MantisBT to be conform to FDA's "Part 11"?

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aequatio42
Posts: 2
Joined: May 10, 2017 7:07 am

MantisBT to be conform to FDA's "Part 11"?

Post by aequatio42 » May 10, 2017 7:22 am

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 :)

aequatio42
Posts: 2
Joined: May 10, 2017 7:07 am

Re: MantisBT to be conform to FDA's "Part 11"?

Post by aequatio42 » May 11, 2017 10:36 am

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 =)

atrol
Site Admin
Posts: 7658
Joined: Mar 26, 2008 4:37 pm
Location: Germany

Re: MantisBT to be conform to FDA's "Part 11"?

Post by atrol » May 12, 2017 4:15 am

The best way to implement such a functionality is to write a plugin
https://www.mantisbt.org/docs/master/en ... ev.plugins
Please use Search before posting and read the Manual

amphetamine
Posts: 34
Joined: Jun 04, 2019 7:17 pm

Re: MantisBT to be conform to FDA's "Part 11"?

Post by amphetamine » Aug 04, 2019 4:04 am

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.

cas
Posts: 600
Joined: Mar 11, 2006 11:08 am
Contact:

Re: MantisBT to be conform to FDA's "Part 11"?

Post by cas » Aug 04, 2019 10:52 am

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?

cas
Posts: 600
Joined: Mar 11, 2006 11:08 am
Contact:

Re: MantisBT to be conform to FDA's "Part 11"?

Post by cas » Aug 10, 2019 11:27 am

here is your FDA plugin,please follow the instructions :)
Feedback appreciated :mrgreen:
Attachments
FDA200.ZIP
(2.48 KiB) Downloaded 4 times

FrankOne
Posts: 5
Joined: Jul 02, 2019 12:03 am

Re: MantisBT to be conform to FDA's "Part 11"?

Post by FrankOne » Aug 10, 2019 5:07 pm

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 :D

amphetamine
Posts: 34
Joined: Jun 04, 2019 7:17 pm

Re: MantisBT to be conform to FDA's "Part 11"?

Post by amphetamine » Aug 10, 2019 8:54 pm

Check password once again upon submitting/updating a ticket

no response when add new ticket :wink:

plugin installed:
BBCodePlus
Snippets
..

cas
Posts: 600
Joined: Mar 11, 2006 11:08 am
Contact:

Re: MantisBT to be conform to FDA's "Part 11"?

Post by cas » Aug 11, 2019 8:53 am

@amphetamine,
did you follow the instructions for installing?
Did you place the events @ the right place?
Which version of Mantis/OS are you using?

amphetamine
Posts: 34
Joined: Jun 04, 2019 7:17 pm

Re: MantisBT to be conform to FDA's "Part 11"?

Post by amphetamine » Aug 11, 2019 7:46 pm

@cas
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' ); ?>" />
fixed issue
--

2. bug_report_page.php
there are two "*required" on bottom right corner
Last edited by amphetamine on Aug 12, 2019 8:34 am, edited 1 time in total.

cas
Posts: 600
Joined: Mar 11, 2006 11:08 am
Contact:

Re: MantisBT to be conform to FDA's "Part 11"?

Post by cas » Aug 12, 2019 3:08 am

I need to check this later tonight and provide better instructions :mrgreen:
On my installation it is working fine.

cas
Posts: 600
Joined: Mar 11, 2006 11:08 am
Contact:

Re: MantisBT to be conform to FDA's "Part 11"?

Post by cas » Aug 12, 2019 12:20 pm

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 :mrgreen:
Attachments
FDA201.ZIP
(22.38 KiB) Downloaded 3 times

amphetamine
Posts: 34
Joined: Jun 04, 2019 7:17 pm

Re: MantisBT to be conform to FDA's "Part 11"?

Post by amphetamine » Aug 12, 2019 7:32 pm

bug.png
bug.png (14.37 KiB) Viewed 112 times
still there as shown on attached picture.

is it possible to remove password cookies when submit the issue?

cas
Posts: 600
Joined: Mar 11, 2006 11:08 am
Contact:

Re: MantisBT to be conform to FDA's "Part 11"?

Post by cas » Aug 13, 2019 2:02 am

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:

Code: Select all

<div class="widget-toolbox padding-8 clearfix">
<span class="required pull-right"> * <?php echo lang_get( 'required' ) ?></span>

amphetamine
Posts: 34
Joined: Jun 04, 2019 7:17 pm

Re: MantisBT to be conform to FDA's "Part 11"?

Post by amphetamine » Aug 13, 2019 3:07 am

@cas
Thank you! :D

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