September 25, 2007
I Like Your Mousetrap, Really!
I’ve reflected on more than one occasion that independent consulting is a strange business. We’re neither vendor nor customer, although obviously, it’s in our best interest to be very friendly with both. It is, therefore, really problematic when an independent consultant gives opinions like “I wish customers acted like this,” or, “I wish vendors built things this way,” since the risk is that no matter what is said, it might be...
Posted by Jeff Vannest at 08:58 PM | Comments (0) | TrackBack (0)
April 29, 2005
How to Care for Your New LIMS Consultant
Well, you've really gone and done it now, haven't you? You just had to have a new LIMS consultant. If you are a veteran of the LIMS consultant-owning scene, you surely can recall the excitement and enthusiasm you felt when you brought that first one into your office or quality unit. If this is your very first LIMS consultant, there may be just a bit of, "What have I done?" anxiety about this major moment in the life of your organization....
Posted by Jeff Vannest at 07:31 PM | Comments (0) | TrackBack (0)
March 18, 2005
Identifying Custom Code - Binary
Last week I presented a scenario wherein the correct version of custom code for a CFR Part 11 LIMS system had been lost, which presented the opportunity to review several methods of re-identifying custom code that was textual (meaning human readable). Let's now look for a way to reliably identify binary code in that same scenario.
Posted by Jeff Vannest at 09:05 PM | Comments (0) | TrackBack (0)
March 15, 2005
Identifying Custom Code - Textual
Eventually in the lifecycle of every project someone will look at a piece of custom software and think to themselves, "Is this the right version, or did I put the new version on my other computer?" While it seems silly for a company that likely spent thousands of dollars on analyzing, developing and validating that particular piece of software, this still happens in even with the best companies. Let's look at some ways a company can...
Posted by Jeff Vannest at 06:30 PM | Comments (0) | TrackBack (0)
February 28, 2005
Developers and Validation Professionals: Presentation
Last week we looked at ways that developers and validation professionals can communicate more effectively using targeted vocabulary. The next step is to present materials clearly and in ways that can be best understood by both parties.
Posted by Jeff Vannest at 08:38 AM | Comments (0) | TrackBack (0)
February 18, 2005
Developers and Validation Professionals: Communication
Developers are pragmatists and validation professionals are methodists. Developers excel when they think outside of the box and validation professionals are rewarded for precisely documenting the inside of the box. (It's like watching a train wreck in slow motion, isn't it?) The dichotomy is not as hard to unite as you might imagine, and requires only those concepts with which you're already familiar: communication and presentation.
Posted by Jeff Vannest at 04:25 PM | Comments (2) | TrackBack (0)
February 11, 2005
Controlling the Development Environment
LIMS professionals, even those IT managers that support LIMS departments, become hesitant when trying to control the development environment. It's like the feeling you get when you take your car in to be repaired. You're sure the guy behind the counter is going to spew mechanical mumbo-jumbo at you and end the barrage with a question.
Posted by Jeff Vannest at 04:20 PM | Comments (0) | TrackBack (0)
February 04, 2005
Controlling Code
Controlling custom code in a validated environment is a tricky endeavor. Between technical developers and managers and difficult software, it's often easier to overlook the problem than deal with it directly.
Posted by Jeff Vannest at 08:55 AM | Comments (2) | TrackBack (0)