For over two decades, life sciences companies have relied on paper-based validation to ensure compliance with regulatory requirements such as the FDA’s 21 CFR Part 11. While instrumental in the development of the computer validation framework, this legacy approach has become incompatible with today’s digital landscape, prompting the need for updated best practices such as ISPE GAMP 5 Second Edition, which now serves as the industry’s primary validation reference.
The legacy paper-based approach to validation, which was designed to ensure strict adherence to regulatory compliance, has now become inefficient in today's fast-paced digital life sciences industry, creating a paradox as the need for extensive paper documentation has made it a huge impediment to agility, efficiency, and timely compliance.
This rigid waterfall approach has slowed software development and deployment, making frequent updates costly and time-consuming for life sciences businesses that, like any other business, rely on cost savings to remain afloat.
As cloud-based systems, AI, and interconnected digital infrastructures slowly replace on-premises setups, the need for dynamic and more efficient validation methods is set to only grow in significance as life sciences companies seek to address the challenges of continuous compliance, real-time monitoring, and the increasing complexity of modern digital ecosystems.