How to achieve FDA 21CFR Part 11 compliance in Citect Scada
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2 سال پیش
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How to achieve FDA 21CFR
How to achieve FDA 21CFR Part 11 compliance in citect scada
This document is a guide to how to configure Vijeo Citect to meet each requirement of 21 CFR Part 11.
Part 11 (21 CFR Part 11) applies to any paper records required by statute or agency regulations and supersedes any existing paper record requirements by ...
you can configure VJC SCADA so as to it will comply most of the required features for 21CFR11 compliance uising the attached procedure.
CiTect for Pharm Application, was 21 CFR Part 11
highlights
1.Password Complexity.
2.User Access Permission
3.Audit trail required.
4.Non Editable Report
5.Only Authorized person can add, delete, Create
& Modified user account.
6.Each user should be change password after
defined days.
7.Alarm & Event Log Report.
8.No activity by user for certain time then auto Logout
9.Certain no of time wrong password enter then user account locked.
10.User should be change password after certain period of time
This document is a guide to how to configure Vijeo Citect to meet each requirement of 21 CFR Part 11.
Part 11 (21 CFR Part 11) applies to any paper records required by statute or agency regulations and supersedes any existing paper record requirements by ...
you can configure VJC SCADA so as to it will comply most of the required features for 21CFR11 compliance uising the attached procedure.
CiTect for Pharm Application, was 21 CFR Part 11
highlights
1.Password Complexity.
2.User Access Permission
3.Audit trail required.
4.Non Editable Report
5.Only Authorized person can add, delete, Create
& Modified user account.
6.Each user should be change password after
defined days.
7.Alarm & Event Log Report.
8.No activity by user for certain time then auto Logout
9.Certain no of time wrong password enter then user account locked.
10.User should be change password after certain period of time
2 سال پیش
در تاریخ 1401/08/17 منتشر شده
است.
297
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