By Stefan Siegle (ERNI Germany)
In many life sciences companies and other highly regulated industries, regulations are still perceived as barriers to innovation. Terms like 21 CFR Part 11, GAMP 5 or EU GMP Annex 11 often trigger resistance – they are associated with bureaucracy, lengthy approval processes and mountains of documentation. But this perception is misleading. It is not the regulations themselves that slow progress, but rather the overly cautious way in which they are often interpreted.
When compliance is viewed solely as a control mechanism, its real purpose is lost. Regulations are not designed to stifle innovation but to ensure reliability, traceability and product quality – the very same objectives pursued by modern software engineering practices.
The misconception: Regulation as the enemy of agility
Many organisations equate compliance with bureaucracy. Out of fear of audits and deviations, they over-engineer their processes – every line of code requires a form, every change a signature. The result is predictable: development cycles slow down, teams lose autonomy, and innovation drowns in paperwork.
However, regulatory authorities do not demand such behaviour. The US Food and Drug Administration (FDA), for example, explicitly emphasises in its Computer Software Assurance (CSA) Guidance that critical thinking should take precedence over excessive documentation. The core principle is risk-based decision-making: changes that could affect product quality or patient safety must be tested rigorously, while routine updates can be handled with agile methods.
Unfortunately, many organisations apply the strictest possible validation level to every system and process, regardless of risk. This turns a flexible framework into a rigid cage. Ironically, this over-compliance increases complexity – and with it, the potential for real errors.
Software engineering as the foundation of regulatory excellence
Modern software engineering already provides the tools to meet compliance requirements efficiently – if used properly. Continuous Integration and Continuous Delivery (CI/CD), automated testing and consistent version control create a digital memory of all development activities. Every change, test run and deployment is traceable and time-stamped.
This transparency directly satisfies the regulatory principles of validation and traceability. Traditional documentation-heavy approaches try to reconstruct this information manually – a slow, error-prone and expensive process. In contrast, modern DevOps pipelines generate the same evidence automatically: build logs, test reports, pull requests and commit histories are immutable and verifiable. This means regulatory evidence is produced continuously, as a natural outcome of good engineering.
Take a simple example: when a team develops a feature that processes patient data, they define the user story with clear acceptance criteria. Automated tests validate compliance, and the CI/CD pipeline records each code change along with author, timestamp and results. The process is transparent and verifiable – fully aligned with regulatory expectations.
Cultural change, not just tool change
Technology alone is not enough. Software excellence requires a cultural transformation. Many organisations invest in new tools but maintain outdated mindsets. Implementing Git, Jira or test automation does not automatically create quality. True excellence emerges when Quality Assurance, Regulatory Affairs and Engineering collaborate as equal partners.
A key enabler is early involvement of quality and compliance experts in the development process. Instead of merely approving validation documents at the end, they should help shape requirements, tests and verification from the start. This transforms quality teams from gatekeepers into enablers.
For this to work, both sides must develop a shared understanding of risk and evidence. Developers need to treat regulatory needs as a design parameter – just like performance or security. Likewise, regulatory professionals should embrace agile, iterative methods as opportunities for better, faster and more reliable validation. When both perspectives align, compliance becomes an integral, value-adding part of the engineering process.
Stepwise implementation and organisational maturity
Achieving ‘compliance by design’ is a journey, not a switch. The best way forward is incremental. Pilot projects are an effective starting point: choose a low-risk system and experiment with automated testing, digital traceability and lightweight approvals. Collect data, document the outcomes and review them jointly with regulatory and quality teams.
Early wins build confidence – both internally and with auditors. As maturity increases, the approach can be scaled to additional systems. At the same time, training and coaching ensure that teams understand why certain evidence is required, not just how to produce it. People who understand the intent behind a regulation can generate better, leaner and more relevant documentation.
Another key practice is distinguishing between validated and non-validated systems. Not every component surrounding a regulated product needs to meet full validation standards. By focusing validation efforts on what truly matters, organisations can reduce overhead and accelerate delivery – without compromising safety or compliance.
Compliance as an outcome of quality – not an obstacle
At its core, compliance is not an additional burden. It is the natural by-product of sound engineering. Excellent software practices do not contradict regulatory requirements – they fulfil them more effectively. Automated testing, reproducible build environments, structured requirements management and transparent workflows inherently produce reliable, auditable and compliant systems.
The old dichotomy between ‘the developers’ and ‘the regulators’ is obsolete. Compliance is not the opposite of agility; it is what happens when quality is built into every step. When organisations adopt this mindset, they transform compliance from a bureaucratic obligation into a strategic advantage.
Ultimately, both regulation and software engineering share the same mission: ensuring safety, trust and quality. Companies that embrace software excellence as the foundation of compliance not only meet regulatory expectations – they exceed them. And in doing so, they deliver better products to market, faster and with greater confidence.
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