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Video instructions and help with filling out and completing cfr marine
Welcome everyone to the first of many presentations that the computer system validation LCM team has focused on for this page today we'll be discussing 21 CFR part 11 regulations and how they pertain to us at Illumina consumables Manufacturing at a high level a very high level and yes that is a spaceship 21 CFR part 11 as defined by the FTA are regulations that set forth the criteria under which the agency considers electronic records electronic signatures and handwritten signatures executed to the electronic record to be trustworthy reliable and generally equivalent to paper records and handwritten signatures executed on paper part 11 regulations are similar to body 20 regulations body 20 as many of you would know are quality system regulations for medical device manufacturing regulations alumina has complied with in order to continue manufacturing medical devices by design part 11 regulations can be categorized into three key elements and those are electronic records electronic signatures and audit trails now let's dive a little deeper into each of these sub parts electronic records it's a combination of text graphics data pictures or audio represented in a digital format equivalent to a paper record that's created modified archived and retrieved by a computer system and I'm going to learn how to spell records immediately after this video electronic signatures can be defined as a combination of symbols representing the user name and password as a legally binding equivalent of an individual's handwritten signature as you can see here we're utilizing the combination of John Doe username and password as an electronic signature in an hour chronic bath record which is equivalent to John Doe signing off on a paper batch record now let's talk about Auto Trails the main purpose of Auto trails is to provide assurance with regards to the integrity of the electronic record various agency regulations as well as guidance documents provide us with the list of features that a computerized auto trail must have in order to be considered compliant the Artic trail must be attributable legible contemporaneous original and accurate auto trails can be retained either on the network or locally on the workstation PC Auto trails at a minimum must capture the following information identity of the user who perform the action type of action date and time of the action performed in further elaborating subpart B electronic records part 11 10 and 20 discuss the controls for closed and open systems with closed systems let's assume the stick figure is the owner responsible for the content of the electronic records that are on the system he or she will then control the access to authorized individuals open systems on the other hand are assistants where the access is not controlled by persons responsible for the content of electronic records that are on the system open systems aren't often used in the regulated industry as additional measures are required to implement authenticity integrity and confidentiality of data step up the electronic