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MessagePosté le: Mer 5 Oct - 13:07 (2016)    Sujet du message: Annex 11 Gmp Pdf Free Répondre en citant




Annex 11 Gmp Pdf Free > bit.ly/2e1uCRi























































Annex 11 Gmp Pdf Free

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The...appropriate...measures...should...be...based...on...a...risk...assessment...."Good...Practices...for...Computerized...Systems...in...GxP...Regulated...Environments,"...PIC/S...PI...011-3,...September...2007....Electronic....Signatures....Speaking....strictly....about....e-sigs,....Part....11....goes....beyond....Annex....11.....Lopez..may..be..reached..at..olopez6102msn.com...The..direct..EU..Annex..11..corresponding..e-sigs..guideline..associated..with..Part..11..regulation..can..be..found..in..parentheses..above...The..second..common..area..is..the..elements..covered..in..Part..11.10,..Controls..for..Closed..Systems...The....first....common....area....is....the....electronic....signatures....(e-sigs)....elements....within....these....documents.....Use...of...computer-generated,...time-stamped...audit...trails...(11.10(e),...(k)(2)...and...associated...requirements...in...11.30).One...of...the...first...references...on...the...use...of...audit...trails...in...FDA...guidelines...is...from...the...1978...current...good...manufacturing...practices...(cGMP)...preamble....Such...computer...systems...must...be...validated...to...ensure...accuracy,...reliability,...consistent...intended...performance,...and...the...ability...to...discern...invalid...or...altered...records.Software...for...the...above...applications...may...be...developed...in-house...or...under...contract....

.....One..of..the..main..principles..of..this..Annex..states..that:.."The..application..should..be..validated;..IT..infrastructure..should..be..qualified."A..significant..and..essential..activity..at..the..beginning..of..a..computer..system's..life..cycle..is..to..establish..the..intended..use..and..proper..performance..of..computer..systems...Planned...and...expected...performance...is...based...upon...predetermined...design...specifications,...consequently,..."intended...use."All...computer...systems...automating...any...regulated...function...must...be...validated...for...its...intended...use....All....production....and/or....quality....system....software,....even....if....purchased....off-the-shelf,....should....have....documented....requirements....that....fully....define....its....intended....use,....and....information....against....which....testing....results....and....other....evidence....can....be....compared,....to....show....that....the....software....is....validated....for....its....intended....use.Appropriate....installation....and....operational....qualifications....should....demonstrate....the....suitability....of....computer....hardware....and....software....to....perform....assigned....tasks.....manufacturers....who....wish....EU....market....approval....need....to....take....it....into....account....as....an....applicable....requirement.....The...objective...of...the...backup...is...to...guarantee...the...availability...of...the...stored...data...and,...in...case...of...loss...of...data,...to...reconstruct...all...GMP-relevant...documentation.According...to...11-7.2...and...similarly...to...an...electronic...file,...the...integrity...and...accuracy...of...backup...data...and...the...ability...to...restore...the...data...should...be...verified...during...validation...and...periodically...(Annex...11-7.1)....For....the....purpose....of....this....analysis....it....is....required....to....consider....the....Part....11....Guideline....(2003).....Part..11..establishes..the..requirements..for..the..technical..and..procedural..controls..that..must..be..met..by..the..regulated..user..if..the..regulated..user..chooses..to..maintain..regulated..records..electronically...The....requirements....covered....by....Part....11....on....the....controls....for....closed....systems....are:....validation,....copy....and....protection....of....e-recs,....audit....trails,....system....documentation,....computer....system....access,....and....experience....of....people....developing/maintaining/using....the....computer....system.....

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