Many FDA-regulated companies are saving time and money by investing in automated quality management and document control systems. These systems require FDA 21 CFR Part 11 validation (see 21 CFR Part 11 Section 11.10a.)
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 regulations. To easily streamline the FDA 21 CFR Part 11 validation process 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, FDA 21 CFR Part 11 validation training and/or full-scale validation services.
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