GxP compliance checklist: What you need to know

Companies across all verticals face rising pressure to produce high-quality software at breakneck speeds. But for companies in regulated industries like pharmaceuticals and healthcare, creating software is even more challenging because regulated businesses must adhere to Good x Practices (GxP) standards throughout the development process.


If you’re looking for background information on GxP, you’re in the right place. Read on to learn what it means to be GxP compliant, along with an overview of why it’s important and a compliance checklist to streamline the process.

What is GxP compliance?

GxP is a broad term that applies to many different quality standards and regulations. Viewed through a software development lens, GxP compliance means that a system meets a specific set of regulatory protocols and best practices.

There isn’t a central governing body that oversees GxP compliance within software development. Instead, companies must adhere to specific standards set by regulatory bodies, which can vary across different regions and industries.

Some examples of these regulatory bodies include:

  • U.S. Food and Drug Administration (FDA)
  • Federal Communications Commission (FCC)
  • International Organization for Standardization (ISO)
  • European Union Medical Device Regulation (EU MDR)
  • European Medicines Agency (EMA)

When a product is GxP compliant, it means the solution aligns with the various requirements set forth by specific regulatory agencies. For example, the FDA’s 21 CFR Part 11 compliance states that companies must treat electronic records and signatures the same as paper records and handwritten signatures.

Why is GxP compliance important?

Government bodies and agencies routinely monitor and enforce GxP compliance through audits, inspections, and certification requirements. As a result, digital organizations in regulated industries must do their due diligence to understand all of the various regulatory requirements before bringing a product to market.

Failure to comply with GxP regulations can lead to a variety of negative consequences, such as fines, penalties, and sanctions. In addition, failure to comply can potentially lead to poor data integrity, privacy and security issues, and business disruptions.

What is a GxP assessment?

Before proceeding with software testing, it’s necessary to conduct an initial GxP risk assessment. The point of a GxP assessment is to analyze the software’s potential impact on patient safety, data integrity, or product quality. The initial GxP assessment also helps form a testing strategy.

What does GxP cover?

Since no single agency oversees GxP compliance, software assessments tend to vary in terms of their scope and individual requirements. However, the process typically involves analyzing the software development lifecycle from end to end.

With this in mind, we’ve listed some of the core requirements for achieving GxP compliance in your software.

Software must have thorough documentation covering the entire production process, including development, configuration, testing, maintenance, and decommissioning.

Data integrity and protection
A critical part of GxP compliance involves demonstrating data integrity, reliability, and protection across all stages of development and deployment. Keep in mind that GxP data requirements can vary across different regions.

Companies should have training programs in place to guide end users and instruct them about key software functionalities and potential compliance issues. It’s necessary to document training policies using standard operating procedures and update them with each release.

Software must also go through a comprehensive validation process to ensure that the program works properly and is capable of delivering its intended outcomes. Validation should span across multiple levels, including functionality, user interface, and data integrity.

Change management
Businesses must have a change management policy in place to document all updates and releases. A key part of change management involves documenting all ongoing testing, updates, and evaluations.

Streamline GxP compliance with Tricentis

Businesses in regulated industries have little choice but to produce GxP-compliant software. However, this can be a tremendous burden due to evolving standards, staffing shortages, and aggressive development timelines.

Tricentis Vera™ expedites compliance management by offering a single, unified interface for reviewing and approving all development processes. By using Vera, your business can expedite software validation and ensure FDA compliance. Vera generates auditable electronic records and provides pre- and post-execution approvals for automated tests. The software also integrates with Tricentis qTest and Jira, enabling agile planning and continuous testing workflows in regulated and non-regulated environments.

To experience Vera in action, request a demo.