The Quality Management System (QMS) is one of the key elements of any Medical Device or Life Sciences Manufacturing Organization. It is a solid framework of business processes and practices that ensure the safety of patients and the satisfaction of customers.

Having said that, the execution and maintenance of the system components (Quality Manual, Standard Operating Procedures, Work Instructions, Forms, and all related documented evidence) can be a monumental task that requires a significant amount of resources.

To implement and maintain an effective QMS can be a daunting proposition, especially when you are a startup. At ITEK, we realized early on that the traditional paper-based approach to develop and operate the Quality System was not going to be an option.

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HOW WE DID IT

As part of ITEK founding principles, we had already decided to only use cloud or web-based technologies. This was meant to simplify management of the IT infrastructure and create a more user-friendly and consistent working environment. We didn't know a cloud-based eQMS existed, but we decided to find it!

A few of the system requirements we set were: 100% cloud-based with no custom server or client component, capable of running purely on a web browser under Desktop, Mobile and Tablets running any Operating System, completely paperless and capable of electronic signatures in compliance with 21 CFR Part 11 (Electronic Records; Electronic Signatures - Scope and Application).

It was definitely a tall order, but a small startup called ComplianceQuest had already released a solution that met all those requirements! After a quick demo, we knew we had found a match made in heaven. We signed the contract and have never looked back.

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BENEFITS

Here are some of the key benefits we have discovered during this journey:

• The workflow in the system eliminates the need for many forms: In a paper-based system you need forms for initiation and management of a document change order, for instance, but in an eQMS, the actual workflow in the Change Order module replaces the form as the system documents and tracks the change order as it progresses through. The same applies to Non-Conformances, CAPAs, Equipment PM and Calibration, Employee Training, etc. etc.
• Less "paper-pushing" results in a reduction of QMS resources: An electronic paperless system allows us to get things done, having the system work for the organization, instead of the organization working for the system.
• Electronic records turn data into information: Every single piece of documented evidence is cataloged and searchable, it becomes a piece of information that can be quickly found, aggregated and charted. Management Review becomes a breeze!
• Controlled documents become ubiquitous with iron-clad revision control: Released versions and user-level security allow for clean delivery of documents to any user at the current revision level anywhere in the facility...and in the world!
• My personal favorite is universal access to tasks, pending approvals, training requirements: You can approve a Document Change Order from your phone while running to your airport gate! (Personal experience!)

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TAKE AWAY

In summary, choosing an eQMS system even before starting operations was one of the best business decisions we ever made. The benefits of the system clearly outweigh the costs during day-to-day activities, management reviews, and quality system audits. It has become a foundation stone for our company and an enabler to a continuous improvement organization.