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 organizations 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 organizations 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 organizations 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 standardized format.
What software do companies use to support a QMS for SaMD?
Companies developing Software as a Medical Device (SaMD) commonly use a combination of software tools to support their QMS. These tools may include:
Software Development Lifecycle: Jira, Confluence, CircleCI, GitHub
Human Resource Information Systems (HRIS): HiBob, Rippling
Clinical and Risk Management: Airtable, Google Sheets, PaperPile
Customer Support: Zendesk, Zoho, Intercom
These tools help manage various aspects of the business, from software development to customer support, ensuring that all processes contribute to maintaining high-quality standards.
What software does Scarlet provide?
Scarlet provides two key software applications:
The Scarlet VSCode Extension
The Scarlet Command Line Interface (CLI)
These tools are specifically designed to:
Enable the submission of regulatory data for conformity assessment.
Review the outcomes of conformity assessments performed by Scarlet.
How do GitHub and VSCode integrate with Scarlet?
GitHub and VSCode, both owned and maintained by Microsoft, are industry-standard tools for software development and change control. Scarlet utilizes these tools in its submission process:
VSCode: Used to create conformers, documents or data sets prepared for submission.
GitHub: Serves as the platform for submitting and assessing regulatory data. It also helps fulfill document control requirements, as specified by standards like ISO 13485.
How does Scarlet fit into your 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.
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. However, any software used to help operate a QMS must be validated according to ISO 13485 standards:
ISO 13485 Clause 4.1.6: The organization shall document procedures for validating the application of computer software used in the quality management system. Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application.
This means that eQMS systems like Formwork or Matrix Requirements and other tools like Jira or GitHub must be validated to ensure they function correctly and meet regulatory requirements.
Document and record control with GitHub
Scarlet allows customers to use GitHub to meet document and record control requirements under ISO 13485. This involves:
Code Ownership Configuration: Ensuring only authorized personnel can make changes.
Branch Protection Rules and Pull Requests: Used to control changes to the main branch, ensuring that all modifications are reviewed and approved before implementation.