Stop Blaming Regulations: How Software Excellence Satisfies Compliance

Your stakeholders expect you, as a technology leader in life sciences, to master generative AI, implement next-generation sequencing platforms, and deploy digital twins for clinical trials—all while accelerating innovation, increasing delivery speed, and managing costs. And of course you have to do this with your existing team. Just don’t forget to maintain flawless system uptimes and resolve everyday operational issues. Other than that, your job is easy—right?

Technology may not be what’s holding you back amid these mounting pressures. The real barrier might be misinterpreted regulatory requirements.

Many life sciences organizations constrain themselves with hypercautious interpretations of compliance demands. Life sciences companies waste millions of dollars in market opportunities because they create elaborate approval processes that regulatory bodies don’t mandate. They apply pharmaceutical validation approaches to software development, claiming GxP requirements justify the need for signatures and approvals.

IT teams often hear, “We need signatures for 21 CFR Part 11.” But tools that aren’t directly part of GxP-regulated processes don’t require the same level of validation as systems that directly impact product quality or patient safety (ISPE GAMP 5 Guide, Second Edition). The FDA’s Computer Software Assurance (CSA) guidance actually emphasizes “critical thinking” over documentation and “testing that matters” over comprehensive test scripts. When you read the actual regulations, you’ll find much more flexibility than the industry commonly practices.

Of course you should consult your legal and compliance teams before changing compliance practices. This guidance serves as a resource, not definitive instruction.

The real damage occurs when the compliance mindset overtakes IT’s focus on technology creation. Quality departments raise objections like, “How can we ensure proper review without formal approvals?” But formal approvals slow IT organizations down. Regulatory agencies require evidence of controlled software development—but they don’t dictate how to produce it. Modern development tools can generate required documentation while teams work at speed, resolving the supposed conflict between innovation and compliance.

The Fundamental Shift: Natural Compliance Through IT Expertise

Software developers spend years mastering engineering practices that create quality and consistency. Technology leaders should respect their teams’ professional expertise rather than diluting it. Forcing your teams to become regulatory experts by teaching them GxP terminology and requiring them to fill out compliance templates wastes their talent.

Let IT Be IT. Allow technology teams to follow software engineering best practices that naturally meet compliance objectives.

Modern software testing practices ensure higher quality than traditional manual validation. Continuous integration catches defects within hours instead of months during formal testing phases. Automated test suites run thousands of scenarios with each code change, providing more comprehensive coverage than manual test scripts ever could. Unit tests verify individual components; integration tests confirm system interactions; and automated regression tests ensure new changes don’t break existing functionality. This continuous testing approach creates a more reliable system while automatically documenting test results for compliance.

Using user stories to manage requirements provides clearer traceability than traditional requirements documents. Legacy methods separate requirements from development, which can lead to long review cycles. User stories, on the other hand, integrate acceptance criteria directly into the development process. Each story links to specific code changes, automated tests, and deployment records, creating an unbroken chain of evidence from requirement to implementation. Version control systems automatically track how requirements evolve based on stakeholder feedback, which eliminates the need for separate change control boards while providing superior audit trails.

Development tools generate extensive compliance documentation during the engineering process. Version control systems maintain complete histories of every code change with developer attribution and timestamps. Continuous integration pipelines capture test results in machine-readable formats that provide better evidence than manual screenshots. Deployment automation documents every change from development to production with full traceability. These tools create richer compliance documentation by preserving the actual evolution of software rather than collecting signatures on point-in-time snapshots.

Stakeholder demonstrations and digital approvals verify that systems work as intended more effectively than do separate validation phases. When users participate in sprint reviews and approve features against acceptance criteria, they create objective evidence of system functionality. Recorded demonstrations capture exactly how features work, while digital approval workflows document stakeholder acceptance. This reduces or even eliminates the need for testing phases while providing auditors with direct evidence that the system meets user needs, addressing the core purpose of validation requirements.

These modern practices can satisfy regulatory requirements without additional overhead. Development tools align with FDA 21 CFR Part 11 through authenticated logins and timestamped audit trails. Automated testing and continuous integration align with EU GMP Annex 11’s requirements for system verification. User story traceability maps directly to ISO 13485:2016’s design control requirements. Even GAMP 5 categories find natural parallels in agile artifacts. By following software engineering best practices, teams naturally produce evidence regulators require, freeing quality professionals to focus on risk assessment rather than chasing signatures.

Starting the Transformation Journey

Implementing these modern practices requires technical expertise and organizational change. Begin by comparing your development process to industry best practices and identifying gaps between your practices and high-quality standards in less regulated industries.

Start with a small pilot project that’s meaningful but contained. Involve regulatory teams from day one (many transformation efforts fail when these experts are consulted too late). Form a working group with IT, Quality, and Regulatory Affairs to map compliance requirements to IT controls and development artifacts. When regulatory professionals help design the approach, they become allies rather than gatekeepers.

Review your Quality Management System to identify requirements that add documentation but not quality. Look for opportunities to replace document-based evidence with data-based evidence that still meets control objectives, and document these agreements formally to ensure consistency during audits. This critical review often reveals legacy processes that were created to satisfy outdated interpretations of regulations.

You’ll likely encounter resistance. Quality professionals may worry about regulatory risk, while IT teams might resist changing established practices. Address these concerns by emphasizing that this approach produces better evidence, not less. Show how modern tools create more comprehensive audit trails than manual processes can. The FDA’s CSA guidance acknowledges that excessive documentation can actually decrease quality by diverting resources from substantive testing.

Build executive support by emphasizing business outcomes that matter to leadership while addressing stakeholder concerns. Focus conversations with skeptics on shared goals: Everyone wants safe, effective products delivered efficiently to patients. Demonstrate concrete benefits like faster delivery, higher quality, and better audit readiness—all while satisfying regulatory requirements. Success metrics from pilot projects are particularly persuasive to executives who need to see measurable improvements before expanding the approach.

Software Excellence as Compliance Strategy

The regulatory framework exists to protect patients. The approach described here respects that mission while recognizing that evidence of quality comes from how software is built, not just how it’s documented. Development tools capture more complete, accurate information about system changes than manual documentation ever could. This creates better visibility into the actual state of systems, improving compliance and safety.

Companies often frame regulatory requirements as barriers to innovation. They aren’t. The practices described here demonstrate how life sciences organizations can adopt modern development approaches while meeting their regulatory obligations. When software excellence drives compliance strategy, everyone wins—especially patients.

Disclaimer: Always consult your legal and compliance teams before changing compliance practices. This guidance serves as a resource, not definitive instruction.

 Tom Godden and Ian Sutcliffe