In this online exclusive, Rina Nir, managing director of RadBee, looks at why Agile and DevOps are the ultimate cure for pharma companies’ ailing computer systems validation process.
Software
If Computer Systems Validation (CSV) experts were doctors, they'd say that what most ails traditional large pharmaceutical companies are significant inefficiencies related to time, effort and budget in doing business as usual.
From unwieldy V-models to suffocating stacks of long-winded templates and laborious software development, it's clear that the old ways are choking progress. Luckily, the ‘cure’ is already proven and readily available.
In our digital world, the lifeblood of any successful company is speed — the faster they deliver software enhancements, the better. Over the last decade, Agile software development and DevOps have transformed the software industry. Today companies of all sizes, from startups to the Amazons of the world, have made huge leaps forward in reducing friction in the development and deployment chain to become more competitive and successful.
The pharmaceutical industry has been slow to adopt this trend. Software updates tend to be delivered in long cycles, with years-long gaps before an upgrade. The effort invested in each update is so large that software becomes almost frozen. The strict regulatory environment is often blamed for this; both Agile and DevOps need to be tailored to meet regulatory requirements, which necessitate a multidisciplinary approach and buy-in from many stakeholders. This makes for a challenge that is not only technically more complex, but also one that is rife with political and cultural challenges.
Furthermore, both regulatory compliance and Agile are in many ways a matter of interpretation, and thus often neither well understood nor implemented. Many organisations comply by creating a stifling, over-burdened quality system, and still others have poor Agile practices and do not see gains from adopting that methodology. It's quite common and altogether too easy to miss opportunities to find a smarter, faster, more streamlined approach to CSV.
Still, the business environment is changing now in ways that force the industry to rethink its approach and reinvent the software process. As a consultant to a wide variety of pharma companies in various geographical locations and cultural contexts, I'm seeing the movement towards more efficient CSV systems kick into high gear. One of the biggest facilitators of change is the huge trend of mobile health and apps. This is where software engineers from outside the life sciences sector are now getting involved with pharma in numbers significant enough to make a notable impact and help evolve the status quo. Digital health is another area where I see companies who are Agile-first. These businesses develop their products using more facile methods from the start, adding regulatory requirements as they move into the marketplace.
And so, the numbers of industry-disrupting companies are growing exponentially. Creating a reality where adopting a better way to do software is no longer just a good idea, but an actual imperative. It's literally a ‘do or die’ situation. Lesson learned by big pharma, too: today we're seeing many high-profile companies invest multi-millions into overhauling their software practices.
Agile and DevOps are effective change agents that improve and accelerate regulatory and quality assurance principles. Understanding these methodologies will not only help organisations create a bigger consensus and reduce objections, but will also help them get more out of the evolution of their CSV.
The key drivers of Agile and DevOps include:
- Discipline: Despite the first impression, Agile is not messy or improvised. Teams who master Agile apply a high level of self-governance and clearly follow process. They plan their work and track their progress with ticketing systems and code repositories — solid foundations to create authentic CSV records. Moreover, these teams measure their performance and are in the practice of striving for continuous improvement. The awareness that a process needs to be defined and followed through can be built upon for compliance purposes.
- Automation: DevOps methodology brings a lot of automation to the development and deployment cycle. It also helps compliance in the following important ways:
- Automates most routine, boilerplate tasks.
- Puts automatic checks in place to verify compliance (i.e., identify holes in traceability or a missing record).
- Leverages automatic tests, so that regression and unit tests can be executed much more frequently.
- Reliability and risk reduction: At its core, DevOps aspires to deliver software updates reliably. For example, by increasing the frequency of software updates, the actual scope of each update is much more limited, which makes the deployment cycle more controllable. This eliminates ‘big bang’ changes to software and long operational downtimes, and is for this reason a major incentive that should motivate quality assurance and CSV operators to take on DevOps.
- Pride and ownership: Right from the Agile manifesto through to DevOps principles, these methodologies encourage teams to strive for excellence and to take pride in what they do. This drives high level of engagement and ownership, which resonates very well in even the most regulated environment. In mature organisations, quality becomes everyone's business.
Focusing on these core values will help organisations leverage Agile and DevOps for regulatory compliance. It also creates the internal momentum and support necessary to move confidently into this new era where software changes are continuously delivered safely and in a compliant manner.
It's been said that software ‘eats the world’, so supporting the CSV revolution feeds all things pharma, from accelerating research into new drugs and all the way to safer production lines. Taking a healthy perspective that change is inevitable, and using the key drivers of that change to deliver on brand promises ensures the well-being of any pharma business — and its bottom line.