Whether a FDA-regulated company is training its employees on the basics of 21 CFR Part 11 or training employees to become users of a Part-11 compliant electronic system, part 11 training is essential to achieving FDA 21 CFR Part 11 inspection requirements.
The Part 11 validation requires careful testing and corresponding documentation. This documentation ensures that the electronic system has been programmed to perform the tasks necessary to maintain compliance with Part 11 rules and FDA 21 CFR Part 11 inspection regulations. To easily streamline the Part 11 validation process before FDA 21 CFR Part 11 inspection it is useful to ask the software vendor if validation documentation, tools or solutions are available. For instance, MasterControl, Inc., a developer of document control, quality management and product lifecycle software solutions, provides validation documentation, a validation toolkit, validation consultation, validation training and/or full-scale validation services.
Discover how MasterControl software can manage your processes, all while mitigating risk, improving speed-to-market, and generating ROI.
Get in-depth, comprehensive resources to guide development of your programs and processes.
Get insider information about the most relevant issues, and how to navigate and overcome the complexities of FDA regulations.