Ah sorry, I missed your bit about the CryptoPlugin.  I am looking at it 
now....

On Friday, September 7, 2012 4:48:25 PM UTC-4, hasienda wrote:
>
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> On 07.09.2012 17:25, jules wrote: 
> > Hi folks, 
> > 
> > 
> > I was wondering if there was any group out there that has validated trac 
> > 
> > for use in a regulated environment? My company has been using trac for 
> the 
> > 
> > last few years for defect tracking workflow, but we're applying to be a 
> > 
> > class 1 medical device and have to validate all of our internal 
> software. 
> > 
> > Just wondering if anyone out there has done it or did they have to 
> migrate 
> > 
> > their ticketing system to something else. 
>
> Interesting questions. But bear in mind, that few of us may even know 
> details of terms like "class 1 medical device". To fill into this gap I 
> provide results of a quick research of mine [1][2]. I know, this is 
> partly advertising for that companies product(s), but don't mind since 
> I'm not at all affiliated with them. 
>
> Now that I've found some key requirements I can assure you, that you'll 
> probably meet most of them with Trac, if you have a suitable ticket 
> work-flow and restrictive user permissions setup. I'd even vote to go 
> for new horizons with known-good tools, that your staff is familiar with. 
>
> Your company may by an FDA verified toolbox at any time. But will your 
> critical business knowledge migrate into it automatically? We all know 
> the answer: Consultants. Don't get me wrong, Some may be pretty much 
> worth the money, but I hate doing the ground work, being told how to do 
> different, and finally taking responsibility and work to fix stuff 
> because of decisions I wasn't heard or even asked about. If you're 
> clueless, take that route, but if you know a bit, don't let them make 
> you look like a fool. /rant finished 
>
> The most critical part from my point of view is the digital signature 
> thing. I'm sorry, there's no native Trac solution for that right now, 
> but I suggest keeping an eye on CryptoPlugin [3]. (Disclosure: I'm the 
> author.) 
>
> This is currently WiP, but I've envisioned requirements like these 
> mentioned to be checked by FDA, so probably I'll address most of them, 
> later on. I'm testing wiki pages signed with strong crypto algorithms 
> (not published yet), and will extend this to attachments and tickets 
> too, as I progress. 
>
> Encryption is planned as well - think of restricted content, but not by 
> means of rather weak permission checks, that will disclose information, 
> if the plugin is deactivated or just dysfunctional[4], but using 
> industry grade crypto again. So in worst case you'll see just garbage, 
> but only using your OpenPGP key you'll be able to retrieve the content 
> after encryption. 
>
> I'd welcome detailed specs and requirements to be able to address them 
> as my time permits. Bear in mind, that I won't be able to do any 
> software validation other than adding unit tests to prove fitness for 
> the/your/any application. This would be left to you or to your companies 
> partners. 
>
> I put faith in Trac for my own Trac applications. If you already trust 
> in Trac, you could share my vision, and it may be worth to try making it 
> a TrustedTrac [5]. 
>
> Sincerely, 
>
> Steffen Hoffmann 
>
>
> [1] 
> http://www.arenasolutions.com/resources/articles/medical-device-development 
> [2] 
> http://www.arenasolutions.com/resources/articles/21cfrpart11-compliance 
> [3] http://trac-hacks.org/wiki/CryptoPlugin 
> [4] http://trac-hacks.org/ticket/5784 
> [5] http://trac.edgewall.org/wiki/TracDev/TrustedTrac 
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