Computer system validation (CSV) is a bit like going to the dentist — you know you need to do it and it’ll just get worse the longer you put it off, but it’s still painful. You can remove some of that pain by following guidance from the U.S. Food and Drug Administration (FDA) and GAMP 5 to make it faster and easier to validate. These best practices are based on our experience making software validation easier for our customers, but can they be used in any setting.
The FDA knows how much time and resources most companies spend on validating their software. That’s why the agency has emphasized using the least burdensome approach. Part of that includes leveraging a vendor’s internal validation documentation. This FDA-compliant software validation method means you get to use templates and documentation from the people who know the software the best — the vendor.
The FDA’s hardly the only one encouraging use of vendor efforts. GAMP 5 validation practices specifically state, “Where the system has been appropriately tested [by the supplier], there is no value in the regulated organization repeating those tests.”(1) Writing functional test scripts requires an in-depth knowledge of the software that is hard to achieve as a customer and makes the validation process take longer without adding value.
Your software provider is concerned with making sure their software works. However, they do have a specific way of using the software in mind when they perform their own software validation. That’s why leveraging the vendor’s documentation and testing is easier when you follow their best practices. Configurable software is great because it gives you adaptability, but the further from the best practice configuration you get, the more testing you’ll have to run to ensure compliant validation.
Testing how you use the software in your company is more important that testing functionality in isolation. This is one of the traps that companies can fall into when validating. Testing functionality that you don’t even plan to use is a waste of time. In the “Pharmaceutical cGMPs for the 21st Century – A Risk-Based Approach Final Report,” FDA software validation focuses on intended use as opposed to making sure everything works individually.
FDA software validation focuses on the risk to patients and product quality. However, your company’s critical business processes (CBPs) are also an important part of how you use the software. Deciding which CBPs to validate can be a difficult decision without the proper experience. The patented MasterControl Validation Excellence Tool (VxT) was developed to help customers with this and other problems and to help them use a risk-based approach to validation.
The FDA encourages a risk-based approach because it satisfies the reason behind validation without smothering the company in validation activities. Validation takes months when every aspect of the software is being tested as if it’s high risk. Taking just a little extra time upfront to do a risk assessment greatly reduces validation overhead. In fact, it can mean performing FDA compliant software validation on new software in as little as 20 hours.
The real time-savings with risk-based validation come with upgrades. Creating a full validation plan every time your vendor releases a new software version is a waste of time. GAMP 5 validation encourages change management as a way to implement faster by looking at the risk and complexity of the change. Only changes to the software should even be considered for testing and even then, only those that are high risk. This approach can reduce the time needed to validate an upgrade to as little as 45 minutes and eliminates the need for validation services from the vendor.
When every upgrade requires a grand total of 45 minutes to validate, quarterly upgrades become doable. Upgrading frequently actually reduces the validation burden over time. Postponing an upgrade leads to a full revalidation because by the time you decide to upgrade, the software has dramatically changed. Small changes that happen more frequently are a sustainable and compliant way to maintain your validated state.
These eight tips can reduce software validation time to a matter of hours or minutes. We’ve just briefly touched on each tip here, but more information is available in our industry brief, “8 Tips for Compliant and Quick Software Validation.”
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