Tag Archives: 21 CFR Part 11

AVEVA World 2022

Join us for the annual AVEVA World Conference in San Francisco! EIS has deep experience in implementing and supporting the AVEVA (OSIsoft) PI System, across a variety of industries. Visit us at Booth #56 to learn more about our PI Services and Solutions, including eDatasheet - Manual Data Entry and Logging to a PI System.

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GMP Software: How to Stay Compliant with 21 CFR Part 11

21 CFR Part 11: A Brief Overview of cGMP Manufacturing companies in the life sciences must follow FDA 21 CFR 11 and EU GMP Annex 11 requirements in order to sell products in the US and EU. As many organizations across the industry scale up production from clinical to commercial operations, adequate documentation and access […]

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What is Process Development in The Pharmaceutical Industry?

Process development is the process of creating new and improved production methods. It aims to optimize solutions to meet customer needs, maintain regulatory compliance, reduce costs and improve product quality. Process development in the pharmaceutical industry is a collaborative effort between operators, engineers, technicians, marketers, and production specialists. It involves designing processes, testing different scenarios, […]

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What is Advanced Manufacturing and What Does it Mean?

As the pharmaceutical industry continues to experience a great wave of growth, it is hard not to mention advanced manufacturing. As a result, advanced manufacturing has become a buzzword often used when discussing the future of factories, including pharmaceutical manufacturing. Combining its various elements aids effective pharma production while it brings flexibility. So stay glued […]

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How Do Electronic Logbooks Work in Pharmaceutical Manufacturing?

Electronic logbooks, eLogBooks, or e-logs in the pharmaceutical industry aren’t exactly new. Many manufacturers have been using software for years to track equipment, production, and manufacturing of raw materials and finished goods. eLogBooks reduce paper use by eliminating paper documents, improving visibility into production processes, automating data collection with manual data entry, implementing risk management […]

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The Biggest Trends in Pharmaceutical Manufacturing

The Biggest Trends in Pharmaceutical Manufacturing The pharmaceutical industry has undergone several changes which are often introduced and enforced by regulatory bodies. These changes, which we can also call a revolution, make up Pharma 4.0. Earlier in the day, pharmaceutical operations were manual and required solely the use of paper.However, as technology improved, pharmaceutical manufacturing […]

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Agility in New Areas of Life Sciences and Pharmaceutical Manufacturing

Agility in New Areas of Life Sciences and Pharmaceutical Manufacturing Pharmaceutical manufacturing has traditionally relied on centralized facilities for mass pharmaceutical production and distribution. As good as this method is, it may be limited when looking at the larger industry trends. This method guarantees product quality and consistency, but its rigidity prevents new manufacturing methods […]

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The Importance of Data Integrity in Pharma and Regulated Industries

Corrective and Preventive Action in Pharmaceutical Industry The use of data is an integral part of every system and sector. One core sector where data is so highly valued is the pharmaceutical industry. Not alone does this industry use data, it also places a premium on data integrity.In this blog post, we will analyze what […]

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How to Improve Manufacturing Operations with Review by Exception

How to Improve Manufacturing Operations with Review by Exception As the pharmaceutical industry grows ever more competitive, operations are continuously looking for ways to reduce overhead and production costs- without compromising quality and safety. Quality assurance (QA) plays a key role in ensuring that only products which meet acceptable criteria are produced and measures are […]

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