Having a robust quality management system (QMS) is essential for ensuring product quality, especially in industries like medical devices. But what exactly is a QMS, and how does Scarlet fit into the picture? Let's dive in.
What is a QMS?
A Quality Management System (QMS) is a structured framework that helps organisations ensure that their products or services meet consistent quality standards. It encompasses all the processes, policies, and procedures necessary to design, develop, manufacture, and deliver a high-quality product. By maintaining high standards throughout the production process, a QMS aims to improve efficiency, reduce risks, and ensure customer satisfaction.
What is an eQMS?
An Electronic Quality Management System (eQMS) is a software platform designed to help organisations manage their QMS processes digitally. eQMS solutions streamline and automate various aspects of quality management, making maintaining compliance with industry regulations easier. Some popular eQMS software includes:
Formwork
Matrix Requirements
GreenLight Guru
Qualio
These tools allow organisations to document processes, track quality metrics, and ensure that all quality-related activities are conducted efficiently and in compliance with relevant standards.
Is Scarlet an eQMS?
No, Scarlet is not an eQMS. Unlike eQMS platforms that help manage and control quality processes, Scarlet focuses on a different aspect: regulatory submission and assessment. Scarlet prescribes a specific submission format that customers must use to provide specific information about their business processes. Here’s why this is beneficial:
Clarity: It clearly defines what information is required for regulatory submissions.
Consistency: The format ensures the information provided is complete and consistent.
Efficiency: Scarlet’s experts can perform swift and thorough assessments thanks to the standardised format.
How does Scarlet fit into with QMS?
While companies developing SaMD might use various software tools to operate their QMS, Scarlet serves a distinct purpose. It does not directly help in operating the QMS but rather supports the regulatory submission process. This distinction is crucial when considering software validation.
The information that you submit to Scarlet about your QMS should be accurate at the time at which it is submitted. After submission, you do not need to constantly keep Scarlet updated with the same information as is in your eQMS, though it may be necessary to update the information provided to Scarlet before an audit.
Software validation requirements
Scarlet’s software does not require validation in the context of ISO 13485 since it doesn’t operate parts of a QMS.