Electronic Quality Management Systems (eQMSs) are emerging as revolutionary technologies that alter the traditional paradigms of quality control in the fast-paced world of modern business, where quality management is crucial. eQMSs offer streamlined solutions for document control, corrective action, audit management, and more-aspects that are at the forefront of efforts made by any organization to achieve operational excellence and compliance in the digital age.
Quality management systems have historically been established using paper-based techniques. However, these approaches are frequently ineffective and prone to mistakes. By automating quality management procedures, an eQMS system helps organizations overcome these obstacles by facilitating the tracking and management of data, documents, and workflows. The goal is simple: to automate quality management processes that businesses use to guarantee compliance and enhance product quality while cutting expenses and time to market.
In this blog, we will provide a brief overview of electronic quality management systems (eQMSs), highlighting their importance, how they differ from paper-based QMSs, and how they generally function.
What is an Electronic Quality Management System (eQMS)?
An Electronic Quality Management System, or eQMS, helps companies streamline and automate their quality control procedures. Quality teams may effectively and centrally manage and monitor various quality management-related tasks using eQMS, including supplier management, training management, document control, change management, and many more.
An electronic quality management system’s main objective is to guarantee that a company complies with legal and industry standards while consistently raising the caliber of its output. The electronic quality management system (eQMS) facilitates proactive problem identification and resolution for businesses by allowing them to monitor adherence to industry standards and regulations. It is usually set up on a cloud-based platform that all authorized users can access anytime from any location.
Why is an Electronic Quality Management System (eQMS) Important?
Electronic quality management systems give organizations a regulated and automated means to manage product and quality processes across the whole lifetime, in contrast to paper-based systems that are difficult to maintain and keep up to date.
They also provide revision control functionality and improved control over protocols, processes, and test documents. Ensuring electronic documentation of requirements, protocols, test case outcomes, and sign-off events across the verification and validation stages facilitates more efficient processes, improving the audit experience.
QMS software helps businesses address these key new product development and launch challenges:
- Working together with remote teams, vendors, and contract manufacturers;
- Restricting access to interconnected systems harboring product and quality data;
- Creating efficient design controls to abide by quality system requirements; and,
- Simplifying audit procedures and launching superior products in less time.
In the following section, we will delve into the challenges posed by paper-based quality management systems and how an eQMS resolves them.
How Do eQMSs Differ From Paper-Based Quality Management Systems?
Quality management systems are majorly required by medical device manufacturers. While some may successfully implement paper-based QMSs, electronic QMSs have been trending for more than five years. Let’s understand why.
- Lost Documentation: There are usually insufficient checks and balances in a paper-based filing system to guarantee that the system is always up to date with the most recent versions of the documents. The manufacturer might not be aware of the loss or misplacing of a document when it is taken out of the filing for review or modification until an FDA auditor requests to see the document. Medical device makers can now have much better oversight over the availability and completeness of QMS documentation thanks to an electronic QMS, eliminating misplaced paperwork.
- Lack of Document Controls: Medical device manufacturers are required by the FDA quality system standards to create and maintain document controls that meet 21 CFR Part 820 requirements. Document controls incorporate extra criteria to guarantee that the most recent documents are available anywhere they are designated, used, or otherwise required, in addition to the necessity for approval signatures on all documents created in accordance with the quality system principles. Using an electronic QMS that facilitates document version management contributes to the guarantee that the most recent authorized documents are constantly accessible for reference or audit purposes.
- Missing Signatures: Documents included in the QMS must go through a stringent approval process mandated by the FDA. Medical device manufacturers must choose a representative, usually the quality manager, to examine and approve a range of papers in the quality management system. The quality manager must also give their permission again for revisions to documents. Using automated tools and electronic signatures, an eQMS streamlines the process and helps medical device businesses track when and where approvals and signatures are needed.
How Does an Electronic Quality Management System (eQMS) Work?
An electronic quality management system (eQMS) first connects an organization’s quality-related procedures and data into a single system.
It offers a single location for all data and documents, simplifying the management of workflows and business processes and helping you achieve quality and compliance goals.
Some of the main characteristics of a digital QMS are controlling document workflows, supporting QMS processes, facilitating electronic signatures, sending automatic alerts and reminders, and enabling real-time task progress visibility.
Here are some of the main functions a good eQMS must perform:
- Document creation, editing, reviewing, approval, and archiving;
- Facilitate electronic signatures for the digital signing of papers;
- Manage access to documents according to pre-determined user roles and permissions;
- Monitor and handle quality incidents, including CAPAs, audit findings, customer complaints, and non-conformances;
- Supplier management, equipment calibration, risk management, employee training, change control, and design control, among other QMS procedures;
- Report creation and evaluation of high-quality data to spot patterns and areas needing ongoing development;
- Arrange, coordinate, execute, and maintain records for quality audits; and,
- Provide assistance in ensuring adherence to quality standards.
An effective electronic quality management system (eQMS) should be compatible with your company’s processes and adaptable enough to change with your needs.
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