Biomedical Engineering Reference
In-Depth Information
SOP No. QCS-018.00 Effective date: mm/dd/yyyy
Approved by:
LEVEL 3
Page 3 of 4
Attachment No.:
Issued on:
Revision No.:
Initiator name:
B. Expanded investigation:
•Reviewinformationavailableaboutthematerialundertest
•Themanufacturingprocess
•Historyofthebatches
•Resultsofin-processtesting
•Resultsofothertestsconducted
•Suppliercertiicateofanalysis
•Deicienciesdeviationidentiiedduringreview
•Actualandprobablecause
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