Driving excellence through quality

What is ETQ Reliance QMS?

ETQ Reliance is a cloud-native quality management system (QMS) used globally by more than 600 companies to manage quality and identify issues that can impact quality. It offers built-in best practices and powerful flexibility to drive business excellence through quality.

QMS software automates the functions of manual quality management processes. By automating quality processes within audits, documentation, Corrective & Preventive Actions (CAPA), complaints handling, nonconformance management, safety, training, and supply chain management, companies can better meet quality and compliance goals and regulatory requirements.

What are the main ways it benefits medtech manufacturing?

ETQ Reliance helps medtech manufacturers meet regulatory compliance requirements and boost quality across their operations. It digitizes and automates paper-based production processes, capturing the critical data and insights needed to optimize production, reduce deviations, and take corrective/preventive actions. It also accelerates the pace of new product introductions.

An advanced QMS for medical devices offers compliance with regulatory standards such as current Good Manufacturing Practices (cGMP), 21 CFR Part 11, and Annex 11 and ISO: 13485, eMDR electronic form submission and more effective system validation.

Maintaining compliance while fostering innovation at the speed required to compete on a global scale requires streamlined, agile quality processes that quickly close the loop on medical device quality challenges.

What range of applications are available?

• Document control
• Audit management
• Complaints handling
• Corrective & Preventive Action (CAPA)
• Nonconformance management
• 21 CFR Part 11
• Production part approval process
• Supply chain quality

Specific applications, such as ETQ Reliance’s Complaints Handling give medtech companies comprehensive control over how customer complaints are handled, recorded, reported, and tracked in compliance with U.S. Food and Drug Administration (FDA) guidelines. It gives them complete and accurate information to track all parties involved in the complaint (customers, suppliers, specific products, partners) and then use that data to mitigate and prevent future complaints.

Reliance also offers a MedWatch form for Electronic Medical Device Reporting (eMDR) that complies with the Health Level 7 (HL7) individual Case Safety Report (ICSR) option.

Additionally, ETQ’s most recent Lab Investigation application allows companies to efficiently track, trend, and resolve problems identified in laboratory testing. The application automates the documentation process for out-of-specification (OOS) and out-of-trend (OOT) lab test results, helping determine the root cause and issue a non-conformance or CAPA if necessary.

What role does ETQ Reliance QMS have in improving key performance indicators (KPIs)?

It helps track progress toward meeting critical quality benchmarks, and tracking is the first step toward continuous improvement. Tracking quality throughout the organization also allows users to pinpoint areas coming up short. This gives users the opportunity to address production challenges, reduce risk, and create better products, faster.

Simple mistakes can cost medtech manufacturers millions of dollars in revenue and time spent resolving problems. When considering the crucial role of lab work in bringing products to market, it becomes clear just how vital quality management is to the product life cycle.

ETQ Reliance helps companies meet internal key performance indicators (KPIs) for quality and safety, as well as external regulatory requirements. Even if customers aren’t actively thinking about quality daily, their purchases and brand loyalty are directly tied to the quality of products and their experiences, so quality management is crucial.

Since adopting ETQ Reliance, one customer saw drastic improvement in its KPIs: a 50% reduction in CAPA resolution time and a 40% reduction in document revision time.

How does the system facilitate audit management, CAPA, and nonconformance management?

Preparing for an audit can be challenging – whether it’s an internal or external audit. ETQ Reliance helps medtech manufacturers get access to all audit components from anywhere, in a single, centralized system. It also allows them to configure and execute specific checklists, more easily manage the entire quality audit process, and generate comprehensive audit reports.

CAPA is required in life sciences. ETQ Reliance helps firms address adverse events, such a nonconformance, customer complaint, or internal audit, and lay the foundation for root-cause analysis. CAPA software and procedures play a key role in regulatory compliance and the prevention of recurring quality issues.

ETQ Reliance’s nonconformance management capabilities enable management and tracking of nonconformances to ensure that product defects are flagged and handled properly. It helps identify any materials that don’t conform and the areas to act on and properly disposition the material. It also enables companies to open and begin an investigation to determine the root cause. Once located, it builds out a scheduled plan to fix it, and it doesn’t stop until it has verified correction effectiveness.

Does ETQ Reliance QMS facilitate the production part approval process (PPAP)?

Yes. ETQ Reliance enables companies to improve overall supplier quality, offering a consistent and repeatable process for approving parts from suppliers. While PPAP was originally created for the automotive industry, life science firms are finding that it plays a role in managing supplier quality. It’s giving them complete visibility into supplier performance by accessing supplier information from other ETQ Reliance apps such as Life Sciences Compliance, Receiving and Inspection, Nonconformance Management, Supplier Corrective Action Request (SCAR), Change Management, and others.

Are there other processes the system automates?

It helps automate validation, which is critical in life sciences, pharma, and medical device manufacturing. ETQ Reliance and its solutions make this mandatory process much faster and more efficient. Two levels of validation support and services reduce the time and expense associated with validation.

Additionally, the automated document control system helps organize documents and offers automated workflows to make corresponding updates to any related documents.

ETQ Reliance has 40 applications that can be adapted to any medtech manufacturer’s specific needs.

Does the system integrate with other enterprise applications?

ETQ Reliance enables companies to drive synergy throughout the enterprise by leveraging corporate data that exists in other systems, such as enterprise resource planning (ERP), manufacturing execution system (MES), product lifecycle management (PLM), and lean management systems (LMS) solutions. Companies can integrate with other enterprise applications to share data, streamline data entry, reduce errors, automate cross-functional workflows, and have a single source of truth for quality information.

Additionally, internal and external parties can seamlessly and securely contribute to common QMS workflows in the cloud.

What are some examples of how ETQ has helped medtech manufacturers with regulator and quality challenges?

A leading provider of medical devices made the decision to adopt the Medical Device Single Audit Program (MDSAP), which allows manufacturers to conduct a single regulatory audit of their QMS to satisfy the requirements of multiple jurisdictions. As an early adopter of MDSAP, the company needed to revisit its quality management strategy and processes to ensure compliance and quality excellence. They designed a unique audit management module for MDSAP using ETQ Reliance that meets the needs of all five jurisdictions.

Additionally, a biotech firm was initially looking for a turnkey QMS to replace manual processes and support them – from preclinical and clinical trials, through to commercialization. ETQ Reliance has helped them reduce the paperwork for processes because everything is linked. For example, CAPA is linked to Quality Records and to Test Validation, resulting in a seamless process. The solution has reduced the number of paper forms and has sped up the inspection process by enabling the company to enter data directly into the system rather than filling out paper forms that are then manually entered into the system.

In another example, a leading provider of high-quality surgical instrumentation and devices needed to adhere to changing FDA and other regulations while simultaneously protecting its brand value. They initially implemented ETQ Reliance’s Document Control application, then quickly identified other areas where ETQ could help. During the next several years their quality team implemented a variety of ETQ Reliance applications and successfully standardized quality processes and documentation across the entire product life cycle, helping them maintain compliance with ISO 9001, FDA regulations, and the European Union’s Medical Device Regulation (EUMDR). Additionally, Reliance provides them with quality analytics to help make data-driven decisions to maximize profitability while improving overall supplier quality.

About the author: Elizabeth Engler Modic is editorial director of GIE Media’s Manufacturing Group of magazines. She can be reached at emodic@gie.net.

ETQ
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