All the products that [pharmaceutical companies] make today require a certain amount of increased focus on product safety,
increased focus on regulatory reporting. We have to meet the regulations, or else we're not sitting here as a vendor true
to the market.... So from a SAP perspective, yep, we do electronic signature. Yep, we do [21 CFR] Part 11. Yep, we do Sarbanes-Oxley. Yes, we do all these different things, but at the end of the day, the cycle is still
seven years, a billion dollars, to bring a new product to market. So how do we scrunch that down?
I think we all agree that consistency and the ability to put on the brakes, all of these are very important. But the challenge
that we've seen as far as the FDA is concerned [is that] they put this little letter "c" in front of GXP [where the] "c" really
means "current" [i.e., the agency's current expectations with regard to handling compliance]. The Code of Federal Regulations has not changed that substantially or drastically, [however,] the interpretation by regulatory bodies [as to what is current]
is changing. [For instance, one important aspect of compliance, about which] our customers [care very much] is the ability
to automatically trend and keep track of incidents that may happen across their [organization]. [Customers need] the means
to always have their fingers on the pulse and make sure that if something goes wrong, they can catch it as fast as possible.
[This is] one way to [address such] challenges. [Take] corrective action and preventive actions in real time rather than [rely
on individuals to run reports and independently determine appropriate actions].
Knowing that is not good enough.... At the end of the day, it's what business processes allow you to go back to product safety
? Several key customers...can manufacture products that are in compliance, that manage the risk aspects of it, but may I suggest
to you that there are those types of players that are out there...that can actually counterfeit these products, introduce
them to the market, and threaten product safety from that perspective.
And here the conversation veers into what a company can do to prevent such events from happening and how to respond once they
do. Bottum replied that the ability to prevent counterfeiting constituted a "very narrow view of risk."
What is relatively new in the life sciences companies and relatively new among vendors like us, is offering organized ways
for management to manage risk... Your perspective is largely based on where you sit. Many of the risks we deal with are not
risks that can be systematized. Risk cannot be eliminated.
Compliance is always a combination of process documentation and recording of deviations (potential or real) from such processes.
What do you do when the safety of a product has been compromised? What do you do if a drug...does not have the ingredients
that it's supposed to have? [Nowadays, the automatic detection and trending is available ... it wasn't] 10 or 20 years ago....
[The quality system] needs to kick in and [raise a red flag], and say, '[You should apply] those brakes.' [The system may
even automatically launch an investigation... [A good program should have a built-in 24/7] business rule engine [where companies
configure] all their business rules [to enforce processes,] trending, and all actions to be taken.
[An ERPtool] is an essential solution to do exactly what it's meant to do... introduce standard, predictable, and consistent
processes. When you look at what we do, what TrackWise does, it's actually putting in place a quality system to manage all
the actions to be taken [when incidents happen ... the products are really very complementary].