Sanofi

Curtis Bernard

The global life sciences sector is poised to enter a new era, one that will be driven by technology and the digital revolution. Widespread digital transformation has become a fundamental economic driver thanks to the widespread acceleration and acceptance of software as a service (SaaS) cloud solutions, from point of discovery to point of care. This has allowed businesses to save crucial amounts of money, time, and resources. Despite this ongoing shift in the industry, validation—a business-critical component shared by regulated companies—is still lagging. The purpose of validation is to make sure that the electronic records and signatures generated by these systems are equally dependable and durable as the paper ones they are replacing.

Testing is required to make sure that every system or service of this kind, from document control to data analytics, is appropriate for its intended use, runs smoothly, and upholds data integrity. Every time an upgrade takes place, these systems must also be retested to make sure there are no unfavourable effects on current functionality and that they continue to be in an inspection-ready form. Companies cannot choose not to do this. The FDA may decide to remove a product from the market or refuse to approve a medicine if software affects the quality of products or data in a clinical trial. Up until now, every validation procedure had to be thoroughly recorded since the rule in businesses under FDA regulation is that the evidence demonstrates you performed it. In business operations, 62 per cent of biopharma companies do not employ AI, and more than half do not currently use the cloud. In regulated life sciences organisations, falling behind outmoded processes and legacy methods results in a spiral of tech debt. Due to the time and effort needed to test upgrades or certify new systems, regulated businesses sometimes postpone or avoid updating important programmes. Businesses struggle to operate on old or heavily patched systems. Software companies have a hard time convincing users to use new features, which hinders innovation.

By the end of 2022, the global cloud computing market is anticipated to be worth USD 397 billion, with SaaS accounting for more than USD 145.3 billion of that total. By 2023, it's anticipated that 86 per cent of the life sciences sector will be using SaaS, up from the current 73 per cent. The downstream documentation burden has grown rapidly as businesses integrate more SaaS apps. To stay inspection-ready, IT and quality teams across the industry struggle to keep up with required vendor releases

Systems for automating CSA/validation lifecycle management, including vendor evaluation, risk management, change management, requirements management, protocol development and traceability, as well as documentation outputs, are currently available on the market. With the aid of these solutions, project teams may implement the CSA approach right away, utilising risk-based critical thinking continuously throughout the whole lifecycle of the computer system while sparing important human and material resources. The life sciences sector will inevitably change, particularly concerning validation. CSA will help organisations and their employees while we ride the tide of digital change, saving time and resources. Although the shift may seem daunting, there are ways to carry it out effortlessly and effectively. Business validation is essential, and starting with the newest tech-enabled solutions is the key to ensuring long-term business success.