QMS in Industry 4.0

by Govind Yatnalkar | Aug 5, 2020 | FDA, Medical Devices, Pharmaceuticals, Quality, Regulatory

medical device documents being uploaded to a QMS

Currently, we live in a world driven by the 4^th Industrial Revolution in which science and technology are continuously evolving. But what exactly is Industry 4.0? It is the process of using tech platforms like Cloud, IoT, AI, and Analytics to digitize conventional business methods¹. Specifically, in the medical device domain, tech platforms can be essential for housing and managing a QMS.

QMS stands for Quality Management System in which the safety and effectiveness of a product are ensured by complying with regulatory requirements and international standards. In the Industry 4.0, it is better known as the “eQMS” or the Enterprise (Electronic) Quality Management System. An eQMS is immensely useful as the process of managing documents and other QMS functions are automated. An eQMS provides a wide range of functionalities, from document creation and retention to the auto-trending of nonconforming product to CAPAs. But why is an eQMS beneficial over a conventional, paper based QMS? The following are just some examples of how an eQMS is more powerful than the conventional QMS²:

Encourage Automation: Automate 90% of tasks. Also, increase space for managing all clients in one single virtual web or mobile application.
Power Search: Find a document in seconds instead of investing hours in searching through several files or folders.
Create/ Modify/ Delete Once, Reflect Everywhere: When a document is created, modified, or deleted, the application reflects the status in all sections at the same time. The site synchronously reflects all updates, avoiding redundant updates using the database transaction model.
Option for Backup: If a document is modified with errors or deleted erroneously, there is always a backup copy ready.
Access Control: Through a web or mobile app, user access can be provided or invoked on a document. If an admin wishes to provide user access to specific users for a certain type of document, the e-QMS provides this functionality.
Keep Data Clean & Maintained: Obsolesced documents are automatically retained in an archive. This action facilitates maintenance and avoids the creation of conflicting data.
Document Management Including CAPAs: Track and manage all documents in one place through a Cloud or Server based interface service.

One of the biggest advantages of an eQMS is the search and notifications functions³. The time it takes to search for a specific document in a directory is reduced as optimized search algorithms provide multiple results within milliseconds. Additionally, an eQMS can provide notifications via auto-generated emails to all the users associated with the update. Indeed, for any medical device firm, an eQMS is a necessity.

Are you looking to transition from a paper based QMS to an eQMS for your firm? Our experts at EMMA International can help you implement a state-of-the-art eQMS system, seamlessly transitioning all parts of your current QMS to an eQMS. Contact us at 248-987-4497 or info@emmainternational.com for more information.

¹Kari Miller (February 2018). Smart Quality Management: The Impact of Industry 4.0 on QMS retrieved on 07/28/2020 from https://www.pilgrimquality.com/blog/smart-quality-management-impact-industry.

²Stendard (January 2020). EQMS – Benefits and Why I Need It retrieved on 07/28/2020 from https://www.stendard.io/blog/eqms-benefits-and-why-i-need-it.

³Filip Heitbrink (July 2018). Reasons Why You Should Turn Your Paper-based QMS into an e-QMS retrieved on 07/28/2020 from https://blog.qualitykick.cloud/8-reasons-why-you-should-turn-your-qms-into-an-eqms