Understanding current Good Manufacturing Practices (cGMP) in the pharmaceutical industry can be challenging. That’s why Quality professionals in the pharma industry actively seek to understand the details of cGMP regulations. In most cases, they also...
Quality control (QC) processes can be a significant bottleneck in the smooth functioning of a pharmaceutical manufacturing unit if a lot of material gets stacked into either incoming raw material or the quarantined area before it gets approved. The c...
What Are ATMPs? ATMPs is an acronym for Advanced Therapy Medicinal Products. These medicinal products are based on genes, tissues, or cells. Research shows that ATMPs provide promising therapeutic applications for Alzheimer's disease, cancer, muscula...
To successfully get a drug FDA approved, the data on the drug’s effects need to be reviewed by the Center for Drug Evaluation and Research (CDER), which in turn needs to determine that the drug’s benefits notably outweigh its known and potential risk...
For thousands of years, our ancestors have used the cannabis plant to treat illnesses. The medicinal use of the cannabis flower is made possible thanks to its hundreds of chemical compounds that create pleasant sensations, feelings of relief, and hea...
Tech innovations are driving the rapid evolution of everything humans do, and auditing is no exception. Since 2020, remote or virtual audits have become commonplace, born out of necessity in a time when on-site audits were simply impossible. Due to t...
Stacks of paper, what a hassle! Staying on top of who printed what, where, and when is a common struggle for many life science companies. Document reconciliation is even more of a challenge. Printing may be unavoidable, but staying compliant and keep...
Most pharma and MedTech companies have had digital transformation on their to-do list for quite some time. Unfortunately, only a few (roughly 20%) have actually pivoted from doing digital to being digital.
Paper strewn about the company is a regulation nightmare, especially for industries in the Life Sciences. It’s not just about supervising who has access to printed documents (and who printed them off in the first place), but also about collecting and...
Modern healthcare is being shaped by a marked rise in technology use—based on the next generation of personalized medical care. Science, to this end, is bolstering patient centricity, especially as data becomes increasingly available in the public do...
Scilife has a new module! Finally, risk management is made a whole lot simpler, as well as accessible by everyone. In our webinar on Scilife's new Risk Assessment module, CEO Filip Heitbrink discusses:
How Smart Can Smart Software Be? Smartphones, smart cars, smart cities, smartwatches, smart locks… and the latest addition to the list: Smart Quality Management Software! In today’s smart age, we are surrounded by many smart tools powered by cutting-...
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