Image via WikipediaAs detailed within the post 21 CFR Part 11 Warning Letters the FDA are planning to start conducting part 11 inspections soon.
Published on the FDA website the agency states:
The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003
Published on the FDA website the agency states:
The Agency (FDA) will be conducting a series of inspections in an effort to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003