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Showing posts from October, 2021

BASICS OF 21 CFR PART 11 COMPLIANCE

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Life science, biotech, pharmaceutical, and medical device companies are heavily regulated, and therefore the framework for the right management of digital records that would be submitted electronically during a regulatory FDA filing is 21 CFR Part 11, paralleled by Annex 11 within the EU.   As automation supported by sophisticated vision systems has become essential to the manufacturing of medicine and devices, Part 11 has become a subject of concern for quality managers worried that their processes might not be compliant.   Fortunately, ensuring compliance is easier and more straightforward than generally realized, supports all other compliance requirements, and provides for best practice record-keeping procedures generally . Any manufacturer with an automatic quality management system (QMS) that's Part 11 compliant will find that it generally enhances operations.   All that's required may be a little bit of extra attention to the precise requirements of mach...

Check out what LMS is and everything you need to know about it

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 It is not possible to define what LMS is without first addressing the changes brought about by technological advances. From social interactions, through education and reaching corporate environments, all spheres of society were impacted by this change.   The LMS system was born with this modernization. Based on the need to provide distance training to optimize time and resources, organizations ended up creating a great trend in communication and business training.   To help you better understand what this system is and how it works, we have prepared this post filled with relevant information so that you can implement this feature in your business. Read on and learn more!   What is LMS or Learning Management System? You may be wondering: what is LMS after all? The acronym comes from English, Learning Management System and is translated Learning Management System. Basically, it is an e-learning platform created from a pedagogical methodology that aims to...

Artificial Intelligence for Managers: Why Is It Important?

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  Far-sighted managers check out the benefits AI has for the longer term and adapt themselves accordingly. AI will help advance careers and produce faster business results, enabling good managers to become great at what they are doing . Given the big advantages AI has over citizenry , it's often sought to perform tasks earlier done by a person's with great precision and excellent results, regardless of the dimensions and sort of the info .   What makes AI Appealing?   AI can compress numbers, detect patterns, and make fast decisions driven by data with a precision that a person's might not do. Given the power to process large data sets and supply directions of trends and advice which will be acted upon, AI are often an important tool for any manager handling quantitative data to form decisions. The efficiency of computers is so good that it's estimated to exchange 40% of the human fund managers within the financial industry with robo-advisers.   Any good ...