21 CFR part 11 validation for SAAS - validation

In a FDA regulated environment applications need to be validated. I've done that tons of times in my career but now I'm facing SAAS. Has anyone out there faced this before? Any FDA related guideline on this scheme?
Besides some black box approach and much support from the provider I see this as hard to do.

I hear ya!
It is impossible...
check out: http://www.vantagesystems.com/Library/Pharmaceutical%20Commerce_Article_%20IMPROVING%20ERP%20IN%20THE%20LIFE%20SCIENCES%20INDUSTRY.pdf
Since original link is dead, here's a wayback machine archive link for the same article
https://web.archive.org/web/20100601233736/http://www.vantagesystems.com/Library/Pharmaceutical%20Commerce_Article_%20IMPROVING%20ERP%20IN%20THE%20LIFE%20SCIENCES%20INDUSTRY.pdf

It is indeed possible to run a validated SaaS for medical devices.
In fact here is QPharma's perspective on this.
Note I am not affiliated with QPharma, but I am very much interested in SaaS and validation techniques. The point is it is indeed quite possible!

Related

Janusys.com or Janusus.net Website and Forum

is there anybody who preserved the old Website of the Janusys company. Mostly known for their GridEX Winforms control but they had a complete suite of Winform Tools. Their support was (up until 'bankruptcy') very good and gave much more info on how to use their control in a non standard way.
I still use their components a lot in my projects and up until last year there was still a lookup method on http://janusys.net to get ideas if I was stuck.
The site(s) are out of the air now, so I hope someone has made a 'copy'??
regards Sandor
I hope too.
I hope the site is reactivated or that someone has managed to make a backup

Is there a simple Bugzilla/Trac client for use by non software folks?

I'm aware this isn't exactly a programming question, but it directly impacts our developers and the code we're assigned to write. If there's another SO-like forum where this could be better posted, please let me know and I'll take the question down from here & post it there.
Our work environment is a couple of developers creating (20-30%) and maintaining (lion's share) legacy software for factory production floor and test workers to use to calibrate or test the equipment the company sells. We've implemented a very simple Google form based bug reporting page, but we're already running into problems of scale (approx 40:1 them:us and lots of old-old buggy software that we didn't write). The company has tried using Bugzilla before my arrival with little success, the factory folks were apparently intimidated by it and wouldn't use it. However, they seem to like the simple Google form and the wizard-like steps to file a bug or request a feature. We're currently manually cutting & pasting their bug/feature requests from the Google form spreadsheet into Trac, and manually tracking the bugs/feature requests on a white board with magnetic bug cards. We're only a few weeks into this system and it's already showing it fragility and lack of scalability.
Ideally we'd have a Windows >= XP web or desktop client that would provide:
Simplified bug reporting, a Wizard like approach seems to work well
Customizable for our software packages (like drop downs for each)
Bugzilla or Trac integration
Standard bug tracking features developers and management can use
I've found the winners of the "Make Bugzilla Pretty" contest, but coming from a pure software house where we just used straight Bugzilla out of the box, I'm unclear on how to configure and install these skins. Obviously I can figure this out but don't want to go down that path if it's not going to solve our basic problem which is non-technical people reporting bugs.
TaskCompiler, found on the Bugzilla wiki site seemed like a candidate because it talks to both Bugzilla & Trac, but their sales page is offline and the site hasn't been updated since 2012 and I'm unsure as to their viability.
I'm certain we're not the first production facility to run into problems like this, I'm looking for recommendations to help solve both our scalability as well as-ease-of-use problem.
Another thought that occurs to me is a GAS script to push our current Google forms based bug reports into Trac or Bugzilla.
Edit: The decision between Bugzilla/Trac seems to have been made for us. I'm exploring options for using Trac here if you want to follow along.

Regression testing on Apple WebObjetcs GUI

I have recently started a new job in a company that depends heavily in an application developed with Apple Web Objects.
It happens that this company does not have a way to make automated tests whenever a new update is received, weather with bug fixes or new features.
We have no access to the code since it is a proprietary application.
My idea is to develop a suite of test cases to allow us to do regression testing through the GUI.
I have looked for tools for this, but could not find anything capable of "seeing" which components are in the GUI.
Before I arrived to the company, other people had already tried with HP LoadRunner with no success. I tried with AutoIt 3.0 just to check if it would recognize the fields, but also without success.
Anyone with experience testing such kind of application?
Which tools do you think that could fit for this purpose?
I appreciate your opinion.
Thank you!
Bruno
After some research I found a few good solutions for such problem. I came down to two solutions. Both of them are image based "which means it can "see" the user interface, just as the human eye does".
Proprietary solution
http://www.testplant.com/
Open source solution
httpp://groups.csail.mit.edu/uid/sikuli
Hope this can help others in the future.

A good framework for easily creating a social networking site

I was just reading about Magento, a free framework for easily creating an ecommerce site. I was wondering if anyone knew of a similar, easy to use framework that is designed specifically for social networking sites.
Thanks in advance for your wisdom!
I've seen a few people mention MonoX (based on ASP.Net), but I've not had a chance to evaluate it yet myself: http://www.mono-software.com/Pages/MonoX-ASP.NET-Portal-Framework.aspx
Ning.
Edit. The Ning business model is, they host your community for free and they get the revenue from adverts on the site. If you want to host it yourself you can, but you need to license the software.
Edit 2 I recommended Ning because I participate in a community hosted there. A minute's Googling through Elgg which seems to be more what you're looking for, but I haven't had an direct experience of it.
Laconi.ca (micro-blogging - which could be considered a subset of social networking). It's an open source option on which you could base a project (plugins have already been developed).
You could try something like JomSocial, which is built on top of Joomla.
Having just looked at this question again, you might find that Drupal is pretty useful in building a social networking site too.
We have recently built a private social network for a client, based on Drupal, and lots of the functionality is a pretty good match, particularly if you include modules such as User Relationships and Organic Groups.
I hope that helps!

Is there a good Fogbugz client for Mac OS X?

And/or: do I need one?
I've recently started using FogBugz for my hobby projects, and I'm very happy with things so far. Having read more about it, especially the evidence-based scheduling, I'd like to start using it for my PhD as well. (Heh; something tells me my supervisors won't be opening tickets for me, though.)
Last night I stumbled onto TimePost, which looks like a tidy app that doesn't do much but could be a real bonus to logging my time in FogBugz effectively. I tried looking around for similar apps but came up a little empty-handed. Are there any other FogBugz clients that you've used and recommend for Mac OS X? Or are you happy with the web interface?
The official answer is no, there is not a dedicated Mac client, other than Safari :)
There's a command line version that runs on Linux, Windows, and Mac.
There are also plans for an iPhone version although I'm not technically supposed to announce features before they are done or even spec'd so pretend I didn't say that.
I recently spotted this one which looks quite nice for additions:
http://manicwave.com/products/tickets
I'm happy with using the web interface. I've used Fluid to create a custom browser for it, and even gotten some help making a pretty icon.
We recently released a new Fogbugz client software for Mac, maybe you are interested to give it a try, http://lithoglyph.com/ladybugz/
I remember reading that there was a client in development, and I believe they're still looking for beta testers. See this URL
http://support.fogcreek.com/default.asp?fogbugz.4.24403.0
Shameless plug here, but you might wanna check out QuickBugz --- it is a lightweight program that integrates into your status menu. http://www.quickbugzapp.com
I have been very happily using the Tickets program from Manic Wave for a few weeks now. it provides a very fluid experience. I am using it in a pressure cooker of doing a competition entry in my odd hours around my day job.
Tickets makes it incredibly easy to create lots of small cases and juggle them between different milestones. I particularly like its outline view which helps when doing task breakdowns into sub-tasks.
Being a long way from the Fogbugz servers, in Western Australia, the speed of a searchable local interface is very much appreciated.
The UI has a lot of nice little Macisms such as mouse over a milestone and see the hours summarized.
Support has also been very prompt and comprehensive.
I don't think there is any other such Mac tool. I've never found the web interface too bad personally.
I don't know of any native tool, but like Matt I am pretty happy with the web interface.
The beta of Safari 4 and SSB feature is a pretty good option...
I found using a Mac browser w/ the screen snapshot and search engine add-on to be very useful. I think what you are saying is that it can be hard to edit your timesheets, but that is part of the web design.
I've just released Bee, which is a Mac client for FogBugz. (It also pulls in your tasks from GitHub and JIRA.)
It offers several benefits over the web interface and is designed to be simple, fast and elegant. You can check it out at: http://www.neat.io/bee/fogbugz.html

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