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What’s the Difference? FDA 21 CFR Part 11 vs EU Annex 11

March 20, 2023

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, and differences between Part 11 […]

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Industry concept of GMP Good Manufacturing Practice.

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,…

Work Execution in a Paperless Environment

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: PQ, IQ, OQ

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…

FDA Form 483 Observations and Warning Letters

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…

compounding pharmacies compliance

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

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…

industrial iot

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),…

internet of things

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,…

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