MantisBT to be conform to FDA's "Part 11"?
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MantisBT to be conform to FDA's "Part 11"?
Hello community,
the company I am working for needs an 'Issue Tracker' for a new project, where we develop software for medical devices. So we need to be conform with the specifications the FDA requires.
We also want a Open-Source-Software. With all the requirements we (and the FDA) have, MantisBT seems to be one of the candidates who fits most. But there is only one problem: To satisfy the requirements of electronical signatures, we of course have to fulfill the '21 CFR Part 11'.
In this audittrails are required, which is in my eyes, fulfilled with Mantis' 'History' for each bug, isn't it?
But a second requirement gives me headaches... Part 11 says at §11.200(a)(1)(i) "... subsequent signings shall be executed using (the password)...". How can we handle this with MantisBT? Is there a plugin or configuration I didn't detected? Or do we have to code so with every submit the password is checked?
I really hope anyone can help So I don't think i am the first guy with this problem Thanks to all for reading and replying and have a nice day
the company I am working for needs an 'Issue Tracker' for a new project, where we develop software for medical devices. So we need to be conform with the specifications the FDA requires.
We also want a Open-Source-Software. With all the requirements we (and the FDA) have, MantisBT seems to be one of the candidates who fits most. But there is only one problem: To satisfy the requirements of electronical signatures, we of course have to fulfill the '21 CFR Part 11'.
In this audittrails are required, which is in my eyes, fulfilled with Mantis' 'History' for each bug, isn't it?
But a second requirement gives me headaches... Part 11 says at §11.200(a)(1)(i) "... subsequent signings shall be executed using (the password)...". How can we handle this with MantisBT? Is there a plugin or configuration I didn't detected? Or do we have to code so with every submit the password is checked?
I really hope anyone can help So I don't think i am the first guy with this problem Thanks to all for reading and replying and have a nice day
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- Posts: 2
- Joined: 10 May 2017, 12:07
Re: MantisBT to be conform to FDA's "Part 11"?
So my boss gave me a timeslot to contribute to program this feature in an Open-Source-Project. But I have a few questions to decide which one we will take, hoping anyone can give me an answer
- How big is the chance this feature (password requesting for every submit after changing anything in a ticket) will be adopted in the Mantis-Project?
- If there is a high chance, how long will it take?
- Would this change be complicated in Mantis?
Thanks for reading =)
- How big is the chance this feature (password requesting for every submit after changing anything in a ticket) will be adopted in the Mantis-Project?
- If there is a high chance, how long will it take?
- Would this change be complicated in Mantis?
Thanks for reading =)
Re: MantisBT to be conform to FDA's "Part 11"?
The best way to implement such a functionality is to write a plugin
https://www.mantisbt.org/docs/master/en ... ev.plugins
https://www.mantisbt.org/docs/master/en ... ev.plugins
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- Posts: 113
- Joined: 05 Jun 2019, 00:17
Re: MantisBT to be conform to FDA's "Part 11"?
any updates?
That would be good if anyone here may create such features to meet FDA's requirement. The MANTISBT may be introduced in pharmaceutical fields without any doubts.
That would be good if anyone here may create such features to meet FDA's requirement. The MANTISBT may be introduced in pharmaceutical fields without any doubts.
Re: MantisBT to be conform to FDA's "Part 11"?
seems to be the same request as made by "frankone".
In that topic I indicated that aplugin does not seem to be a very big task and I would look into it.
What it boilds down to, as far as i understood, is that when pressing the submit button with a new ticket or pressing the update button for an existing button, the user processing the ticket should provide password again. Only after successfull validation, database can be updated.
Is this the full picture?
In that topic I indicated that aplugin does not seem to be a very big task and I would look into it.
What it boilds down to, as far as i understood, is that when pressing the submit button with a new ticket or pressing the update button for an existing button, the user processing the ticket should provide password again. Only after successfull validation, database can be updated.
Is this the full picture?
Re: MantisBT to be conform to FDA's "Part 11"?
here is your FDA plugin,please follow the instructions
Feedback appreciated
Feedback appreciated
- Attachments
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- FDA200.ZIP
- (2.48 KiB) Downloaded 353 times
Re: MantisBT to be conform to FDA's "Part 11"?
Yes you described exactly what was needed.
I will download, test, and report the results!!
Thank you so much for your assistance in helping me find a solution
I will download, test, and report the results!!
Thank you so much for your assistance in helping me find a solution
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- Posts: 113
- Joined: 05 Jun 2019, 00:17
Re: MantisBT to be conform to FDA's "Part 11"?
Check password once again upon submitting/updating a ticket
no response when add new ticket
plugin installed:
BBCodePlus
Snippets
..
no response when add new ticket
plugin installed:
BBCodePlus
Snippets
..
Re: MantisBT to be conform to FDA's "Part 11"?
@amphetamine,
did you follow the instructions for installing?
Did you place the events @ the right place?
Which version of Mantis/OS are you using?
did you follow the instructions for installing?
Did you place the events @ the right place?
Which version of Mantis/OS are you using?
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- Posts: 113
- Joined: 05 Jun 2019, 00:17
Re: MantisBT to be conform to FDA's "Part 11"?
@cas
1. in bug_update_page.php, there are 2 places have the same code,
fixed issue
--
2. bug_report_page.php
there are two "*required" on bottom right corner
1. in bug_update_page.php, there are 2 places have the same code,
Code: Select all
<input <?php helper_get_tab_index(); ?>
type="submit" class="btn btn-primary btn-white btn-round"
value="<?php echo lang_get( 'update_information_button' ); ?>" />
--
2. bug_report_page.php
there are two "*required" on bottom right corner
Last edited by amphetamine on 12 Aug 2019, 13:34, edited 1 time in total.
Re: MantisBT to be conform to FDA's "Part 11"?
I need to check this later tonight and provide better instructions
On my installation it is working fine.
On my installation it is working fine.
Re: MantisBT to be conform to FDA's "Part 11"?
Here is a small update on the FDA plugin:
Adjusted the documentation:
now reflects the 2 positions which require adjustment in bug_update_page.php
Fixed some minor bugs ( double red asterisk and line break )
Thanks to Amphetamine for testing and reporting.
Now also included the 4 source files for mantis 2.21 ( to be found in doc\mantis2.21)
Hopefully fixed all bugs now
Adjusted the documentation:
now reflects the 2 positions which require adjustment in bug_update_page.php
Fixed some minor bugs ( double red asterisk and line break )
Thanks to Amphetamine for testing and reporting.
Now also included the 4 source files for mantis 2.21 ( to be found in doc\mantis2.21)
Hopefully fixed all bugs now
- Attachments
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- FDA201.ZIP
- (22.38 KiB) Downloaded 339 times
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Re: MantisBT to be conform to FDA's "Part 11"?
is it possible to remove password cookies when submit the issue?
Re: MantisBT to be conform to FDA's "Part 11"?
Unfortunately i did not update pages/check1.php in the distribution.
I will prepare a new one.
For now, you can remove the following lines form check1.php:
I will prepare a new one.
For now, you can remove the following lines form check1.php:
Code: Select all
<div class="widget-toolbox padding-8 clearfix">
<span class="required pull-right"> * <?php echo lang_get( 'required' ) ?></span>
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- Posts: 113
- Joined: 05 Jun 2019, 00:17
Re: MantisBT to be conform to FDA's "Part 11"?
@cas
Thank you!
Thank you!