GxP Compliance Checklist: What is GxP Compliance & Why Does it Matter for 2026?
For software teams building tools and systems for regulated environments, GxP isn’t an afterthought to quickly fill out. It shapes how you design, test, deploy, monitor, and document software across its lifecycle. Today, we’re going to discuss what GxP is, why it matters more than ever, cover a practical checklist to get you started, and how recent trends like AI have affected compliance.
What is GxP Compliance?
GxP (short for “Good-[x]-Practice”) is the umbrella of quality rules and expectations that a variety of industries must meet to prove that products, processes, and the data that support them are safe, effective, and trustworthy. The “X” is replaced by the relevant discipline, such as GMP (Good Manufacturing Practice) or GCP (Good Clinical Practice). For software teams, GxP details how electronic records, processes, and controls need to be designed, proven, and maintained so both auditors and regulators can trust the data that your system produces.
What does GxP Cover?
GxP covers a variety of subject areas, but the most relevant ones for software teams include:
- GMP (Good Manufacturing Practice): Process controls, batch records, manufacturing systems, etc.
- GLP (Good Lab Practice): Lab workflows, instrument interfacing, study documentation, etc.
- GCP (Good Clinical Practice): Clinical trial systems, eCRFs, source data, investigator oversight, etc.
- GDP (Good Distribution Practice): Primarily supply chain and safety reporting systems.
Software teams must ensure that their apps and systems meet the various requirements for creating, securing, signing, and archiving electronic records. This enables your customers in biotech and other regulated fields to meet their end of the compliance deal with audit trails, access controls, electronic signatures, record retention, and more.
Why is GxP Compliance Important?
The stakes are high when it comes to regulated products and systems. Any lapse in compliance could risk patient safety, product recalls, regulatory penalties, and more. As a software team, you should keep in mind that regulators need to trust the data you produce — in other words, demonstrable data integrity. Your systems may be inspected or audited for controls, validation evidence, and lifecycle management, so GxP compliance has to be included from the start. For teams and software that fail to meet compliance, it often results in not only unverifiable or corrupted data, but also reputational harm and financial penalties for everyone involved. GxP matters because it assures customers and regulators of the quality, reduces customer (and vendor) risk, and leverages software process artifacts as evidence that auditors can inspect.
GxP Compliance Checklist
Documentation
- Controlled and approved SOPs with version control and archival
- Documented traceability from requirements → tests → results → defects
- Validated system lifecycle and assurance plans (risk-based, CSA/CSV, GAMP)
- Defined scope and objectives for GxP software assessments
- References to applicable regulations (FDA, EMA, Annex 11, Part 11)
- Disaster recovery and contingency planning documentation
- Validation documentation templates:
- URS
- FRS
- Configuration specs
- Test scripts
- Trace matrices
- Validation summary
- Master validation plan
- System inventory
- Decommissioning plans
Data Integrity & Security
- ALCOA and ALCOA+ compliance (complete, consistent, enduring, available)
- Audit trails that are tamper-evident, timestamped, and fully traceable
- Role-based access control, authentication, e-signature support (Part 11 / Annex 11)
- Encryption at rest/in transit, cloud validation, and access confidentiality
- Real-time data traceability with instrument and third-party integration
- IKQ/OQ/PQ environment qualification to ensure validated deployment
- Controls for physical devices and networks (PLCs, access control, removable media policies)
- Backup policies and verification, including periodic restoration checks
- IT Disaster Recovery Plan focused on data governance
- Secure password policies, unique user logins, and audit trail enforcement for lab and device systems
Processes & Procedures
- Risk-based validation lifecycle processes (system classification, risk assessment)
- Formal change control (change requests, impact analysis, testing, approvals)
- Internal and external audit programs, deviations/CAPA processes, and periodic reviews
- Integrated QMS workflows (document control, audit findings, training, deviations, CAPA)
- Assessment of system scope, gap analysis, and regulatory requirement mapping
- QMS templates for audit management, supplier quality, calibration, risk, and training modules
- Implementation of EQMS for CAPA, audit, change management, and supplier controls
- Ongoing continuous monitoring and compliance dashboards (real-time visibility)
- Identification of GxP-critical systems (LAN/WAN, backup systems, physical access systems)
People & Training
- Documented role-based training plans, matrices, and training execution records
- Regular competence assessments, including of third-party/vendor staff
- Organizational chart and quality governance structure that are maintained and up to date
- Skills matrix to assess data integrity knowledge across the team
Change Management
- Structured change control: documented requests, impact assessments, testing, and approvals
- Version control for software, documentation, and AI/ML models—including rollback capabilities
- Periodic review and revalidation for system changes or upgrades
- Supplier/vendor change notifications and qualification controls for third-party systems
How is AI Affecting GxP Compliance?
The advances in machine learning and AI that we’ve discussed previously are also changing how regulated workflows operate:
- As a tool used within regulated processes.
- As part of regulated software products.
- As an accelerator for compliance work.
The result is a variety of different impacts that devs and project managers must consider so their products not only meet requirements but surpass competitors in this area. There are new validation and lifecycle demands, from training data provenance to drift monitoring. It’s no longer enough to validate a status algorithm once — it has to be governed, retrained, and monitored on an ongoing basis. This data provenance and traceability also need to be applied to transformations, maintaining unchangeable records of all datasets and how decisions were made. Regulatory organizations and laws are also catching up to AI use, bringing necessary transparency, documentation, and conformity requirements to AI systems (especially in fields that GxP applies to). This changes how lifecycle management, testing, monitoring, and more are performed in the age of AI, so your tools need to be able to keep pace.
Read more about AI’s impact on software development here.
Inflectra Software: GxP Compliant Solutions for Biotech, Pharma, & Life Sciences
Our suite of Spira software platforms (SpiraTest, SpiraTeam, and SpiraPlan) helps ensure your products’ compliance from ideation to deployment and ongoing maintenance. They’re designed with regulated industries in mind for unmatched QA capabilities, so software teams can streamline compliance without sacrificing visibility or control.
- Our traceability of Requirements > Tests > Defects is industry-leading, providing true end-to-end visibility that helps teams build evidence that auditors expect.
- Our audit trails and immutable history document and preserve field changes (who made the change, what changed, when they changed it) to easily print audit evidence with artifacts.
- Our built-in e-signatures and approvals make it easy to document patterns for managing approvals, with document-centric signatures as an option.
- Our risk management and test planning features put Spira ahead of any QA software available, offering tools like risk registers, risk-based testing workflows, and more.
- Our integrations and automations make QA (start to finish) easier for your team via APIs, integrations with major tools like AWS and Jira, automated workflows, and other user-driven features to reduce manual validation work.
See how to use SpiraPlan for GxP CFR Part 11 Projects here.
Note: Using a tool like Spira does not remove the developer’s obligation to perform appropriate risk assessment, qualification/validation, and to maintain SOPs and training records. Inflectra’s products provide functionality that enables compliance, but the regulated organization remains responsible for governance, configuration, and assurance choices.
