FDA Part 11 Compliance


FDA Part 11 compliance is a huge issue for all companies that are regulated by the FDA (Food and Drug Administration), including but not limited to food, pharmaceuticals, biotechnology institutions and clinical laboratories.

regulation, introduced in 1997, says the terms and conditions to ensure that electronic records and signatures can be considered reliable and trustworthy.

This includes carrying out the necessary controls and procedures, such as auditing, system validation, audit trails and electronic signatures.

Essentially, FDA Part 11 compliance rule on how to store files and documents that show that you are in compliance with the plethora of other regulations set by the FDA. So, although the FDA good intentions – to protect the public from harm -. It is easy to see how compliance can become so burdensome for FDA regulated companies

And with the recent news that President Obama is, once again, increase funding for FDA – another 23% (down 19% from 09 ) -. These rules are only going to get tighter in the coming years

In fact, this increase rigorous and regulatory requirements is shown by FDA sent nearly double the number of law enforcement letters to pharmaceutical companies in 2009 compared to those sent out in 2008. And the expectation this figure to double by the end of 2010, the FDA regulatory agencies really need to be “on-the-ball” if they want to avoid enforcement action.

So, how can these rules be treated effectively, efficiently and in a manner consistent with FDA part 11 compliance?

With a learning management system.

Learning management systems provide easy-to-use platform for employees and supervisors alike to deal with training workload, make sure it is completed on time and to an acceptable standard.

For FDA Part 11 compliance, learning management system also includes the ability to record, review and allow all training records – providing reliable, regulatory compliant platform so that you and your employees can focus on more important things.


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