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The PAT toolkit™ Story
Challenge:
Eight years ago a validation client wanted to watch their manufacturing process as it occurred. They were
producing a product with an efficacy of 7 days, which made for some big challenges. Mountains of data
were being produced from a variety of instruments and the question was how to break it into manageable chunks,
analyze it, and use it to make powerful quality decisions in a real-time environment.
Solution:
No vendor was doing this particular kind of software in pharmaceutical manufacturing in 1998, which was four years before the FDA
put forth its Process Analytical Technology (PAT) Initiative. We set about building a platform from the ground up. The results?
Tabulating data is cut down from 3 days to 30 seconds. Hundreds of thousands of dollars are saved on an annual basis by seeing
problems before they happen. This hard-earned knowledge has proven to be an invaluable experience for our developers and has
given us a foundation of knowledge to provide innovative solutions for companies implementing the PAT initiative.
Today:
The PAT toolkit™ has been in use with some of the largest pharmaceutical manufacturers in the world and saves
our clients not only time and money but also a quite few headaches. That’s the best part of all.
Case Study: Tyco Healthcare in
their own words about PAT toolkit™.
Our Philosophy
The inspiration for such products as the PAT toolkit™ grew from our founders Lance Tinseth and Kelly Jordan
and their 13 years of work in the validation field. What started out as a company ran out of a small backroom
has grown to a client list that now includes some of the largest pharmaceutical companies in the world.
But out of that backroom has grown a belief that innovations
don’t come from behemoths. It’s at the fringe. The small team with the
guts to do something totally new. And it works. It works because we
don’t have committees telling us it won’t or can’t. So, it does and it
is really refreshing.
We’ve been specializing in innovation since 1998 and will keep doing it because that’s what makes coming into work
fun.
Doing the impossible and letting our clients reap the results. Our ultimate goal is to liberate our clients in a
way nobody else can.
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