Regulatory implications are critical to your foundation
Agile compliance can help you and your company build high-quality software for the life sciences industry that is cost-effective, complies with patient safety considerations, and is delivered on time. Its activities and artifacts allow your teams to apply Agile development methods to build high-quality systems that meet the relevant regulatory and industry standards.
Agile + GxP: the key principles
- Iterative validation: validate in sprints, not waterfalls — smaller, faster, more traceable.
- Risk-based testing: focus validation effort on highest-impact functionality using CSA principles.
- Continuous compliance: automate evidence generation so compliance keeps pace with delivery.
- Quality-by-design: build quality controls into the development process, not bolt them on after.
Regulatory considerations should be included from the start of your software development lifecycle (SDLC), not as an afterthought. Legacy quality management systems (QMSs) are based on an old-school mindset of a phase-gate approach and can’t keep up with the fast-paced Agile methodology and time-to-market demands. The waterfall software development method often requires extensive documentation upfront, long before actual system behaviors are known. Sequential phase-gate development produces long cycles between integration points and delays feedback; it also tends to defer compliance activities to the end of the project when it may be too late or too costly to perform them.
Regulations and standards do not prescribe a particular lifecycle model, so you have the flexibility to create an SDLC process that works for your company and environment. With compliance built-in, you have the following:
- Safety and risk management
- Quality assessments throughout integration and testing
- Constant feedback and team accountability
- Focus on completing gates, activities, and artifacts
- In-line approval for artifacts
- Traceability of requirements to testing
- Compliance tasks (e.g., audits and assessments) added to the backlog
- Automated verification and validation activities
Having compliance built into the development process—and automated when possible—helps to ensure that you get feedback early and often and that compliance activities are being met. While validation is time-consuming, testing in small batches can save you considerable time and enable you to meet or beat your deadlines. All the necessary pieces required for compliance—reviews, audits, and signoffs—are included in your definition of done.
It's time to get away from creating documentation for the sake of creating it. When you adopt the computer software assurance (CSA) methodology, you are taking a risk-based approach to building safe and effective software that helps you achieve Agile compliance.
Don’t miss another deadline or experience disappointing business outcomes. USDM Life Sciences can help you assess your current processes, develop your SDLC, and maintain continuous compliance. We welcome the opportunity to discuss your GxP business challenges. Contact us today.
Agile GxP sprint checklist
- Sprint planning: include validation and compliance requirements in sprint scope.
- Risk assessment: classify features by GxP impact before development begins.
- Automated testing: build validation test cases alongside functional tests.
- Evidence capture: generate audit-ready documentation during the sprint, not after.
- Sprint review: include quality and compliance reviewers in the demo cycle.
- Continuous deployment: gate releases on compliance checks before production promotion.
Talk to USDM about designing agile compliance programs that let your development teams move faster while maintaining GxP quality and regulatory readiness.
FAQ: Agile Compliance for GxP
Can agile work in regulated environments?
Yes. Regulatory agencies including the FDA support risk-based, iterative approaches to software validation. The CSA framework specifically enables agile-friendly validation practices when quality controls are designed into the development process.
How do you validate software in agile sprints?
Break validation activities into sprint-sized increments: risk-classify features, write test cases alongside development, automate evidence capture, and review compliance at each sprint demo. This replaces the traditional waterfall validation phase.
What is continuous compliance?
Continuous compliance means generating validation evidence and maintaining audit readiness as an ongoing process — not a one-time project. Automated testing, monitoring, and documentation tools support this model.
Does USDM support agile GxP implementations?
Yes. USDM helps life sciences organizations design agile-compatible validation strategies, implement continuous compliance programs, and deploy quality-by-design practices across regulated technology platforms. Contact USDM to get started.