Tag Archives: 21 CFR Part 11

The Importance of Data Integrity in Pharma and Regulated Industries

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 data integrity is and its importance. […]

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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 taken to ensure proper documentation. Such a system requires […]

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Why Paperless Processes Are the Future of Work

Think of traditional working environments and one of the things that comes to mind is often desks, shelves and vaults stacked with pieces of paper. Some of it scribbled notes, some of it key performance data. All of it in some semblance of organization, but nothing readily available without some kind of search. Imagine a modern-day working […]

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Digital Equipment Use Logs: The Best Way To Track and Manage Your Equipment

Why Are Equipment Use Logs Important? Equipment documentation is fundamental to successful operations. In pharmaceutical and life sciences production, accurate equipment use logs are vital for equipment life-cycle management and compliance. A thorough equipment maintenance log must effectively manage the use of equipment throughout its life-cycle. Paper and pen have been the traditional means of […]

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OpsTrakker Mobile App Provides Significant Improvement to Manufacturing Operations

Enhanced Information Solutions (EIS) Inc. today released the results of a study that analyzes the realized business benefits of an equipment logbook mobile solution for a major biotech company. This solution, as one module in OpsTrakker, went live in production in early 2015 to provide equipment use log functionality for over 20 equipment classes and replace […]

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