The manufacturing facilities of life science companies can expect to have the U.S. Food and Drug Administration (FDA) show up anytime, announced, or unannounced. Once the inspection is complete, the […]
Blue Mountain recently conducted market research of the Compounding Pharmacies industry. From our research, we sought to uncover areas of the manufacturing process that require a more advanced solution for […]
Pharmaceutical compounding as we know today has grown exponentially since its origin – creating greater complexities than ever before. Drug compounding was once the job of local community pharmacists – […]
Adherence to cGMPs is vital to all Life Sciences manufacturers and data integrity is one component that impacts cGMP. A corporation’s data integrity is influenced by everyone at an organization. […]
Data integrity is vital to success in cGMP manufacturing. Companies can produce safer and higher quality products when they document reliable, accurate data. However, in order to ensure data integrity […]
Culture. With regards to the FDA, this word typically refers to growing microorganisms or other living materials in a medium. You will also find the word “culture” in The FDA’s […]
Now that I laid the framework for purpose-built EAM software and some core functionality requirements for regulated companies, I want to go into more detail about using EAM/CMMS features to […]
In the previous blog, I discussed the importance of using purpose-built software. Because we are a purpose-built EAM solution provider, we see many Life Sciences companies moving away from generic […]
Now that we’ve covered broader GMP issues in the previous 3 blogs, I want to discuss the overall role of an EAM/CMMS in managing compliance risks and some factors that […]
In the previous blog in this series, I discussed the FDA’s new Office of Pharmaceutical Quality and its overarching goals. There is no better summary of what the FDA hopes […]
