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Antoine N

Antoine N

6 Software Validation Best Practices for Regulated Industries

Software validation, also called “computer system validation”, is a process that confirms a piece of software is designed for and satisfies its intended purpose. It involves reviews during software development or selection, and systematic installation procedures and testing during deployment....

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AS9100: A Guide to the Aerospace Industry’s Quality Management Standard

The AS9100 standard is a document that contains the requirements for implementing a quality management system (QMS) for companies operating in the aerospace industry (aviation, space, and defense). It is the prevalent standard used globally, and in general any companies doing business in this...

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10 Questions About Remote Monitoring, Answered

The rapid pace of technological change in recent years, particularly when it comes to the Internet of Things (IoT), has reshaped many industries — including environmental monitoring. Cloud-based, remote monitoring via internet-enabled data loggers and a central interface to track them all has...

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Temperature Mapping: A Critical Process for Maintaining Compliance

In regulated industries, we often encounter materials and processes that are highly sensitive to temperature and humidity. The storage of certain pharmaceuticals is one example. In these situations, temperature mapping, also referred to as thermal mapping, is a GxP method that is used to prevent...

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IQ OQ PQ: How to Navigate Essential Quality Assurance Processes

According to the FDA, “the term qualification refers to activities undertaken to demonstrate that utilities and equipment are suitable for their intended use and perform properly. These activities necessarily precede manufacturing products at the commercial scale.”

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Creating a HACCP Plan: What Your Organization Needs to Ensure Food Safety

Food safety is an underlying concern touching every corner of the food industry, from manufacturers and distributors to the consumers ultimately eating the food. Hazard Analysis and Critical Control Points (or HACCP) is an internationally-recognized method of identifying and managing the risks...

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Remote Monitoring: 4 Key Ways It Can Benefit Your Organization

The rapid pace of technological advancement in the past few years has resulted in the ascension of the Internet of Things (IoT), an online environment in which computers and objects can communicate via an internet connection. This seismic change has impacted many areas of modern life, from...

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Environmental Monitoring Best Practices: Maintain Compliance and Monitor Critical Conditions

Environmental monitoring refers to the process of collecting environmental data over time and monitoring for any changes that could be detrimental to the manufacturing or distribution of a product.

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An Essential Guide to GxP (Good Practices) for Heavily Regulated Industries

In many cases, individual consumers cannot verify the quality of products that can significantly affect their health and safety. Instead, they rely on manufacturers and distributors to follow a strict set of practices to consistently manufacture, store, and distribute high quality products.

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Thermal Mapping from A-Z

When it comes to producing and storing temperature-sensitive products, sometimes the long list of terms and information involved in mapping can get a little confusing. Below is a list of abbreviations and key terms to help make digesting your mapping report and validation easier.

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