BioInformatics

Preventing Costly Batch Failures with AI-Driven Insights

Raffle and Survey

Top 10 Trends from SQA’s 40th Annual Meeting

What’s in Your Warehouse

In our previous post, we delved into the significance of an integrated inventory system and its potential benefits for biotech companies. Today, let’s take a step further and demystify the term “integrated inventory.” We will uncover what this system entails, how it differs from point solutions or conventional Excel-based methods, and why it is a game-changer in managing your inventory.

Inventory Wake-Up Call: Biotech’s Neglected Cornerstone

During the heyday of the genomics revolution, we had the good fortune to be part of Human Genome Sciences’ gene discovery department. Our challenge was to analyze human samples from all parts of the anatomy, stages of development, and states of disease to find genes being differentially expressed. When an interesting gene was discovered, we needed to find the specific sample in the freezer from which that sequence fragment was derived. Once acquired, our team would begin elucidating the entire gene sequence using a “primer walk” technique. Our success rate, an astonishingly high 98%, hinged on finding the right sample. From this, we learned firsthand the importance of establishing a reliable materials inventory on which to anchor scientific operations.

Interoperability: The Key to Increased Efficiency

Businesses create value by transforming raw materials into finished goods and selling them for a profit. There is an internal “supply-chain” that unfolds horizontally across most businesses with handoffs occurring between functions. For instance, one can envision a series of handoffs from purchasing, to receiving, to engineering, to manufacturing, to packaging, and finally to shipping.
Over dozens of informatics projects and several decades, we have found that these “functional handoffs” are a source of considerable friction within many businesses.

Post Deployment Services – Validation, Training, and SOPs

Are you considering a new IT system for process development, analytical testing, manufacturing, or clinical sample management? Consider the ways that BioIT can help you during the later stages of system integration. Move forward confidently and efficiently with our selection of services for this critical time.

The Paradoxes of Computer System Validation

Life Science companies who use computer systems to support regulated activities are compelled to perform computer system validation (CSV). CSV is valuable because it insists that you evaluate system performance against requirements and ensure regulatory fitness. But CSV is not an easy process. You must list requirements, perform risk assessments, and generate and execute test scripts to demonstrate compliance.