businesses in life sciences and healthcare, the need to maintain a high level of regulatory compliance is paramount to success. EtQ has developed a leading QMS solution that provides a holistic and scalable solution for automating processes, integrating business systems and fostering collaboration and continuous improvement.

Download Guidebook

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.

Learn More
Quality Management Software for Life Sciences

How are Companies Fostering and Managing Regulatory Compliance in Life Sciences?

Quality Management for Life Sciences

In the Life Sciences market, there is an increasing level of oversight and regulation that drives companies to ensure they are meeting the requirements to stay in line with GMP (Good Manufacturing Practice) standards, FDA regulations, and global initiatives. There is also an increased complexity in many organizations, within the supply-chain and globalization, which makes compliance management a challenge. The more complexity, the harder it is to maintain compliance, yet compliance becomes more tied to brand equity, consumer confidence and overall profitability. Companies are looking for a way to benchmark compliance, improve processes and keep up with the pace of business. Automation through QMS software is helping to drive this change.

Life Science Compliance and Quality Management Solutions

EtQ Reliance compliance management software solution was purpose-built to help address the challenges facing life science organizations. With over 20 modules, the solution provides a seamless, integrated solution for managing compliance from event detection to event correction and beyond. EtQ provides a flexible platform that enables organizations to configure processes for compliance management such as complaint handling, nonconformities, corrective action, document management, training, change management and more. These interconnected, configurable modules help to provide a global view on compliance, and enable companies to control their operations throughout the enterprise.

Gain Visibility and Control.

Quality Management in the Life Sciences 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
compliance software

Accelerate Time to Value with Industry Best Practice Processes.

EtQ has built its Life Sciences QMS system with over 20 processes related to Quality and Compliance. This allows you to leverage a foundation to configure to meet your unique business needs.

Comprehensive set of over 20 Modules including:

  • Document Control
  • Corrective Action
  • Audit Management
  • Nonconformances
  • Specification Management
  • Change Management

How are Organization Creating a Clearer Picture of Regulatory Compliance?

Regulatory Reporting & Inspection Readiness

The biggest challenge facing organization is reporting on compliance, and EtQ’s compliance management software solution was designed to foster regulatory reporting. One key area is inspection readiness and compliance audit management, in which the organization is able to show traceability of events in the event of an FDA or regulatory inspection. EtQ provides comprehensive compliance audit solution and event history reporting, enabling organizations to generate a report on adverse events from start to finish. Furthermore, companies need to report to FDA directly for any adverse event. Through EtQ, you are able to generate FDA medwatch forms and create eMDR reports to automatically submit to the FDA.

Risk Management and Enterprise Reporting

Risk management and risk reporting is an increasing component to regulatory compliance. Through EtQ’s reporting platform, you can conduct quantitative risk analysis, and generate risk-based and operational reports, with drill down capabilities. Furthermore, using EtQ's Analytics engine, you can run reports on multiple operational areas, multiple processes, and across different modules. This granular reporting allows for increased trending on data, leading to more proactive reporting across a deeper level of analysis. This enables organizations to make sense of their compliance data, assess their top risks, and take action to continuously improve their overall compliance.

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.

  • "EtQ has been able to solve our business need as it provided us with a very flexible tool set that would allow us to configure workflow solutions in a timely manner that would meet our needs and requirements."

    − Director of Quality, Medical Device Manufacturer
  • "The cost savings and cost avoidance from employee productivity gains in combination with the increased sales that are a direct result of the increased customer satisfaction, along with the $200,000 cost avoidance from not having to fix the old system or replace it with licensing of another tool are expected to provide an ROI of at least 700% in the first year alone."

    − Quality Director, Consumer Products Company
  • "we now have a central location where information is now available and we can assure accuracy versus having several spreadsheets that needed to be maintained manually were accuracy was not always 100% and the information was not easily accessible. "

    − Executive Director, Regulatory Affairs, Global BioMedical Organization
  • "The common platform allows for real time collaboration on issues, containment and corrective actions globally that we were never able to do before with the segregated solution. "

    − VP of Continuous Improvement, Pharmaceutical Company

High Level Compliance Features.

Flexible Workflow Platform.

EtQ pioneered the concept of flexible workflow, which enables the user to configure the workflows, forms, sections, fields and keywords, without programming. Furthermore, this enables companies to continually adapt the process to their unique business needs and compliance requirements.

Learn More

gmp compliance

Role-based Compliance Dashboard.

EtQ's Portal provides a centralized, role-based compliance dashboard to see all relevant information in your compliance system. From the portal you can see:

  • Key Performance Indicators (KPI)
  • My Assignments
  • Favorites (Documents, Reports, Applications, etc)
  • Charts and Views
  • Saved Reports

Learn More

regulatory compliance software

Make Sense of your Compliance Data.

EtQ has built-in reporting and business intelligence tools to help you drill-down on compliance data, and more better, more informed decisions. Charting, Exception Alerts, and user-defined analytics — all through EtQ.

Watch Video

compliance management software

Keep in Compliance.

EtQ features full compliance to 21 CFR Part 11, Electronic Signatures and Records, including:

  • Electronic Signature Binding: EtQ automatically and securely binds the authenticated user's electronic signature.
  • Audit Trail: EtQ securely and automatically posts any and all field changes to a separate database.
  • Controlled / Secure Access: EtQ’s robust security model ensures your system and data have the highest security.
  • Enhanced Password Security: Automatic password aging with configurable expiration and warning periods, as well as automatic protection against repeated attempts to log in.
  • Comprehensive Validation Services: EtQ’s Validation Services is based on a phased approach that integrates the traditional V-Model with the Risk-based approach per GAMP5.

Learn More

Want to see more on how EtQ can help you streamline your Compliance System? Take a live demo