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.