In highly regulated industries such as healthcare, finance, and aerospace, compliance is a critical component of risk management and operational integrity. Regulatory bodies impose strict standards to ensure software reliability, data security, and transparency. Whether it's FDA regulations for medical devices, GDPR for data protection, or ISO standards for quality management, organizations must demonstrate that their software testing processes meet these stringent requirements.
However, achieving and maintaining compliance in software testing presents some challenges:
- Ensuring full traceability – regulatory audits require a clear link between requirements, Test Cases, Executions, and Defects. Without proper tools, maintaining this visibility can be overwhelming;
- Managing documentation overload – compliance demands detailed test evidence, approvals, and reports. Manually handling these documents increases the risk of errors and inefficiencies;
- Keeping up with evolving regulations – Regulatory frameworks continuously evolve, requiring organizations to adapt their testing processes accordingly;
- Balancing compliance with agile development – Modern development methodologies emphasize speed and flexibility, yet compliance processes often introduce bottlenecks that slow down releases.
How Xray Enterprise supports compliance
Built-in traceability and auditability
One of the biggest compliance challenges is ensuring end-to-end traceability across testing activities. Xray Enterprise provides:
- Full test traceability – every Test Case, Execution, and Defect is linked to Requirements, making it easy to demonstrate coverage and compliance;
- Audit logs and version control – All changes to test artifacts are recorded, ensuring a clear audit trail for regulatory reviews;
Customizable workflows for regulatory processes
Xray Enterprise works seamlessly with Jira’s native capabilities to support regulatory needs through customizable workflows and access controls. In addition, it offers enhancements that help streamline documentation and reporting:
- Custom approval workflows (via Jira) – Configure structured review and validation steps that reflect regulatory requirements using Jira’s workflow engine;
- Role-based access control (via Jira) – Leverage Jira’s permission schemes to restrict test management actions and ensure data security;
- Streamlined compliance reporting – Xray Enterprise offers enhanced reporting options that simplify the generation of audit-ready documents, helping teams reduce manual effort.
How Xray Enterprise strengthens compliance workflows
Xray Enterprise builds on Jira’s robust workflow and permission capabilities by adding test-specific features that support compliance efforts. While many compliance needs are addressed through configuration and integrations, Xray Enterprise enhances this with:
- Improved traceability tools to connect requirements, tests, and defects;
- Structured support for validation and approvals, including electronic sign-offs;
- Simplified reporting with templates that help reduce manual documentation overhead.
These features help teams reduce compliance risks, improve audit readiness, and maintain quality assurance, even in highly regulated environments.
Compliance across industries and standards
Xray Enterprise supports compliance with a wide range of regulatory frameworks by aligning test management with industry standards. Whether you’re in healthcare, finance, or aerospace, Xray Enterprise helps you maintain traceability, auditability, and structured validation — all essential for meeting compliance requirements.
Supported regulatory frameworks include:
- Healthcare & Pharma: FDA 21 CFR Part 11, GxP, HIPAA
- Finance & Security: GDPR, SOX, PCI DSS
- Automotive & Aerospace: ISO 26262, DO-178C
- General Quality & Risk Management: ISO 9001, ISO 27001
By centralizing test data, enabling electronic approvals, and generating audit-friendly reports, Xray Enterprise helps teams across industries demonstrate compliance with minimal friction.
Best practices for Compliance-Driven Testing
By implementing structured workflows, automating reporting, and maintaining audit readiness, organizations can streamline compliance without slowing down development.
Establishing structured testing workflows
A well-defined testing process is the foundation of compliance. Xray Enterprise enables teams to:
- Define and enforce approval workflows – ensure Test Cases, Executions, and Reports follow a structured validation process;
- Use requirement-based test management – link test cases to regulatory requirements to demonstrate full coverage;
- Implement risk-based testing – prioritize testing efforts based on criticality, aligning with standards like ISO 26262 and FDA guidelines.
Automating compliance reporting
Manual documentation is time-consuming and prone to errors. Xray Enterprise simplifies compliance reporting by:
- Generating real-time audit reports – provide clear, up-to-date insights into test execution, traceability, and defect tracking;
- Utilizing pre-configured templates – ensure reports align with industry standards and regulatory requirements;
- Integrating with external documentation tools – seamlessly export reports for regulatory submissions or audits.
Maintaining audit readiness with Xray Enterprise
Regulatory audits can be complex and demanding, but Xray Enterprise ensures teams are always prepared by:
- Maintaining a complete audit trail – every change to test cases, executions, and defects is logged for full transparency;
- Enforcing electronic approvals – secure sign-offs ensure regulatory validation requirements are met;
- Ensuring data residency compliance – Xray Enterprise supports regional data storage to meet GDPR and other privacy regulations (learn more in our How Data Residency safeguards compliance & security blog).
Learn how to simplify regulatory compliance with Xray Enterprise
Ensuring compliance doesn’t have to be complex. With Xray Enterprise, you can streamline regulatory adherence through structured workflows, automated reporting, and end-to-end test traceability.
✅ Reduce compliance risks;
✅ Automate audit-ready documentation;
✅ Maintain full test traceability.
Learn more about how Xray Enterprise supports compliance and book a demo today! Book a Demo today.