Electronic GLP Training - 7 Simple and Foundational Capabilities

Staying compliant with current FDA regulationsthe conduct of or responsible for the supervision
isn't for weaklings or the faint of heart. Challengesof a nonclinical laboratory study shall have
presented in the GxP compliance environment caneducation, training, and experience, or combination
significantly retard quality related processes andthereof, to enable that individual to perform the
cost companies millions of dollars in managementassigned functions."2
revenue. Sure, the GxPs are designed to help butGLP training might be performed annually,
are life science companies paying too high a price?biannually and perhaps even more frequently. GLP
Perhaps life science companies are paying too hightraining not only encourages compliance but
a price but is it the FDA that's really causing theactually creates the foundation for employees
problem?who know what they are doing and why they
The following quote1 seems to infer that the FDAare doing it from the start of any life science
is not the epicenter of this GIANT problem andproject. It's easy to see that GLP training lies at
that another culprit is. In fact, the quote-thoughthe foundation of the GLP regulations themselves
referring to the pharmaceutical industry--may inbut can GLP training be electronically controlled?
many ways be a reflection of the entire lifeThe answer is that to a great degree, yes, GLP
science industry and is surely a support for thetraining can be controlled and effectively
theory that regulations, when monitored andmonitored.
controlled correctly, may actually be much less ofGLP Training Software
a burden than many life science companiesSo, life science professionals are probably
assume:wondering what the secret sauce is. Where is this
"The FDA's campaign to encourage allsolution that can create a solid base for GxP
pharmaceutical companies to modernize theircompliance? The answer is that there may be a
paper-based (or partially electronic) processes isvariety of GLP training software solutions that
believed to be due to the slowdown in themeet a life science company's needs. However,
availability of innovative medical products.there are a few features and/or benefits that
According to one ongoing study, the cost andGLP regulated life science companies should look
time of bringing a drug to market jumped fromfor when searching for a GLP training solution.
$231 million and 8-10 years in 1990, to $802 millionFeatures and Benefits
and 10-12 years in 2001, to the current estimateWhen searching for a GLP training solution(s), life
of more than $1 billion and 12-14 years. Thescience professionals should search for the
reason for this increase is thought to be thefollowing:
combined result of increased federal regulation• Solution(s) that track all training related
and inefficiencies throughout the productdocumentation;
development process."• Solution(s) that trigger training tasks when
The GLPs and GLP Trainingessential GLP related documentation is changed;
This encouragement towards modernized• Solution(s) that automate the routing of
solutions applies to all areas of GxP control andtraining tasks, follow-ups, escalations, etc.
since the GLPs are the foundation for the• Solution(s) that administer and grade
effective and accurate beginning of a life scienceexaminations;
product, it can be safely assumed that electronic• Solution(s) that provide reporting features
GLP management solutions would be highlyfor easier analytics;
recommended by the FDA.• Solution(s) that are web-based;
Who cares though? It doesn't matter whether• Solution(s) can be launched from one
the FDA says so. What really counts is what lifeintegrated platform.
science companies think.7 Simple Capabilities
What good is electronic GLP management...really?These 7 simple capabilities, when found in a
Electronic GLP Training Softwaresoftware solution, should be considered for the
The GLP regulations require training. According toautomation of GLP training processes.
21 CFR section 58.29, "Each individual engaged in