Efficient and Cost-Effective Computer System Validation – Here’s How

Validating computer systems (software, equipment, or IT Infrastructure) is necessary in pharmaceutical facilities to ensure compliance and protect patient safety. The challenge is that traditional computer system validation (CSV) methods are resource-intensive, time-consuming, and costly.

They are also prone to human error, process-focused (rather than patient safety-focused), and rigid.

Computer software assurance (CSA) and GAMP-5 risk-based principles, combined with best-in-class technologies, offer an alternative approach that ensures compliance but does so in a fraction of the time and with considerably lower costs.

In this blog, we will explain how to make CSV both efficient and cost-effective.

The Problem with Traditional CSV

To develop a solution, it is important to first understand the problem. So, what’s wrong with traditional CSV processes?

There are several, but for this blog, we are going to focus on the three main issues:

• One-size fits all
• Duplication of effort
• Manual processes

A more detailed explanation for each is below, but they all add up to a process that is inefficient and more costly than it should be.

One-Size Fits All

Using a traditional CSV approach, everything that comes under the definition of a computerized system is treated the same. So, for example, the process to validate an off-the-shelf software application that poses minimal risk to patient safety is treated the same as a fully bespoke software application that is a potential high-risk to patient safety if it doesn’t perform as intended.

That is not a good use of time, money, or resources, and it detracts from the main objective of CSV – to ensure pharmaceutical products are safe for patients.

Duplication of Effort

There is a lot of repetition and duplication of effort in a traditional approach to CSV. For example, a pharmaceutical company that creates documentation for a software application that already exists from the software’s vendor. This type of duplication doesn’t add any real value as it doesn’t contribute to patient safety. It is repetition that inflates costs without improving outcomes.

Manual Processes

Validation processes are commonly manual and often paper-based. This takes time and increases the risk of error during CSV, as well as making audit preparations more time-consuming and resource-intensive than necessary.

How to Make CSV More Efficient and Cost-Effective

Adopting a Risk-Based Approach

The first step in making CSV processes more efficient and cost-effective is to adopt the risk-based principles of CSA and GAMP-5. In other words, rather than treating all computerized systems the same, your approach should differ based on patient-safety risk profiles.

This requires applying another important principle in CSA and GAMP-5 – critical thinking. Critical thinking involves defining critical functions, performing risk assessments, and then tailoring testing according to risk.

With this approach, low-risk applications may require minimal testing, while high-risk systems undergo rigorous validation (see the image below).

Throughout the process, risk assessments and decisions should be documented for audit purposes and to help make future validation tasks more efficient.

Minimize Documentation

Creating documentation is one of the most costly and time-consuming tasks in traditional CSV. However, adopting a risk-based approach that utilizes critical thinking ensures you only document what is essential.

Key to this is eliminating duplication, especially the duplication of vendor-created documentation.

During an Empower application validation project at one of our client sites, we utilized vendor-provided IQ (Installation Qualification) and OQ (Operation Qualification) documentation. This accelerated the process, delivering substantial time savings and reducing overall costs.

Strategic Planning

Good planning will also help cut validation timelines and costs.

The starting point is to choose the right validation partner. At Westbourne, for example, we have a strong track record in the delivery of validation services with predictable, transparent pricing and no hidden fees.

It’s also beneficial to use digital, automated validation platforms and templates that eliminate time-consuming manual processes while making compliance and audit preparation significantly more streamlined.

Choosing the right software vendors is also important, whatever type of laboratory, production, or IT application you are purchasing or commissioning. Working with a reliable vendor means you can trust the quality of their documentation and testing results, ensuring compliance with reduced costs and effort.

The final point to make on strategic planning is to start the process of validation as early as possible. Ideally, validation processes (such as conducting risk assessments and documenting the results) should be factored into your project from the beginning.

Other Considerations

Focusing specifically on optimizing the cost and efficiency of validation, there are some other considerations to highlight:

• Validation is an ongoing process that should cover the full lifecycle of computerized systems. This includes commissioning, change control (updates, upgrades, relocations, and other significant changes to how you use software applications and IT), and decommissioning (for migration, archival, and/or destruction). Adopting a lifecycle approach from the start helps to keep costs down in the long term.
• Managing change is crucially important, especially if operational and leadership teams are familiar with traditional CSV. Established processes are time-consuming and costly, but they are also trusted, familiar, and effective. As a result, a robust change management process is necessary that includes creating new SOPs, providing training, and involving all stakeholders to ensure cross-functional collaboration and process alignment.
• Embracing new technologies can also help make CSV more efficient and cost-effective. AI technologies are an example. There remains a lot of work to go through before AI technologies can be introduced into regulated pharmaceutical environments at scale, but they are likely to play a role in the future.

Efficient and Cost-Effective Computer System Validation – A Summary

Reducing the cost of validation and making the CSV process more efficient involves taking a risk-based approach according to CSA principles. This includes utilizing critical thinking and tailoring testing and documentation according to risk. Minimizing documentation by leveraging information from vendors is also important.

And you need support from experienced consultants – consultants with validation, scientific, and IT expertise. This unique group of skillsets is our area of specialty at Westbourne. To discuss your validation requirements, please get in touch.

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