Wideman_Audit3 - No Location 1 EN-002 2 EN-001 3 BR-008 4...

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No. Location 1 EN-002 2 EN-001 3 BR-008 4 EN-002 5 BR-008 6 BR-008 1 Autoclave Operation 2 RADI Shutdown 3 Bowie Dick Test
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Description The date of this SOP is not as current as the others. Although it may still be valid, this could show a lack in the company's re The Charts given are extremely hard to read. If on a paper copy one would not be able to zoom in. It is nearly impossible to The initial date and the knowledge of who performed the task at step 20 is unknown. This should be specified This SOP does not give all the general safety working practices for using electrical systems Significant figures need to be fixed for the "weight before" There are comments listed that do not have initials and or dates.
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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.

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