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Unformatted text preview: Video AudiT Didn'± show ±ha± opera±or used ±hermal gloves ±o load ±he i±ems. Al±hough ±hey looked emp±y, i± is a good practc e When shu²ng down ±he RADI sys±em, i± wasn’± speciFed if RADI uni±s were in "s±andby" mode and ±he wa±er lev e The opera±or said he performs ±he ±es± once a week. I± is s±a±ed in ±he procedure ±ha± ±his ±es± should be comple± e SOP # Reference 21 CFR Part 211 Reference(s) subpart J Sec. 188 Subpart J Sec. 188 GL-009 7.1.5 Subpart J Sec. 188 Subpart D Sec 68 Subpart J Sec. 188 GL-009 7.1.12 subpart J Sec. 188 CS-002 7.2.2 Subpart B Sec 28 EN-001 Subpart D Sec 67 CS-002 7.7.11 Subpart D Sec 67...
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- Spring '16
- L. Ron Hubbard, ZOOM, Initial, Title 21 CFR Part 11, subpart j sec.