The FDA has finalized its Computer Software Assurance for Production and Quality System Software guidance — a long-awaited update that signals the end of “business as usual” for software validation in regulated industries. For decades, Computerized System Validation (CSV) has been the framework life sciences companies relied on. While it provided structure, CSV often created

Whether you’re running a biologics manufacturing plant, managing clinical trial data, or operating a quality management system, your computerized systems play a critical role in ensuring product quality and patient safety. But systems age, users change, processes evolve—and what worked flawlessly two years ago might be a compliance risk today. That’s where periodic reviews come

As biotech companies scale from clinical to commercial manufacturing, expansion of GMP facilities brings both exciting growth opportunities and complex regulatory challenges. One area that demands foresight is Computer System Validation (CSV) — the process of ensuring that software systems used in GMP environments are functioning as intended and in compliance with regulations such as

Setting up a GMP-compliant manufacturing site is one of the most critical steps for a biotech company transitioning into clinical or commercial production. In today’s digital landscape, implementing robust Computer System Validation (CSV) practices from the outset is essential—not only to meet regulatory expectations but to ensure seamless, reliable, and compliant operations across your production

As biotech companies move into clinical trials or commercial readiness, their Quality Control (QC) labs must scale quickly to support expanding operations. But scaling a QC lab isn’t just about acquiring more instruments or running more tests. It’s about validating smarter. Computer System Validation (CSV) becomes increasingly important—and complex—as companies prepare for INDs, BLAs, or

Launching a biotech company is an exciting journey, especially when it’s time to build your first GMP-compliant Quality Control (QC) lab. Amid the rush to select instruments, hire scientists, and finalize test methods, one foundational piece often gets overlooked—Computer System Validation (CSV). Whether you’re preparing for your first IND or simply trying to get your

Bringing an asset management system into a biotech environment isn’t just about picking the right tool—it’s about ensuring that tool is validated, compliant, and meets both regulatory and business needs. Whether you’re handling equipment calibrations, managing work orders, or ensuring traceable maintenance histories, Computer System Validation (CSV) is a critical step. Here’s what you need

Digitizing manufacturing with an MES is a big step, especially in regulated spaces like pharma and biotech. But alongside innovation comes responsibility—especially when it comes to compliance. Since MES sits at the heart of production, enforcing process controls and managing real-time data, it’s essential to validate the system to ensure it performs reliably, consistently, and

As biotech companies scale, user-friendly software systems—like EQMS, LIMS, or MES— can help standardize operations, ensure data integrity, and support regulatory compliance. But before signing a contract, it’s critical to better understand what the system can do and how it’s built, maintained, and supported behind the scenes. So, how do you dive into what really

In the biotech industry, regulatory compliance, data integrity, and operational efficiency are more than just priorities—they are critical to the success of any organization. As biotech companies move from paper-based quality management systems to Electronic Quality Management Systems (eQMS), it’s crucial that they select a system that is not only compliant but also scalable and