In software validation, cloud-based software has all those advantages with the added bonus of greatly easing the validation process, including leveraging validation commonality (based on every customer's use of the latest software version on shared, secure infrastructure). In other words, since multi-tenant software shares some of the underlying infrastructure, the software vendor can leverage commonality across all customers to speed the time to validate.

For companies using document-centric or legacy QMS software, validation tends to be such a huge hurdle that companies often avoid implementing software upgrades. Improvements to product quality, delivery, and/or training are forgone in favor of the status quo. The process to validate these upgrades is so difficult and time consuming that many companies stay with the current version of software.

Cloud-Based QMS in Action

Here is an example of how a cloud-based QMS works for device manufacturers.

IntraOp Medical Corporation is a pioneer in portable electron-beam intraoperative radiation therapy. The IntraOp Mobetron has transformed cancer treatment by bringing radiation technology into the operating room, uniting radiation oncology and surgery. For patients and their families, this means markedly shorter treatment and recovery times, improved outcomes, and greater comfort and quality of life. This helps ensure that teams execute on product realization at the highest levels of quality and adhere to regulations.

As an FDA-regulated company, IntraOp not only designs and produces complex products with electro, mechanical, and software components, it does so while meeting all FDA 21 CFR 820, EU Medical Device Directive (MDD), ISO 13485, Health Canada, and other regulations. The IntraOp team needed more than a system to manage all the product details, changes to product, and collaboration efforts with the teams. They also needed a QMS solution to ensure absolute regulatory compliance and chose Arena Solutions to manage both product and quality management.

Relying on Arena's QMS solution, IntraOp was able to leverage an integrated product and quality management system. An Nguyen, director of regulatory affairs and quality assurance, shared that “information from the Arena Quality module, such as CAPA and non-conformances visualized through the Arena Analytics dashboard, allowed us to monitor the up-to-date performance of our product process, see the areas and suppliers which have unfavorable quality trends, and plan for our improvements or preventive actions.”

In the end, IntraOp gained immediate benefits with immediate visibility and access by their teams and dashboards that provide up-to-date performance. Nguyen further noted that “monitoring and measuring product and process performance are key requirements of medical device regulations.”

Summary

Medical device manufacturers must contend with more product, supplier, and team complexity than ever. Getting quality products to market fast is not sufficient. Companies must be able to navigate regulatory compliance and validation to meet FDA, ISO, and other regulatory mandates.

Cloud solutions, and more specifically, product-centric QMS solutions, provide maximum control, visibility, and traceability throughout the entire product life cycle. The ability to automate the review of designs, address quality issues quickly, and validate systems work as designed is simplified with cloud-based QMS solutions.

So, device manufacturers do not need to choose between great QMS capabilities or the ability to meet regulatory compliance and validation requirements. Rather, the cloud can ensure that the company develops safe and effective devices.

References

  1. Quality System (QS) Regulation/Medical Device Good Manufacturing Practices”.
  2. ISO 13485:2016, “Medical devices — Quality management systems — Requirements for regulatory purposes”.

  3. General Principles of Software Validation: Final Guidance for Industry and FDA Staff”.

This article was written by Ann McGuire, Product Marketing Manager at Arena Solutions, Foster City, CA. For more information, visit here.