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May 9, 2003 | Images and accompanying data are part of a drug approval submission to the FDA. 21 CFR Part 11 guidelines require that images from which data were extracted be stored and not altered in any way. A time-stamped audit trail must reveal what manipulations have been performed on the image, and reconstructing that path must be made clear to the FDA.

Managed storage is a must for images. After all, says Mike Esterman, senior information consultant at Lilly Research Laboratories, when it comes to 21 CFR Part 11, "After Y2K, we need something else to panic about." And there's another reason to consider image management seriously: "It's the law."

During a recent Webcast through Scimagix (scimagixevents.webex.com/scimagixevents), imaging analysts at Eli Lilly discussed the ins and outs of adhering to the federal guidelines:

What 21 CFR Part 11 covers

  • The FDA expects you to be able to verify where any data that might be submitted came from, what they are, and how they were processed

What to do 

  • Make sure the image is accurate, complete, uncompressed, and that all the metadata about the image have been preserved

How to do it

  • The image should be stored in the acquisition mode even if it is analyzed in a different mode
  • Store a reader along with the image to avoid media obsolescence
  • CDs and DVDs are preferable to tape

How long to do it 

  • The retention period could be considerable, so you need managed image storage
  • Ensure that the data are retrievable by keeping old software and hardware or migrating data to a new platform, and (re)training personnel on the usage of outdated systems



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