What is 21 CFR PART 11 ?



hello friends Jimmy Murray Chalco person calcanei our felucca nacho theater please is subscribe button pick liquor a our job in my videos vananga or video scan notifications on achillea please the official paper on Kappa Jamaican tea hoagie you say please click a tacky opcode JP my videos bonaga cotton hitachi later 21 CFR lever actually it is called Title 21 CFR part 11 what is CFR it is code of federal regulation it is a codification of the general and permanent rules published in the Federal Register by the executive department and agencies of the federal government that title 21 of the CFR is reserved for rules of the Food and Drug Administration called FD a part leaven it is a part of title 21 CFR that establishes the United States FDA regulations on electronic records and electronic signatures part 11 it defines the criteria under which electronic records and electronic signatures are considered trustworthy reliable and equivalent to paper records records are kept for a number of reasons it happens only to those records that persons create modify maintain archive or transmit under any records or signature requirements set forth in the federal Food Drug and Cosmetic Act or any FDA regulations traditionally these records have been paper-based and stored in files or binders when those records required signatures the documents distributed to all parties on the Signet list and the signatures were stored along original the software developer should understand about part leaven cause the job of the software developer is to provide the organization with the tools it needs to meet the regulations electronic records must be maintained under described regulations to this file and FDA audit if a system is defined as closed then the following points of soft development should be considered first point sister accuracy reliability consistent intended performance and the ability to discern invalid or altered records second point record must be stored in such a way that they can be inspected viewed or copied by the FDA in both human readable and electronic form third point electronic records must be maintained for as long as the paper records that they replace next point secure computer-generated time-stamped audit trails must independently record operator activities that create modify or delete electronic records without obscuring previously recording systems that might span different time zones the agency advised that a time zone reference should be part of the timestamp vendor appear in human readable form of the time stamp next point sequencing of process steps our events must be enforced whenever possible next point only authorized individuals must be allowed to use the system sign a record or alter an existing record next point time sequence development and modification of all system documentation must be logged via an audit trail and the second condition if system is defined as open that is emailed records internet-based applications etcetera and are falling atom should be also be considered document encryption may be necessary to maintain confidential next point digital signature standards must or may be used to in short record authenticity and integrity signatures considerations the printed name of the signer the date and time the record was signed and the meaning of the signature must be captured as a part of any signature any electronic or handwritten signature record must be linked to its corresponding electronic record so that it can be copied electronic signature do not have to be based on biometric username and password can be used each combination of user name and password must be unique user name should not be reused passwords should expire periodically last point safeguard should be implemented to detect and port usernames and passwords they may have been compromised these requirements must be implemented by software developer and the organization must configure the applications train users made an emergency backup plan limit system access hold user accountable for electronic signatures thank you you

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