Apheresis Technologies Trials Software & Part 11

Failure to validate the EtO sterilization process for ATI plasma exchange tubing setsand off-the-shelf software for compiling clinical trial data. Also there are no procedures established and maintained for monitoring and controlling the process parameters for the ATI plasma exchange tubing sets to ensure that specified requirements are met as required by 21 CFR 820.75. For example, there is no documentation covering EtO sterilization and manufacturing processes for the ATI plasma exchange tubing sets.

There is no documentation covering Excel application software, or any procedures
instituted covering the protection of electronic records or an established back-up
system [FDA 483, [tern #s 7 & 8].

SoftwareCPR Keywords: part 11, COTS, OTS, software validation, production software.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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