Quality management, always an FDA focus during inspections, could become even more important in 2017 as FDA priorities take shape.

In December 2016, Director Janet Woodcock laid out some of the broader goals for 2017 around the same time Congress approved the epic 21st Century Cures Act. If all goes according to plan, the FDA will have more funding to do its job—including more inspections of life sciences manufacturers.

The 21st Century Cures Act gives the FDA a bonus of $500 million over 10 years to further fund an initiative to use real-world evidence in regulatory decisions. That makes it all the more important for manufacturers to have a strong document management system in place to be able to organize, access, and have the ability to provide detailed data to the agency if requested.

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