FDA Plans New Part 11 Inspections

Since 2004, the implementation of the 21 CFR Part 11 requirements did not seem to have a very high priority with the FDA any more. Quite recently, on 8 July 2010, the FDA officially announced that it would focus on this topic in a series of inspections in the near future. With this measure, the FDA intends to find out how the Part 11 requirements are currently implemented by the industry.

Requirements on electronic records and electronic signatures were laid down in the US CFR 21 Part 11 in 1997. Hardly any other requirement in the GMP-regulated environment was as hotly debated as this one. Inspections during that period - also of renowned pharmaceutical companies - led to a number of observations and even to warning letters. The industry raised the question if the very far-reaching requirements and the resulting high investment cost for IT systems actually contributed to increasing patient safety.

As a consequence of the public discussions, the FDA withdrew or significantly corrected several original interpretations. In the end, the FDA published its final interpretation of 21 CFR Part 11 in the Guidance for Industry "Part 11, Electronic Records; Electronic Signatures - Scope and Application" in 2003. The Agency's expectations on the implementation of the Part 11 requirements were expressed through this guidance for industry in a much more understandable and clear way. Within the framework of the now planned inspections, the FDA wants to continue exercising enforcement discretion. This scope of discretion was granted by the guidance of industry dating back to 2003.

Further information can be found in the FDA's announcement.

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