FDA Regulated Firms Must Ensure Part 11 Compliance to Generate Accurate and Usable Data

21 CFR Part 11 compliance has to be adopted not just to avoid the wrath of the regulator, but also to ensure that data captured electronically is accurate and clean. With the widespread adoption of electronic systems to capture and record data has also come the risk of manipulation and loss.

This is the biggest risk for FDA regulated companies that rely heavily on accuracy of data in all processes – from clinical trials to production to customer complaint management. The important of Part 11 compliance can therefore not be stressed strongly enough – it’s not just the risk of warning letters that come with non-compliance, but consumer safety and the reputation of a company as well.

How Can FDA Compliance Training Help?

The areas highlighted above are just a small part of the wide range of practices and processes for FDA compliance. Subjects such as FDA compliance are multi-faceted and complex and can be better understood after attending a training course such as the ones offered by “SignupTraining.com”.

Our courses are available as live webinars, training recordings and in-person seminars. We also offer customized training courses developed in conjunction with organizations that wish to train large groups of their employees.

We offer training in other areas FDA compliance such as marketing and promotion, QSR, regulatory submissions and handling regulatory audits and inspections. If you are interested in our wide range of FDA compliance training courses, please call us at - 1-888-844-8963 or visit www.signuptraining.com

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