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21 CFR part 11 compliance: What do you need to know before incorporating an LMS in your business?

Although the title of the regulations sounds cryptic and too complicated, it is actually quite simple. 21 CFR Part 11 is actually an abbreviation for Part 11 of Title 21 of the Code of Federal Regulation. Which is the regulatory law for electronic signatures and documentation in the Foods And Drugs department more commonly known as the FDA. But what does that have to do with a learning management system

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21 CFR part 11 compliance: What do you need to know before incorporating an LMS in your business?

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  1. 21 CFR PART 11COMPLIANCE: What do you need to know before incorpora�ng an LMS in yourbusiness?

  2. 21 CFR PART 11COMPLIANCE: WHAT DO YOU NEED TO KNOWBEFORE INCORPORATING AN LMS IN YOURBUSINESS? Although having a learning management system for your business sounds like a very good idea and may be able to provide reforms amongst your employees. But what is the most important purpose of incorpora�ng an LMS system into your business? Is it to increase sales? Or to increase produc�vity? No. The most major purpose of an LMS system in a business is to make sure that your employees are compliant with the rules and regula�ons set by the industry that your organiza�on needs to follow. 21 CFR complianceisoneoftheseregula�ons,butwhatexactlyisit?

  3. 21 CFRCOMPLIANCE Although the �tle of the regula�ons sounds cryp�c and too complicated, it is actually quite simple. 21 CFR Part 11 is actually an abbrevia�on for Part 11 of Title 21 of the Code of Federal Regula�on. Which is the regulatory law for electronic signatures and documenta�on in the Foods And Drugs department more commonly known as the FDA. Butwhatdoesthathavetodowithalearningmanagementsystem? Since in the business industry, all life science and clinical related industries are to follow the FDA regula�ons, your LMS system is also under the flag of the FDA. This is only in place to make sure that the training content, that may include cri�cal informa�on regarding the organiza�on is protected from all physical harms and is not disclosed to any unauthorizedpar�es.

  4. WHAT DO YOU NEED TO KNOWTO MAKE SURE YOUR LMS IS 21 CFR PART 11COMPLIANT? Restricted dataaccess Your LMS needs to have well-defined access authen�ca�ons that dictate the level of informa�on a certain person at a certain level of the hierarchy is able to view. This not only helps you keep the security of your business content but also makes sure that you don’t overload your employees with unnecessary informa�on.

  5. Useraccess Strict protocols are to be put in place to make sure that no unauthorized individual is able to access the informa�on present on the learning management system. Making the content of the training courses easily accessible to authorized personnel yet at the same �me maintaining the security of theinforma�on.

  6. E-Signatures This is where the regula�on truly takes effect. An E-signatures are an assortment of numbers, alphabets, and symbols authorized to represent an individual. Every single individual,regardless of having the same hierarchical level, has the different E-signatures, hence, it is responsibility of the LMS toverify the signature before allowing access to thecontent.

  7. Audit andtracking Just like an offline system, there needs to be a proper and intrinsic record of all the changes that are being made in the content of the LMS to ensure an audit trail and to find the person responsible for the changes with relevance to theirE-Signatures.

  8. UpdateTracking With the pace at which the world is progressing, informa�on becomes obsolete in the blink of an eye. As soon as a new program is introduced or a new so�ware has been implemented, everything you have known to that point becomes obsolete. This is why it is crucial for your system to constantly check for any relevant updates that may be required and keep track of all previously madeupdates.

  9. Repor�ng The repor�ng authority of all LMS systems under the 21 CFR part 11 compliance is s�ll the FDA and they can demand an updated report at any moment’s no�ce. Make sure that all informa�on and records are always maintained to the most recent changes and that your system is ready to generate a proper and complete report, whenever it is demanded of it. Well there you have it, this is what your LMS needs to have to make sure that it is compliant with the 21 CFR part 11 compliance. Is your LMS up to par? Or are you missing out on something and need to work on it? We hope that this informa�on was useful for you. Swing by our other blogs for more similar ar�cles regarding performance management and learningmanagement.

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