Bryan Ennis is the CEO and co-founder of SDRa regulatory technology company serving healthcare, life sciences and SaMD companies.
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The life sciences industry is on the brink of a new frontier: a future that is digital-first and technology-driven. With the massive acceleration and adoption of Software as a Service (SaaS) cloud systems – from discovery to point of care – widespread digital transformation is a key driver for businesses, saving businesses critical time, resources and spend. Despite this ongoing shift across the industry, one business-critical aspect common to regulated companies is lagging: validation.
Validation: making sure software does not affect patient safety
How do medicines and medical devices move from idea to point of concern? There are many steps in the process, but the foundation of these steps is the automated systems that manage the workflows and data along the way and the FDA requirements that ensure these systems are safe and work as designed.
Twenty-five years ago, the Food and Drug Administration (FDA) issued 21 CFR Part 11 (Electronic Records, Electronic Signatures), requiring life science companies to validate computer systems that directly or indirectly affect product quality or patient health and safety. . Validation is performed to ensure that the electronic records and signatures produced by these systems are as robust and reliable as, and equivalent to, the paper records being replaced.
Any system or service of this type, from document management to data analysis, must be tested to ensure they are fit for purpose, function correctly, and maintain data integrity. In addition, these systems must be retested each time an update is made to ensure that there is no adverse effect on existing functionality and that the systems remain in an inspection-ready state. This is not an optional activity for companies. If software affects the quality of products or data in a clinical trial, the FDA may remove a product from its shelves or deny approval for a drug. Until now, every validation activity had to be meticulously documented, as the rule in FDA-regulated industries is “documentation proves you’ve done it” – which translates to a lot of paper.
Paper? With all this technology at your fingertips, why do life sciences companies still rely on paper? Surprisingly, even in the past year, the life sciences industry has been slow to adopt innovative digital solutions. A recent report found that 62% of biopharma companies are not using AI in their day-to-day operations and more than half (51%) are not yet using the cloud. Lagging behind outdated processes and legacy approaches causes a cascade of “tech debt” in regulated life sciences companies: Regulated companies often delay or avoid upgrading critical applications because of the time and effort required to validate new systems or test upgrades To test. The end result? Businesses stumble upon systems that are outdated or heavily patched. Software vendors struggle to get customers to adopt new capabilities, which slows innovation.
treading water
The cloud computing industry worldwide will reach a value of $397 billion by the end of 2022, with SaaS accounting for more than $145.3 billion. About 73% of the life sciences industry uses SaaS, and by 2023 that number is expected to rise to about 86%† As companies introduce more SaaS applications, the downstream documentation burden has increased exponentially. IT and quality teams across the industry are struggling to keep up with vendor release mandates to stay inspection-ready.
Pressure on Industry 4.0 and Pharma 4.0 exacerbates this problem as life sciences companies rush to keep up with broader technology innovation trends. More SaaS systems result in increased intermediate release cycles for multiple applications, exponentially increasing the resource costs of managing a paper-based process. According to an statistic research: “As of 2019, a panel of CIOs and senior technology professionals reported that, on average, about 23% of their organization’s annual IT budget was allocated to quality assurance and testing.” Trying to solve a technology problem with a paper system is not going to make it. To resolve technical debt and accelerate the availability of up-to-date systems to support the business, life sciences companies must move from a reactive, paper-based process to a proactive, technology-driven, integrated process.
New Industry Standards
The FDA plans to release new guidelines for the Computer Software Assurance (CSA) initiative this year, but the content of these guidelines is already known in the industry. The agency encourages companies to modernize paper-based processes and replace them with technology that manages validation and builds more intelligence into the process. A focus on critical thinking, data-driven risk analysis, and advance supplier assessment provides significant value in identifying and mitigating risks early, as opposed to resolving issues after systems are released. Notably, it also places higher expectations on the software vendors serving life sciences to develop compliant products, increasing their responsibility for product quality. Ultimately, the FDA wants the industry to adopt more scalable methods, focus testing on what really matters, and improve inspectability — a move that will reduce effort and cost.
Technological solutions to technological problems
So how can we shift our thinking and apply the CSA model to validation as foresight? Fortunately, there are now CSA/validation lifecycle management systems on the market that can automate supplier assessment, risk management, change management, requirements management, protocol development and traceability, as well as documentation output. These systems enable project teams to integrate the CSA approach from the beginning of the project – by consistently applying risk-based critical thinking throughout the computer system lifecycle and saving valuable human and financial resources.
Change in the life sciences industry, especially when it comes to validation, is inevitable. As we ride the wave of digital transformation, CSA will benefit businesses and their employees, saving time and resources. The transformation can be intimidating, but there are solutions to make it happen seamlessly and successfully. Validation is a business necessity, and prioritizing the latest tech-enabled solutions from the start is key to driving long-term business success.
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