Software Validation in the Cloud: How Medical Manufacturers can Meet Requirements

Cloud software like an ERP system can transform businesses by offering valued features like automation, mobile access, scalability, and real-time insights. Medical device, equipment, and supplies manufacturers frequently want the advantages of a cloud setup, but they often hold back because of one reason: software validation. 

Medical manufacturers must maintain software system validation. It’s non-negotiable for the FDA, meaning that if you are found to be negligent, you will be in major trouble. With so much on the line, many manufacturers shy away from joining the cloud because they are afraid of messing up software validation.

But before giving up on the cloud entirely, we recommend exploring your options. It is possible for medical manufacturers to maintain software validation standards while gaining a sophisticated software tool like a cloud ERP. With Infor’s CloudSuite Industrial (CSI), for instance, you can enter the cloud without compromising software validation. Here’s how CSI allows medical manufacturers to finally access the cloud.

What is Software Validation?

For the FDA, software validation is when there is demonstratable, documented evidence that a company’s software accurately and consistently produces results that meet compliance and quality management requirements.

To put it even more simply: is your software meeting compliance and quality management standards? Do you document and prove it? If so, then you are meeting software validation.

FDA Software Validation Requirements

There can be a lot of pieces, but the FDA actually leaves the specific strategy for meeting software validation up to manufacturers. In fact, there are only a few absolute requirements that the FDA gives for software validation:

• You must meet FDA standards for production and inventory management, specifically for your products and business processes
• You must document every step and aspect of validation

How the Cloud Impacts Software Validation

Even though software validation may sound simple when broken into its two core requirements, it can easily get out of hand. Using cloud software can complicate software validation, particularly with the wrong ERP. To maintain regulatory compliance as outlined in 21 CFR Part 11 and 21 CFR Part 820, you will need to ensure data integrity and preventive controls. This means looking for an ERP that has a “closed” cloud data architecture, features like change control for data, and configuration options to support significant processes.

CSI Lets Medical Manufacturers Gain Cloud ERP

CloudSuite Industrial (CSI) from Infor gives medical manufacturers the functionality they need to configure the ideal ERP setup for software validation. Even as a cloud ERP, CSI has the necessary propriety protocols needed for software validation. As a one-stop shop for ERP, Datix is the best ERP partner for implementing CSI. We will set up your system with software validation in mind so it is a seamless part of your business processes.

For instance, let’s consider electronic signatures (e-signatures). E-signatures are convenient because no one needs to worry about paper records, but they can be found invalid if set up incorrectly. With CSI, you can configure your software to require that e-signatures are received and recorded every time. Much of the e-signature process can even be automated, making it fast, easy and convenient even while you demonstrate software validation (for more information on configuring e-signatures to align with 21 CFR Part 11, read our free e-book on multi-level supply chain management).

Instead of being scared of the cloud, CloudSuite Industrial can let your organization gain all the advantages of an interconnected system. To learn more, talk to the team at Datix. With our business-first approach, we learn what your software needs are so that we can give you the ideal ERP solution for your business.

Wrap Up

Software validation can be intimidating, but it doesn’t need to stop your company from entering the cloud. With a trusted partner like Datix, your organization can successfully implement a CSI cloud ERP and unlock even more potential at your organization.

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About Datix

For medical manufacturers, Datix is the ERP consultant of choice. We recognize that each manufacturer is unique and requires a tailored solution to meet their business goals. Our team will partner with you every step of the way to bring your organization to the next level.

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