What is the CFR 21 Part 11 standard and what are its requirements for a control system? I - The CFR 21 Part 11 standard was created in 1991 by mem...
What is the CFR 21 Part 11 standard and what are its requirements for a control system?
I - The CFR 21 Part 11 standard was created in 1991 by members of the pharmaceutical industry in conjunction with the Food and Drug Administration (FDA) to define criteria for electronic records and signatures.
II - According to the standard, a control system is considered safe if it includes user login, logout due to inactivity, and other procedures that ensure the authenticity of the user operating the system.
III - The standard also requires tracking and recording of data, as well as changes in the system.
IV - The implementation of the standard is done through methods and functions, regardless of the chosen supervisory system.
a) I, II, III and IV are correct.
b) Only I, II and III are correct.
c) Only II, III and IV are correct.
d) Only I, II and IV are correct.
I - The CFR 21 Part 11 standard was created in 1991 by members of the pharmaceutical industry in conjunction with the Food and Drug Administration (FDA) to define criteria for electronic records and signatures.
II - According to the standard, a control system is considered safe if it includes user login, logout due to inactivity, and other procedures that ensure the authenticity of the user operating the system.
III - The standard also requires tracking and recording of data, as well as changes in the system.
IV - The implementation of the standard is done through methods and functions, regardless of the chosen supervisory system.
a) I, II, III and IV are correct.
b) Only I, II and III are correct.
c) Only II, III and IV are correct.
d) Only I, II and IV are correct.
💡 1 Resposta
Ed 
O CFR 21 Parte 11 é um padrão criado em 1991 pela indústria farmacêutica em conjunto com a Food and Drug Administration (FDA) para definir critérios para registros e assinaturas eletrônicas. De acordo com o padrão, um sistema de controle é considerado seguro se incluir login do usuário, logout por inatividade e outros procedimentos que garantam a autenticidade do usuário que opera o sistema. O padrão também exige o rastreamento e registro de dados, bem como alterações no sistema. A implementação do padrão é feita por meio de métodos e funções, independentemente do sistema supervisor escolhido. Portanto, a alternativa correta é a letra "a) I, II, III e IV estão corretas".
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