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.
Since no single agency oversees GXP compliance, software assessments tend to vary in terms of their scope and individual requirements.
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.
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.
Checklist for achieving GxP compliance
Before proceeding with GxP planning, you’ll want to identify the specific regulatory frameworks that apply to your business and industry. Then employ the following best practices to achieve GxP compliance in your software.
Good Manufacturing Practices
Just as the name suggests, Good Manufacturing Practices (GMP) are a set of quality control mechanisms for manufacturing environments. However, you can apply some of these principles to software development as well.
- Define and adhere to a software development lifecycle (SDLC) process.
- Document all requirements, specifications, test protocols, and validation reports.
- Set up change control procedures to manage system modifications.
- Establish strong data integrity and security controls.
Good Software Engineering Practices
Following Good Software Engineering Practices (GSEP) will ensure that all software development and testing takes place in a controlled and compliant way.
- Create and stick to a clearly defined SDLC process.
- Collect and maintain comprehensive documentation for all specifications, designs, test plans, and manuals.
- Conduct thorough validation and verification tests.
- Perform version and change management across all stages of development.
Good Automated Manufacturing Practices
The Good Automated Manufacturing Practices (GAMP) guidelines are intended for developing and maintaining automated systems. These guidelines specifically apply to pharmaceutical and healthcare environments.
- Identify all potential risks that users may face with your software.
- Implement controls to manage and reduce risks.
- Set up a quality management system (QMS).
- Define the intended performance and regulatory requirements of the target system.
Good Clinical Practices
Good Clinical Practices (GCP) is a global set of quality standards governing clinical trials with human subjects. These standards primarily relate to ethical and scientific matters and ensure that trial participants receive safe and humane treatment. In addition, GCP standards ensure data validity and integrity.
- Implement data integrity controls to ensure accurate, complete, and reliable data.
- Set up data security measures like real-time data monitoring and alerts, encryption, and strong access controls.
- Document all changes and activities within your software, including configuration adjustments, validation reports, and system updates.
- Create standard operating procedures to define all processes and workflows.
Good Laboratory Practices
If your business is using software in a laboratory environment to collect or process data, then it must follow Good Laboratory Practices (GLPs), which are a set of quality standards for maintaining reliability and integrity in non-clinical laboratory studies.
- Implement measures to avoid data loss and manipulation. These may include audit trails and validation checks.
- Create standard operating procedures that define all processes and workflows for conducting studies.
- When integrating software with laboratory instruments and analytical devices, make sure to do so in a way that ensures data reliability and accuracy.
- Perform thorough validation testing to ensure custom-built software works properly.
Good Documentation Practices
Following Good Documentation Practices (GDP) will help demonstrate compliance across all regulatory frameworks.
- Create a document control system to manage all regulatory documents like policies, specifications, reports, and procedures.
- Create thorough test plans and scripts.
- Outline your system architecture and designs.
- Update your documentation each time you
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.
Following good software engineering practices (GSEP) will ensure that all software development and testing takes place in a controlled and compliant way.
This post was written by Justin Reynolds. Justin is a freelance writer who enjoys telling stories about how technology, science, and creativity can help workers be more productive. In his spare time, he likes seeing or playing live music, hiking, and traveling.