At BioIT Solutions, we’ve seen many of our customers start their digitization journey with stability testing. It’s a logical entry point, and in this article, we’ll explore why it’s the perfect candidate for a digital transformation and how it can lead to substantial time savings and risk reduction. Under 21 CFR Part 211, Section 166, … Read more
Implementing a Laboratory Information Management System (LIMS) can feel like walking a tightrope. The challenge is knowing where to draw the line during the pilot phase. Implement too little functionality, and the system may seem like more trouble than it’s worth. Add too much, and the project can spiral out of control, delaying your launch. … Read more
Inventory management is one of the most important jobs for biotech firms. Regulatory agencies demand strict record-keeping when it comes to manufacturing life-saving medicines, and there are major financial implications too. If you can’t find the materials you need when you need them, you’re wasting money, adding stress, and possibly putting critical experiments at risk. … Read more
In the complex world of biomanufacturing, precision is everything. A small error can cascade into monumental consequences, not just for the manufacturers but also for the patients depending on these life-saving therapies. A stark reminder of this reality came during the production of COVID-19 vaccines when millions of doses had to be destroyed due to … Read more
During the early 1990s, we had the good fortune to participate in the gene sequencing revolution. At the time, the human genome remained unsequenced, and the scientific community held fervent hope that unlocking its mysteries would lead to groundbreaking medicines and cures. Our work involved preparing human tissues from various organs, disease states, and developmental … Read more
When my daughter visited last week, she had a sore throat, so I ran out to buy cough syrup—only to find I already had a full bottle at home. This reminded me of a customer who had a similar problem. Their warehouse struggled with material scrap due to paper and Excel tracking. After analyzing the … Read more
In our last post, we heard about a troubled manufacturing campaign where intermittent batch failures cost the company >$1M per batch. One remedy was to capture batch data at the Point-of-Use (POU) and make it available to AI/ML engines for real-time analysis. This capability is typically provided by Electronic Batch Records (EBR). But EBRs are … Read more
