Staying compliant with current FDA regulations isn"t for weaklings or the faint of heart. Challenges presented in the GxP compliance environment can significantly retard quality related processes and cost companies millions of dollars in management revenue. Sure, the GxPs are designed to help but are life science companies paying too high a price?
Perhaps life science companies are paying too high a price but is it the FDA that"s really causing the problem?
The following quote1 seems to infer that the FDA is no t the epicenter of this GIANT problem and that another culprit is. In fact, the quote—though referring to the pharmaceutical industry--may in many ways be a reflection of the entire life science industry and is surely a support for the theory that regulations, when monitored and controlled correctly, may actually be much less of a burden than many life science companies assume:
"The FDA"s campaign to encourage all pharmaceutical companies to modernize their paper-based (or partially electronic) processes is believed to be due to the slowdown in the availability of innovative medical products. According to one ongoing study, the cost and time of bringing a drug to market jumped from $231 million and 8-10 years in 1990, to $802 million and 10-12 years in 2001, to the current estimate of more than $1 billion and 12-14 years. The reason for this increase is thought to be the combined result of increased federal regulation and inefficiencies throughout the product development process."
The GLPs and GLP Training
This encouragement towards modernized solutions applies to all areas of GxP control and since the GLPs are the foundation for the effective and accurate beginning of a life science product, it can be safely assumed that electronic GLP management solutions would be highly recommended by the FDA.
Who cares though? It doesn"t matter whether the FDA says so. What really counts is what life science companies think.
What good is electronic GLP management...really?
Electronic GLP Training Software
The GLP regulations require training. According to 21 CFR section 58.29, "Each individual engaged in the conduct of or responsible for the supervision of a nonclinical laboratory study shall have education, training, and experience, or combination thereof, to enable that individual to perform the assigned functions."2
GLP training might be performed annually, biannually and perhaps even more frequently. GLP training not only encourages compliance but actually creates the foundation for employees who know what they are doing and why they are doing it from the start of any life science project. It"s easy to see that GLP training lies at the foundation of the GLP regulations themselves but can GLP training be electronically controlled?
The answer is that to a great degree, yes, GLP training can be controlled and effectively monitored.
GLP Training Software
So, life science professionals are probably wondering what the secret sauce is. Where is this solution that can create a solid base for GxP compliance? The answer is that there may be a variety of GLP training software solutions that meet a life science company"s needs. However, there are a few features and/or benefits that GLP regulated life science companies should look for when searching for a GLP training solution.
Features and Benefits
When searching for a GLP training solution(s), life science professionals should search for the following:
• Solution(s) that track all training related documentation;
• Solution(s) that trigger training tasks when essential GLP related documentation is changed;
• Solution(s) that automate the routing of training tasks, follow-ups, escalations, etc.
• Solution(s) that administer and grade examinations;
• Solution(s) that provide reporting features for easier analytics;
• Solution(s) that are web-based;
• Solution(s) can be launched from one integrated platform.
7 Simple Capabilities
These 7 simple capabilities, when found in a software solution, should be considered for the automation of GLP training processes.
1 mastercontrol.com/newsletter/feature/transition_from_paper_0208.html?source=n3w5
2 accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58&showFR=1