What is an Electronic Quality Management System (eQMS)?

Electronic Quality Management System Definition

An electronic quality management system (eQMS) or enterprise quality management system is software that documents and manages business processes for product development, quality, and compliance across the entire organization. It is typically designed with a cloud-based IT infrastructure and data model which facilitates cross-functional communication and collaboration.

What is a Electronic Quality Management System


Why do you need an 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.

Why is QMS software important?

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
What are the different types of quality management systems?

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:

What is QMS and its purpose?

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.


To maintain a competitive advantage in today’s global market, life sciences companies are tasked with maximizing productivity, while meeting customer expectations and regulatory requirements. To meet these goals, many organizations rely on enterprise quality management system (QMS) software solutions to get high-quality products to market fast.

Learn everything you need to know about QMS software and key factors that you should consider when exploring compliant quality management processes.