BURLINGTON, Mass., November 3, 2020 – ETQ, the leading quality management system (QMS) provider, today announced the availability of several enhanced solutions for customers whose QMS must be validated to meet regulatory agency mandates. Each solution is designed to minimize the disruption and effort required of an organization to comply with validation standards while maintaining operational productivity.
ETQ’s validation products for life sciences and other regulated industries are based on a “least burdensome approach” that is fully aligned with regulations and industry guidance, such GAMP5, to offer a comprehensive solution. Because ETQ Reliance is built on a flexible, scalable and secure SaaS architecture, expediated validation of a customer’s QMS can be performed more efficiently and with less disruption to day-to-day activities when compared with manual or paper-based approaches.
ETQ customers have a choice of three methods of validation to choose from depending on their specific quality environment and in-house team capacity.
1. Self-validation using ETQ’s validated platform and documentation
ETQ employs agile development practices to enable faster response times to regulatory changes and technology trends. For each release of the product, ETQ provides all the necessary documentation to show evidence that the system platform capabilities are thoroughly tested. ETQ Reliance is certified to the ISO 9001:2015 and ISO 27001:2013 standards. As part of our software development cycle we make sure that our releases are tested and validated. Included as part of the Life Sciences solution is the ETQ Reliance Validation Execution Package that shows our robust development, testing and documentation approach for our platform and out-of-the-box (OOB) configurations. Customers who choose this “DIY” style of validation are provided with a complete set of documents and artifacts to support their own validation activities.
2. Cooperative validation with ETQ’s Validation Toolkit
Building on ETQ Reliance’s strength of being the most configurable QMS in the market, customers who have taken advantage of this capability may need to work together with ETQ to streamline validation. The optional ETQ Validation Toolkit is just the answer for this scenario and provides procedural and validation templates required for an organized review a customer’s validation process. The Configuration Specifications template allows customers to model planned configuration changes and then verify these changes with the Configuration Test Script. The Requirement Specification template reflects ETQ’s validated out-of-box application and can be updated to document system requirements and intended use. The pre-filled Risk Assessment template helps apply a risk-based approach to assess the new requirements and features with a focus on any direct impact on patient safety and product quality, given the level of coding complexity in a configured solution. The Requirements Testing template can be updated to test a customer’s specific application configuration and intended use. The complete Reliance Validation Toolkit includes a broad range of tools to augment customers’ validation processes.
3. Use ETQ’s team of validation experts to manage the complete process
ETQ also offers validation services from our team of expert validation consultants. This services approach is risk-focused and based on current regulatory requirements and helps customers remain compliant without duplicating effort. As customers configure and update ETQ Reliance, they need to ensure validation of each change. The ETQ Validation Consulting team can help by supporting and documenting changes, minimizing risk and ensuring controlled change management and traceability. ETQ also provides new release impact assessments that highlight new software features that could potentially impact validation status and documents the assessment and regression testing of the ETQ Reliance platform. The team provides a set of validation services artifacts with the results of each validation cycle.
ETQ’s validation offerings help customers manage their complete validation needs easily and cost-effectively – without the need to bring on additional staff or third-party consultants. With ETQ’s comprehensive industry experience, product knowledge and deep validation expertise, customers can manage the cost of validation while improving time-to-value of regularly validated systems.
ETQ is the leading provider of quality, EHS and compliance management software, trusted by the world’s strongest brands. More than 570 global companies, spanning industries including pharmaceuticals, electronics, heavy industry, food and beverage, and medical devices, use ETQ to secure positive brand reputations, deliver higher levels of customer loyalty and enhance profitability. ETQ Reliance offers built-in best practices and powerful flexibility to drive business excellence through quality. Only ETQ lets customers configure industry-proven quality processes to their unique needs and business vision. ETQ was founded in 1992 and has main offices located in the U.S. and Europe. To learn more about ETQ and its various product offerings, visit www.etq.com.
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