What is an Electronic Quality Management System (eQMS)?

Unlike paper-based systems which are difficult to maintain and keep up to date, electronic quality management systems provide organizations a controlled and automated way to manage product and quality processes throughout the entire lifecycle. Using electronic change management software means revision control functionality and better control over protocols, procedures, and test documentation. Documenting requirements, protocols, test case results and sign-off events during the verification and validation phases electronically also allows for smoother processes and ultimately a smoother audit experience.

QMS software helps companies address these key new product development and introduction (NPDI) challenges:

• Collaborating with dispersed teams, suppliers, and contract manufacturers
• Disconnected systems limiting visibility into quality and product information
• Developing effective design controls to comply with quality system regulations
• Streamlining and simplifying audit processes
• Delivering high-quality products ahead of the competition

There are many different types of quality management systems available to manufacturers looking to improve results, track their progress, and enhance quality. The type of QMS varies based on the industry and specific goals of your business. The ISO family of international quality standards is considered to be the most widely adopted approach to quality management systems. Many organizations use ISO 9001 as the basis to develop their own QMS program. Other ISO standards related to QMS include:

• ISO 13485: (QMS for medical devices)
• ISO 14971 (Risk management for medical devices)
• ISO 9004 (Continuous improvement/guidance to achieving sustained success)

A quality management system provides a formalized system of documenting responsibilities, processes, and procedures to develop products that meet customer requirements as well as compliance with regulatory standards. It should align with an organization’s goals and provide a systematic approach to help improve quality controls, eliminate nonconformance issues, reduce audit risks, and streamline new product development processes.