Understanding Regulatory Requirements for Software Validation in Life Sciences

Software Validation in Life Sciences

In the life sciences, every company that produces regulated products must validate the software that they use. This is a critical process that helps ensure quality.

Historically, this has been managed as a paper-based process. Implementing a robust EQMS allows the process to be automated and streamlined to deliver substantial time savings without compromising quality.

Regulatory Requirements

As part of a Quality Management System, Life Sciences businesses must validate their software to ensure their systems meet FDA standards and regulations. The validation process involves a third-party verification firm configuring the software to comply with GxP requirements (GLP, GMP, GDP) and testing it to confirm that it works how it is supposed to, just like an accountant verifies financial records. This is a necessary step before the company can begin producing regulated products using the system, and it must be repeated every time there is a change in the software or hardware.

This is one of the many reasons that life science companies should work with a partner who can deliver a turnkey QMS solution with validation-as-a-service capabilities to help minimize the cost and complexity of software validation. With this approach, a single set of automated scripts runs against the entire application portfolio to provide IQ, OQ, and PQ system tests at the push of a button, eliminating the need for life sciences companies to perform expensive, manual re-testing after every software upgrade.

In addition, a continuous validation approach provides life science companies the peace of mind that their software is always compliant. This is because, as opposed to a traditional validation model that requires the regulated business to manually validate their software, the underlying infrastructure of cloud-based apps stays continuously validated and can be automatically updated whenever there are updates to the application code.

Documentation Requirements

A life science business needs to demonstrate its software is fit for its intended use. This involves examining the software to confirm it satisfies specific requirements and is consistently fulfilled. This examination may include stress testing multiple data sets, performance testing across various browsers and devices, and more. It also includes reviewing the software with end-users to ensure it meets their functional needs and any regulatory considerations.

Software like the life sciences compliance software that creates, modifies, maintains, archives, retrieves, or transmits FDA-regulated records must be validated for the record. This includes software used in Quality Management programs, software for medical device production and control systems, and software that is part of the processes used to prepare for or submit to FDA approvals.

Life science companies are often compelled to make tradeoffs that limit their ability to leverage the full potential of new software. These trade-offs can include delaying software upgrades for years or avoiding customizations requiring initial validation and subsequent revalidation upon promotion.

This is especially true for businesses that rely on vendors to provide or sell functional specifications and OQ tests. A regulated company should always supplement vendor documentation and perform its own PQ tests to ensure the functionality it needs is covered. In general, minor software updates that do not alter the functionality of a system will not require re-validation.

Functional Requirements

Software validation is an essential part of any life sciences business. It helps ensure that the company’s production processes, inventory management, and other operational activities meet the requirements of the FDA and GxP (good manufacturing practices).

The first step in any validation project is establishing the software’s functional requirements. This includes the infrastructure needed to support the system (such as hardware, servers, and network connections), software features, and user interfaces. During this phase, a risk analysis should also be conducted to discover any gaps in functionality.

Once the functional requirements are established, the business should work with a third-party validation firm to prove that the software meets these standards. This involves a comprehensive testing and confirmation process, like auditors verifying accounting records.

When validating a piece of software, it is essential to test only those features that will be used. This can reduce costs and save time during the validation process. For example, if a software feature is not used, it can be turned off or configured so that users cannot access it. This will ensure that only the required components are tested and validated, ultimately saving the business time and money. This approach, known as test-driven validation, or TDV, is a highly efficient way to meet software validation requirements.

Security Requirements

While validation is inherently time-consuming, it doesn’t have to be a bottleneck to life sciences business productivity. With some planning, it’s possible to validate software and systems faster than ever while keeping the FDA-required quality standards intact.

A key piece of this strategy involves using a risk-based approach to validation. The FDA has long recommended this method because it satisfies the reason behind assurance without smothering businesses in bureaucratic red tape. A risk-based approach lets a company decide what steps are necessary and how to perform them, then document the results.

The first step is to determine the scope of the project. Then, a business can determine the risk of each step. For example, a lower-risk project may only need IQ, OQ, and PQ, while higher-risk projects require additional steps like SIT, UAT, and performance testing.

Another way to reduce validation time is to leverage the documentation provided by your software vendor. For instance, the USDM Life Sciences team has extensive experience with the most common life science software vendors. It can help you create user requirements, confirm standard functionality (OQ), and test how your company will use the product (PQ).

It’s essential to consider validation support when choosing a software vendor. The right vendor will help you stay compliant for years, so don’t settle for a solution that only provides validation support during the initial implementation.