3 methods to simplify QMS software validation

Regulatory bodies like the FDA require you to validate any software that has an impact on your GxP operations. Unfortunately, traditional software validation is famously complicated, time-intensive, and a burden on Quality teams.

But it doesn’t have to be.

Before you sign up for that IT crash course, take a look at these three ways to take the stress out of your QMS and simplify software validation. 

1. Take a risk-based approach to software validation

Originally, Computer System Validation (CSV) was the go-to guidance for how to conduct software validation. However, this guidance quickly led to over-documentation and overly complicated validation processes – and the FDA realized it.

Thankfully, they replaced CSV with new guidance called Computer Software Assurance (CSA) in an effort to simplify the process without sacrificing compliance.

What's the main difference between CSV and CSA? CSA encourages taking a risk-based approach to software validation.

A risk-based approach means focusing your validation strategy on the software features that:

• You actually intend to use
• Have an impact on your GxP activities
• Pose a potential risk to product quality, patient safety, data security, etc. 

For example, let’s say you’re using an eQMS for document control, training management, and quality issues/change controls.

With the traditional CSV approach, you’d likely validate every module and feature regardless of its impact or your usage. That takes a lot of time.

But with a risk-based validation approach, you might focus on thoroughly validating the Training module, the Document module, CAPA workflows, and user access controls. You don’t plan to use the Audits module, so you decide not to extensively validate vendor management features. You also decide user notification preferences have no impact on your GxP activities or product quality and therefore choose not to focus validation on this feature.

In the future, if you decide you do want to use vendor management features, you simply revalidate the software and include that functionality in your tests. (See tip #4 for more info on revalidation). 

The Complete QMS Software Validation Guide

Learn how to conduct validation using CSA guidance, plus get a revalidation checklist in this complete guide for Quality Management professionals.

2. Leverage vendor validation documentation

Another benefit of the CSA guidance from the FDA? It encourages organizations to leverage the validation documentation of their vendors to help simplify the software validation process.

This is helpful because it means you don’t have to start validation from scratch. The vendor has already tested and verified core system functionality, verified compliance with regulations like 21 CFR Part 11 or Annex 11, and documented test protocols and results. It’s then up to your own quality team to validate the system based on your intended use (like verifying that categories, workflows, user groups etc. are all set based on your specifications).

Because the vendor has already validated their system and provided you with that documentation, it reduces your validation scope. That means less stress and faster implementation.

But there are a couple of things to note here. 

Make sure your eQMS is pre-validated.

This all relies on the assumption that you choose a pre-validated eQMS platform. Pre-validated meaning that the vendor has already performed and documented their validation activities for the system’s core functionality.

“Configurable” is better than “customizable”.

A configurable eQMS means users can change settings, categories, workflow stages, signature requirements, user roles, and more using built-in tools without changing any code. Think of it as built-in flexibility.

A customizable eQMS means that any changes to the system’s standard templates require coding and IT support. Some platforms may offer customization, but they’ll charge you for it. Think of “customizable” as tailored, but complex.

When it comes to validation, a configurable eQMS is easier to navigate than a customized one because you can still utilize the vendor’s validation documentation. With customization comes complexity, and your unique, customized version of the system will require more rigorous validation.

Learn more about the difference between a customizable and a configurable eQMS here. 

Watch out for validation fees

Second, not all QMS software vendors will provide their validation documentation free of charge. When this happens, Quality teams are left to decide whether to shoulder the full burden of validation or fork up more money on top of implementation. The kicker is that you might be hit with that validation fee all over again any time you need to revalidate the system, like after a major software update.

At ZenQMS, we think validation should be a standard part of implementation, so we don’t charge for access to our validation documentation, even when it’s time to revalidate. We also provide a User Acceptance Testing (UAT) template at no extra cost.

Long story short, talk to your vendor about validation and make sure you understand any costs associated with validation and validation support.

3. Understand when to requalify your software and when to revalidate

Software platforms release new versions fairly frequently. Sometimes those releases are just a few simple bug fixes and sometimes they’re major updates to the system. Depending on the size and impact, you may need to revalidate your QMS software platform.

The key is knowing when to revalidate your eQMS and when it’s acceptable to simply requalify the platform.

Revalidation involves running test scripts again to prove your configurations, roles, system settings, etc. still work the way you need them to. On the other hand, requalification is confirming the QMS software is still fit for its intended purpose after an update. That could mean you simply read the release notes and decide there’s no major impact to your use of the system. 

Requalification is a much simpler process than revalidation, so knowing when it’s acceptable will ultimately save your Quality team a lot of time. There’s more that goes into the process, so check out our full QMS software revalidation guide here.

If you’re curious to learn more ways the right QMS software can simplify your quality management, check out this 3-minute demo of ZenQMS.