Agile and DevOps have transformed the SDLC (software development lifecycle) for a range of industries. But how can pharmaceutical companies benefit from a shift to Agile, DevOps, and related technologies like mobile test automation?
Pharmaceutical companies have to perform accurate CSV
Just as pharmaceutical companies have to comply with CGMP (Current Good Manufacturing Practice) regulations that are enforced by the FDA to ensure quality control for manufacturing processes and facilities, there are also strict guidelines for their technology components.
FDA-regulated industries like biotech and pharmaceuticals safeguard the public by using CSV (Computer System Validation) to ensure that each hardware and software component fulfills its purpose in-line with regulatory guidelines.
Quality standards have huge implications in the pharmaceutical industry, as failures could have wide-reaching and potentially lethal consequences. CSV ensures that each technology component behaves in a consistent and reproducible manner.
Agile can make CSV cheaper and more efficient
CSV is part of the testing process. It traditionally operated in a Waterfall development model, which meant it took place at the end of the SDLC – as software testing usually does.
However, it’s widely understood among software developers that using the Agile model and building testing into each stage of the SDLC can significantly reduce the cost of fixing software bugs, compared to the Waterfall model.
IBM’s Systems Sciences Institute has reported that it’s four to five times more expensive to fix a bug found after product release than during design – and up to 100 times more than a bug identified in the maintenance phase.
Using an Agile development model and testing on each short sprint might sound like more effort, but it can effectively reduce the overall risk of introducing errors during a lengthy development process, which could remain undetected until launch – which would be costly in terms of both time and budget.
Agile instead allows bugs and architectural flaws to be discovered quickly so that developers can immediately respond and improve their code.
Test automation can help pharmaceutical companies to achieve regulatory goals
Test automation and AI-powered testing are regarded as crucial technologies for overcoming the testing bottleneck that still holds back many Agile and DevOps teams today. But these technologies can also help pharmaceutical companies to improve their quality assurance and evolve their approach to CSV.
Software testing tools like Bitbar’s AI Testbot can be used to automate repetitive software tests to verify compliance and substantially increase the frequency of software testing at each stage of the SDLC.
Regression is a strong candidate for automation. It makes up 74% of all software testing and can boost an organization’s ability to regularly update an app without damaging its reliability or stability – which is crucial for medical apps that perform important tasks for end users.
Agile can help pharmaceutical companies to be more competitive
Traditionally, pharmaceutical companies have long software development lifecycles. Updates can be years apart due to the industry’s strict regulatory environment, which creates concerns about the resources and planning required for each update.
However, consumer products like mobile health apps are driving demand for faster development cycles in order to build and maintain competitive user experiences – which have the potential to clash with the industry’s strict regulatory requirements.
Medical apps were valued as a $1.4 billion global market in 2016 and are expected to grow at a compound annual growth rate of 21.4% between 2017 and 2025 to reach an estimated value of $11.22 billion by 2025. This growth is expected to be driven by global smartphone penetration, advancement in 4G and 5G networks, and government investment in mHealth initiatives.
Fortunately, industries like banking are already using Agile to balance regulatory obligations against commercial demands for competitive mobile apps – which sets a strong example for companies developing medical apps.
According to Forrester – who accurately predicted that sharp rise in organizational DevOps uptake in 2017/18 – it’s healthcare, banking, insurance, and manufacturing sectors that are leading the charge to leverage DevOps to support their business transformation.
Pharmaceutical companies may have a range of regulatory and consumer experience demands to balance. But as challenger banks are already demonstrating, they can use Agile, DevOps, and test automation to achieve this goal.