strip printer ioq
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DO"#$%&' PP OV *S
Author's :Your signature indicates that you have completed this document and that, to the best of your knowledge, it is accurateand complete and it complies with existing XXX and regulatory requirements and adequately addresses the intended
purpose and scope.
This document requires the electronic approval of the following roles:
Subject Matter Expert:Your signature indicates, as a subject matter expert of the named application, that you have reviewed this document and agrees that it is accurate, complete, and contains the necessary degree of detail to accomplish the intended purpose.
S stem !ustodianYour signature indicates that you agree with this document, understand the areas of responsibility for your department,that this document was prepared with your knowledge and approval, and that this document complies with current Corporate !ocal XXXXXX , "nc. policies, procedures and current #ood $anufacturing practices as stated in thisdocument.
S stem "wner Your signature indicates that you agree with this document, understand the areas of responsibility for your department,that this document was prepared with your knowledge and approval, and that this document complies with current Corporate !ocal XXXXXX , "nc. policies, procedures and current #ood $anufacturing practices as stated in thisdocument.
#ualit AssuranceYour signature affirms awareness of this document and attests that the documentation and information contained hereincomplies with current Corporate !ocal XXXXXX, "nc. policies, procedures, applicable regulatory, requirements and current #ood $anufacturing practices as stated in this document.
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1.0 INTRODUCTION..................................................................................................................................4
1.1 PURPOSE.................................................................................................................................. 4
1.2 OBJECTIVE................................................................................................................................4
1.3 SCOPE AND QUALIFICATION APPROACH RATIONALE.........................................................4
1.4 REFERENCES........................................................................................................................... 4
1.5 RESPONSIBILITIES................................................................................................................... 5
1.6 METHODOLOGY....................................................................................................................... 5
1. SYSTEM DESCRIPTION........................................................................................................... !
2.0 INSTALLATION QUALIFICATION........................................................................................................"
2.1 D#$%&'()*)+#( V',+-+$*)+#( T' )................................................................................................. 10
2.2 E/%+ &'() *( M* #, C#& #('() V',+-+$*)+#( T' )..................................................................12
2.3 S',+* I()',-*$' DIP S +)$ ' C#(-+7%,*)+#( V',+-+$*)+#( T' ).....................................................15
2.4 U)+ +)+' V',+-+$*)+#( T' ).............................................................................................................. 1!
2.5 S *,' P*,) L+ ) V',+-+$*)+#( T' )................................................................................................ 20
3.0 INSTALLATION QUALIFICATION COMPLETION VERIFICATION......................................................22
4.0 OPERATIONAL QUALIFICATION........................................................................................................23
4.1 S)*( *, O ',*)+(7 P,#$' %,' *( T,*+(+(7 V',+-+$*)+#( T' )..................................................24
4.2 B%))#(8S +)$ 8L+7 ) V',+-+$*)+#( T' )......................................................................................... 26
4.3 P# ', L# *( R'$#9',: V',+-+$*)+#( T' )................................................................................2"
4.4 T+$;') P,+()', S: )'& V',+-+$*)+#( T' )........................................................................................31
5.0 QUALIFICATION DISPOSITION..........................................................................................................36
6.0 ATTACHMENTS................................................................................................................................... 3
A))*$ &'() N#. 1< D+ $,' *($: L#7 F#,&............................................................................................3
A))*$ &'() N#. 2< T' ) #, R'-','($' I( ),%&'() L+ )......................................................................... 3!
A))*$ &'() N#. 3< S+7(*)%,' I '()+-+$*)+#( L#7 S '')..........................................................................3"
.0 APPENDI=...........................................................................................................................................40
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