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How Alarm Notification Systems Ensure GMP Compliance in Manufacturing

This article was originally published on AutomationWorld.com on July 15, 2024.

For companies in regulated industries, such as life sciences, properly managed alarm notification systems are key to quality assurance.

Life science companies must adhere to the FDA’s Good Manufacturing Practices (GMP) in manufacturing and storage of the product within their manufacturing facility. For example, GMP compliance is required for a bioreactor process and for any product storage in a freezer room. GMP ensures that each step of the manufacturing process is conducted under controlled conditions, with appropriate documentation, data records and quality checks at each stage. Read More

21 CFR Part 11 and Pharmaceutical Best Practices with Ignition by Inductive Automation

In an era where the manufacturing industry is rapidly shifting towards digitalization, it is crucial to stay updated on the latest technologies and compliance requirements that can drive this digital transformation. Manufacturers in the life sciences and pharmaceutical industries regularly use Ignition by Inductive Automation in applications requiring 21 CFR Part 11 given the company’s commitment to enabling customer success with regulated applications. Read More

Using Your Building Management System as Your Environmental Monitoring System

Why you shouldn’t use your Building Management System as your Environmental Monitoring System

You might be wondering, since I already have a Building Management System (BMS), why can’t we just use that for an Environmental Monitoring System (EMS) as well? While it may seem like a convenient option at first glance, a deeper look at the capabilities of each system reveals that relying solely on a BMS for comprehensive monitoring and compliance might not be the wisest choice. Read More

Are you prepared? Introducing OT SafetyNet: Your Ultimate OT Asset Discovery & Recovery Solution

OT Asset Inventory Imagine a scenario where a devastating flood engulfs all the Industrial Control System (ICS) equipment that powers your machinery and orchestrates your processes. PLCs, drives, HMI/SCADA systems, recipes, MES configurations, historical data—all lost to the flood. As the waters recede, a daunting question emerges: How long will it take to recover your manufacturing operations, if recovery is even possible? This somber picture underscores the vital significance of having a service like OT SafetyNet that not only provides an OT asset inventory and discovery tool, but also a disaster recovery strategy, making the difference between a momentary setback and an insurmountable halt. Read More

Unlocking the Power of Data: Digital Transformation in Life Sciences

digital transformation in life sciencesIndustry 4.0 is marching towards digital transformation in life sciences and smart factories are being driven by IIoT, real-time data, cloud computing, and machine learning. With its implementation comes the promise of increased efficiencies and improved processes. The idea sounds simple, but manufacturing has many distinct data points across its entire process and integrating a digital transformation strategy and data across an enterprise is a far more challenging undertaking, especially in regulated environments. Read More

NeoMatrix Retrofits OEM Skids with ISA-88 and FactoryTalk Batch

FactoryTalk BatchNeoMatrix utilized Allen-Bradley programmable automation controllers (PACs) and Rockwell Automation’s FactoryTalk® Batch system to provide flexible, efficient solution.

A leading U.S. pharmaceutical company with offices throughout the United States and 17 other countries, the company wanted to expand its capabilities in its purification suite from “islands of automation” to a distributed control system. Read More

Ignition Software Helps Snapdragon Chemistry with 21 CFR Part 11

Ignition Software Provides FDA Compliance for Pharma, Along with Speed and Flexibility

Case Study Originally Written and Published by Inductive Automation

Snapdragon 21 CFR Part 11 Pharma ComplianceSnapdragon Chemistry is a leader in developing continuous-flow chemistry solutions for the discovery and production of active pharmaceutical ingredients, intermediates, and materials. The company is based just outside Boston, and its customers discover and manufacture pharmaceuticals, animal care products, materials, and other fine chemicals. Read More