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MessagePosté le: Sam 1 Oct - 12:46 (2016)    Sujet du message: 21 Cfr Part 11 Regulations Pdf Free Répondre en citant




21 Cfr Part 11 Regulations Pdf Free > urlin.us/4dn82









21 Cfr Part 11 Regulations Pdf Free

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4,,,,See,,,,Pharmaceutical,,,,CGMPs,,,,for,,,,the,,,,21st,,,,Century:,,,,A,,,,Risk-Based,,,,Approach;,,,,A,,,,Science,,,,and,,,,Risk-Based,,,,Approach,,,,to,,,,Product,,,,Quality,,,,Regulation,,,,Incorporating,,,,an,,,,Integrated,,,,Quality,,,,Systems,,,,Approach,,,,at,,,,www.fda.gov/oc/guidance/gmp.html.,,,,John,,,,Murray,,,,,member,,,,of,,,,the,,,,Part,,,,11,,,,Working,,,,Group,,,,(the,,,,team,,,,at,,,,FDA,,,,developing,,,,the,,,,new,,,,Part,,,,11),,,,,has,,,,publicly,,,,stated,,,,that,,,,the,,,,timetable,,,,for,,,,release,,,,is,,,,"flexible.".,,,,FDA,,,,anticipates,,,,initiating,,,,rulemaking,,,,to,,,,change,,,,part,,,,11,,,,as,,,,a,,,,result,,,,of,,,,the,,,,re-examination.,,,,Many,,,times,,,,the,,,Installation,,,and,,,Operational,,,Qualifications,,,are,,,combined,,,in,,,a,,,single,,,protocol,,,that,,,serves,,,to,,,document,,,that,,,the,,,functional,,,specifications,,,and,,,the,,,configuration,,,specifications,,,have,,,been,,,addressed,,,during,,,installation,,,and,,,can,,,be,,,verified,,,after,,,the,,,installation,,,and,,,configuration,,,stage,,,of,,,the,,,project.,,,By,,working,,with,,us,,,you,,can:,,See,,more,,reasons,,Call,,us,,today,,610-861-4701,,Contact,,Us,,Download,,our,,brochure,,.,,Guidance,,for,,Industry,,Computerized,,Systems,,Used,,in,,Clinical,,Investigations,,.,,Coverage[edit].,,,References[edit].,,Table,,of,,Contents,,.,,

The,,,,goal,,,,is,,,,that,,,,those,,,,companies,,,,implementing,,,,electronic,,,,records,,,,will,,,,benefit,,,,from,,,,across,,,,the,,,,board,,,,efficiencies,,,,,access,,,,to,,,,records,,,,,and,,,,better,,,,trending,,,,of,,,,data.,,,,Records,,,submitted,,,to,,,FDA,,,,under,,,predicate,,,rules,,,(even,,,if,,,such,,,records,,,are,,,not,,,specifically,,,identified,,,in,,,Agency,,,regulations),,,in,,,electronic,,,format,,,(assuming,,,the,,,records,,,have,,,been,,,identified,,,in,,,docket,,,number,,,92S-0251,,,as,,,the,,,types,,,of,,,submissions,,,the,,,Agency,,,accepts,,,in,,,electronic,,,format).,,,In,,,some,,,cases,,,,actual,,,business,,,practices,,,may,,,dictate,,,whether,,,you,,,are,,,using,,,electronic,,,records,,,instead,,,of,,,paper,,,records,,,under,,,,,,11.2(a).,,,The,,rule,,also,,applies,,to,,submissions,,made,,to,,the,,FDA,,in,,electronic,,format,,(e.g.,,,a,,New,,Drug,,Application),,but,,not,,to,,paper,,submissions,,by,,electronic,,methods,,(i.e.,,,faxes).,,In,,,practice,,,,the,,,requirements,,,on,,,access,,,controls,,,are,,,the,,,only,,,part,,,routinely,,,enforced.[5],,,The,,,"predicate,,,rules",,,that,,,required,,,organizations,,,to,,,keep,,,records,,,the,,,first,,,place,,,are,,,still,,,in,,,effect.,,,INTRODUCTION,,,BACKGROUND,,,DISCUSSION,,,Overall,,,Approach,,,to,,,Part,,,11,,,Requirements,,,Details,,,of,,,Approach,,,-,,,Scope,,,of,,,Part,,,11,,,Narrow,,,Interpretation,,,of,,,Scope,,,Definition,,,of,,,Part,,,11,,,Records,,,Approach,,,to,,,Specific,,,Part,,,11,,,Requirements,,,Validation,,,Audit,,,Trail,,,Legacy,,,Systems,,,Copies,,,of,,,Records,,,Record,,,Retention,,,REFERENCES,,,Guidance,,,for,,,Industry1,,,Part,,,11,,,,Electronic,,,Records;,,,Electronic,,,Signatures,,,-,,,Scope,,,and,,,Application,,,Contains,,,Nonbinding,,,Recommendations,,,This,,,guidance,,,represents,,,the,,,Food,,,and,,,Drug,,,Administration's,,,(FDA's),,,current,,,thinking,,,on,,,this,,,topic.,,,Contents,,,,1,,,,Coverage,,,,2,,,,Content,,,,3,,,,History,,,,4,,,,See,,,,also,,,,5,,,,References,,,,6,,,,External,,,,links,,,,.,,,,We,,,will,,,enforce,,,all,,,predicate,,,rule,,,requirements,,,,including,,,predicate,,,rule,,,record,,,and,,,recordkeeping,,,requirements.,,,

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