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What’s the Difference? FDA 21 CFR Part 11 vs EU Annex 11
This article explains 21 CFR Part 11 and EU Annex 11 regulations for electronic records and signatures in GMP-regulated activities. It covers compliance requirements, benefits,…
What is Industry 4.0 Predictive Maintenance? Benefits & Examples
Industry 4.0, or the Fourth Industrial Revolution, is characterized by massive improvements in artificial intelligence and machine learning. All around us, our devices are becoming…
The Complete Guide to Computer System Validation: IQ, OQ, PQ,
In our industry, Computer system validation is the process of ensuring that a computer system is fit for use and is functioning according to user…
What’s the Difference? FDA Form 483 Observations and Warning Letters
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 Role of EAM in Mergers and Acquisitions
As the Life Sciences industry is being driven by corporate M&A, it is essential that organizations effectively leverage enterprise asset management systems (EAM) to meet…
The Compliant Landscape of Compounding Pharmacies
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…
The Role of a CMMS in the Asset Induction Process
When thinking about the assets in a facility and asset induction, calibration and facilities managers are concerned about their reliability, availability, maintainability and criticality to…
The Industrial Internet of Things and the Life Sciences Industry – Part II
Checkout Part 1 of this Blog: The Industrial Internet of Things and the Life Sciences Industry – Part I When discussing the Internet of Things (IoT),…
The Industrial Internet of Things and the Life Sciences Industry – Part I
Over the years, maintenance operations – as defined by standard plant accounting procedures – have been recognized as major expenses for manufacturing plants. Since 1981,…