Harnessing DevOps for GxP Compliance: Streamlining Life Sciences Software Development

In software development circles you rarely hear the term GxP. However, achieving GxP compliance within the software development process can improve data safeguarding and promote trust. Furthermore, it can expedite your release cycles, improve software quality, and foster a culture of quality and efficiency within organizations. Sounds like a no-brainer, right? Why wouldn’t you want to start talking about and achieving GxP compliance? That’s why we wanted to share the benefits of integrating DevOps practices with quality management system (QMS) and manufacturing execution system (MES) software.

What Is DevOps?

DevOps is an innovative approach combining software development (Dev) and IT operations (IT Ops). This combination enhances collaboration and productivity and strives for faster deployment of features, fixes, and updates. Moreover, this approach promotes a culture of continuous integration (CI), continuous delivery (CD), and swift feedback. Plus, it utilizes automation to streamline building, testing, and releasing processes. Fundamentally, DevOps helps organizations:

• Achieve more efficient and reliable operational workflows.
• Reduce the time to market for new features.
• Ensure high quality and stability.

In today’s age of software delivery, DevOps in manufacturing is GxP. But it’s extremely complicated due to few widely established standards for software and IT operations – especially for software in the life sciences sphere. To learn more about DevOps concepts, read the DevOps Starter Guide provided by SPK and Associates here.

The System of Systems: CI/CD, QMS Software, and MES Software

CI/CD is a method highlighting the automation of integrating code changes from multiple contributors into a single software project. Having a CI/CD system in place also automates deployment, ensuring the software can be released to production anytime. This automation, whether controlled by developers, IT ops, or product management, is a competitive advantage in today’s world but it’s starting to become the norm.

CI/CD Explained

• Continuous Integration involves merging all developers' working copies to a shared mainline several times a day, minimizing integration challenges.
• Continuous Deployment goes further, automatically deploying all changes to the production environment after the build stage. This allows for faster and more frequent releases to customers without compromising quality.
• You may also hear the term Continuous Delivery, too. In this context, the new software is ready for distribution to its production state. However, a non-technical person or the customer decides when it goes into production. This is akin to how mobile apps are updated on your phone, or how printer firmware is available for update if you download it from a support website.

DevOps vs. QMS and MES

You’re probably extremely familiar with QMS software- and MES software-based solutions, so we won’t go into the basics of these systems. Instead, let’s cover how DevOps practices enhance and extend these systems.

Integrating QMS software and MES software, like the solutions offered by MasterControl, with CI/CD pipelines automates compliance and documentation while boosting real-time data visibility. This integration significantly enhances efficiency and minimizes errors, improving overall software quality. DevOps practices further streamline QMS and MES, enabling faster, reliable deployments critical for manufacturing integrity.

Without DevOps, speed often leads to issues. Conversely, collaborative DevOps aligns software updates with automated quality standards, enhancing compliance. Furthermore, continuous integration and delivery swiftly deploys software changes, reducing downtime and accelerating time to market. And to really hit the nail in the coffin, automation in DevOps improves accuracy, reduces human error, and elevates manufacturing execution systems' quality.

DevOps Tools

Tools such as Atlassian, GitLab, and others are critical for implementing secure and auditable CI/CD pipelines. This is essential for maintaining a high standard of software integrity and security. In fact, it consists of multiple components, including an improved culture between the two main constituents of

DevOps – the development team(s), and the IT operations team(s). If you look at DevOps simply as only a list of tools to solve problems, you’re selling it short.

That being said, well-implemented tools used in a collaborative and respectful environment can significantly enhance the software factory's ability to promptly deliver a valuable product to the marketplace. This image from Digital.ai, titled “The Periodic Table of DevOps Tools,” lists hundreds of commonly used DevOps. However, it does not encapsulate them all. So, I advise people to use this chart as an illustration of the capabilities of their available DevOps tools, not an exhaustive list. A non-technical executive’s eyes can easily glaze over when looking at the table. Instead, one should review the value of the capabilities in the main categories (the legend at the top of the image). Simply understanding what business value is provided by each category is imperative for both development, IT operations, and non-technical teams seeking value from DevOps in manufacturing. This is a more in-depth look at each category.

Challenges of DevOps in Manufacturing

The life sciences software development sector faces significant challenges, but these can be successfully overcome with a robust DevOps implementation emphasizing cultural values. Additionally, cultivating trust is the key to addressing issues like data silos, manual processes, and extended validation cycles within the life sciences manufacturing space. So, by adopting best practices for DevOps in manufacturing and encouraging collaboration between teams, you can ensure challenges are effectively addressed and overcome. Essentially this will improve the entire software development process.

Regulatory Compliance and Security Concerns

Life sciences manufacturers bound by U.S. Food and Drug Administration (FDA) regulations, including GMP and ISO 13485 standards, should focus on integrating DevOps practices meticulously. Implementing DevOps practices requires ensuring all processes, from software development to deployment, are compliant with these regulations. At times, the rapid pace of DevOps in manufacturing can clash with the meticulously slow-moving processes required for compliance. That means balancing DevOps' agility with compliance's methodical pace poses a challenge. However, it is achievable.

Dealing With Legacy Manufacturing Systems

If you rely on legacy systems already playing a critical role in their production processes you may be wondering how these align with DevOps in manufacturing. Typically, these systems often lack the flexibility and connectivity required for the agile and integrated nature of DevOps. So, yes, modernizing these systems without disrupting production or compromising on regulatory compliance is a significant challenge. But, not only is it achievable, it may be necessary for organizational success. Furthermore, attempting to integrate new software development practices with archaic technologies can slow down the adoption of DevOps and limit its effectiveness.

Product Quality = Quality Assurance and Risk Management

Product quality and patient safety is paramount. Therefore, implementing DevOps practices must not compromise the high standards of quality assurance (QA) and risk management that are integral to the life sciences industry. The challenge is balancing a swift, iterative development approach with thorough QA and risk assessments to ensure the end product is both safe and compliant. Balancing speed and innovation with the meticulous attention to detail required for life sciences products is a complex task – it requires careful planning and execution.

How DevOps Resolves Issues

Now we have outlined the key issues life sciences manufacturers face, let’s explain how DevOps offers viable solutions. DevOps:

• Promotes automation, collaboration, and streamlined workflows.
• Encourages continuous improvement through incremental updates.
• Allows organizations to gradually refine their software development processes.

This not only ensures compliance and innovation but also transforms software development into a strategic asset for life sciences companies.

What Have We Learned?

Harnessing DevOps for GxP compliance propels life sciences manufacturing forward, conquering challenges by integrating QMS software, MES software, and specialized tools. DevOps in manufacturing empowers life sciences for compliance, innovation acceleration, and superior software quality through continuous improvement practices. However, there are significant challenges posed to manufacturers looking to successfully implement DevOps.

At SPK and Associates, we realize support in this journey is the key to success. That’s why we work with clients to provide simple solutions such as discounts and education on tools designed for DevOps in manufacturing such as Atlassian, CloudBees, or GitLab. And, when our clients need on-the-tools assistance we support DevOps as a Service, ensuring your software factory is producing and meeting your compliance needs. After sharing our insights into the options for a great DevOps software development practice, it’s time to make your next decision – how will you progress with DevOps practices to achieve your company and product goals?