FDA Part 11 compliance is a huge issue for all firms that are regulated by the FDA (Food and Drug Administration), including but not limited to food manufacturers, pharmaceutical companies, biotechnology organisations, and clinical laboratories.
This regulation, introduced in 1997, states the terms and conditions required to ensure that electronic records and signatures can be considered trustworthy and reliable.
This involves the implementation of necessary controls and procedures such as auditing, system validation, audit trails, and electronic signatures.
Essentially, FDA Part 11 compliance is a rule on how to store records and documentation that show you are complying with the plethora of other rules set by the FDA. So, although the FDA have good intentions – to protect the public from harm – it’s easy to see how compliance can become such a burden for FDA regulated companies.
And with recent news that President Obama is, once again, increasing funding for the FDA – by another 23% (on top of a 19% increase from 09) – regulations are only going to get tighter in the next few years.
In fact, this increase in stringency and regulatory requirements is displayed by the fact that the FDA sent almost double the number of enforcement letters to pharmaceutical companies in 2009 when compared to those sent out in 2008. And with expectations of this figure to double by the end of 2010, FDA regulated organisations really need to be ‘on-the-ball’ if they want to avoid enforcement action.
So, how can these regulatory requirements be handled effectively, efficiently and in a way that conforms to FDA Part 11 compliance?
With a good learning management system.
Learning management systems provide an easy-to-use platform for employees and supervisors alike to handle the training workload, ensuring it is completed on-time and to an acceptable standard.
For FDA Part 11 compliance, learning management systems also contain the ability to record, audit, and authorise all training records – providing a solid, regulatory compliant platform so that you and your employees can focus on more important things.