# 21 CFR Part 11 Implementation

**URL:** <https://forum.inductiveautomation.com/t/21-cfr-part-11-implementation/98290>\
**Category:** Ignition\
**Tags:** vision, perspective\
**Created:** [November 6, 2024, 4:47pm UTC](https://forum.inductiveautomation.com/t/21-cfr-part-11-implementation/98290 "2024-11-06T16:47:50Z")\
**Posts on this page:** 2\
**Page:** 1

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**Author:** ![William\_R](https://sea1.discourse-cdn.com/inductiveautomation/user_avatar/forum.inductiveautomation.com/william_r/32/32710_2.png) [@William\_R](https://forum.inductiveautomation.com/u/William_R)\
**Post date:** [November 6, 2024, 4:47pm UTC](https://forum.inductiveautomation.com/t/21-cfr-part-11-implementation/98290/1 "2024-11-06T16:47:50Z")

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Hello Everyone,

I have a very general question that I hope I can get some insight into. Say you have a Vision project (could relate also to Perspective) that is fully developed as an assembly machine. You have a database already configured for collecting machine/part data (all done through gateway/project scripting) and you have 4 basic roles for login credentials and accessibility (no Active Directory created). How big of a task would it be to add 21 CFR Part 11 functionality into this project. This project would not contain any extra modules, just the base vision license. I only understand 21 CFR Part 11 at a cursorily level, but would have to implement this all myself. This would include learning the requirements, coding the functionality, and modifying already existing components of the project / database to meet all of the GxP requirements. I know this question is very broad, but any insight could be very informative for me.

TIA.  
William

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**Author:** ![Kevin.Herron](https://sea1.discourse-cdn.com/inductiveautomation/user_avatar/forum.inductiveautomation.com/kevin.herron/32/7259_2.png) [@Kevin.Herron](https://forum.inductiveautomation.com/u/Kevin.Herron)\
**Post date:** [November 6, 2024, 4:54pm UTC](https://forum.inductiveautomation.com/t/21-cfr-part-11-implementation/98290/2 "2024-11-06T16:54:03Z")

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These might be useful in your quest:

- [21 CFR Part 11 Compliance with Inductive Automation’s Ignition Platform | Inductive Automation](https://inductiveautomation.com/resources/article/21-cfr-part-11-compliance-with-inductive-automations-ignition-platform)
- [21 CFR Part 11 and Pharmaceutical Best Practices with Ignition | Inductive Automation](https://inductiveautomation.com/resources/article/21-cfr-part-11-and-pharmaceutical-best-practices-with-ignition)