controlc

Along with providing monitoring and validation systems, we frequently delve into issues that arise for our customers once they are interpreting regulations and guidance. We receive many questions on 21 CFR Part 11 and Annex 11. during this article, we provide some background and a quick overview of three focal points of both of the "Elevens" including System Controls, Validation and Archiving.   It's important to notice that Part 11 may be a requirement within the US, whereas Annex 11, which applies to the EU, may be a guidance document only. The "Elevens": Some Background   Computerized systems — crucial to pharmaceutical, medical device, and biotechnology manufacturing and distribution operations — differ from paper-based systems and manual systems traditionally used for creating and archiving records are getting rare.   This is (partly) why the FDA and EMA created 21 CFR Part 11 and Annex 11. But the important basis of "the elevens" is...

   Understand everything about the Learning Management System, the distance learning tool that has transformed the way knowledge is shared.   Technological advances have contributed to the development of several tools that facilitate the storage of information.   In the field of education, the LMS platform is one of those tools that has not only facilitated learning processes, but has transformed the way people learn and teach today.   Even so, many people who are facing the distance education market for the first time confuse the existing terms or do not know exactly what each one means.   So that there are no doubts about what the LMS platform is and what it offers to those who are interested in doing digital training, continue with us. We are going to talk all about it in this post!   What is the LMS platform? LMS is the acronym in English for Learning Management System , also known in Spanish as the Learning Management System...