返回
6 - Critical Example of Compliant Equipment Qualification - Automatic

6 - Critical Example of Compliant Equipment Qualification - Automatic

ID：40385775

大小：1.32 MB

页数：42页

时间：2019-08-01

6 - Critical Example of Compliant Equipment Qualification - Automatic_第1页
6 - Critical Example of Compliant Equipment Qualification - Automatic_第2页
6 - Critical Example of Compliant Equipment Qualification - Automatic_第3页
6 - Critical Example of Compliant Equipment Qualification - Automatic_第4页
6 - Critical Example of Compliant Equipment Qualification - Automatic_第5页
资源描述：

《6 - Critical Example of Compliant Equipment Qualification - Automatic》由会员上传分享，免费在线阅读，更多相关内容在学术论文-天天文库。

1、CriticalExampleofCompliantEquipmentQualification-AutomaticIntegrityTestersModule6CopyrightMerckMillipore2011.1PresentationRegulatorybasisforequipmentqualificationQualificationdefinitionsExamplesofkeyelementsofdesignqualificationanduserrequirementspecificationKeyelementsofequipmentinstallationq

2、ualificationKeyelementsofequipmentoperationalqualificationKeyelementsofequipmentprocessqualificationWalkthroughatypicalIQ/OQprotocol21CFRPart11–Electronicsignatures&recordsCopyrightMerckMillipore2011.2FDADefinitionsInstallationQualification(IQ):Establishingconfidencethatprocessequipmentandanc

3、illarysystemsarecapableofconsistentlyoperatingwithinestablishedlimitsandtolerances.ProcessPerformanceQualification(PQ):EstablishingconfidencethattheprocessiseffectiveandreproducibleValidation:Establishingdocumentedevidencewhichprovidesahighdegreeofassurancethataspecificprocesswillconsistentl

4、yproduceaproductmeetingitspre-determinedspecificationsandqualityattributesCopyrightMerckMillipore2011.3DefinitionsCommissioning:Awellplanned,documented,andmanagedengineeringapproachtothestart-upandturnoveroffacilities,systems,andequipmenttotheEnd-Userthatresultsinasafeandfunctionalenvironmentt

5、hatmeetsestablisheddesignrequirementsandstakeholderexpectationsNote:CommissioningisNOTQualificationCopyrightMerckMillipore2011.4WhatDoesPICSSay“ItisarequirementofGMPthateachpharmaceuticalcompanyidentifieswhatqualificationandvalidationworkisrequiredtoprovecontrolofthecriticalaspectsoftheirparti

6、cularoperation”RECOMMENDATIONSONVALIDATIONMASTERPLANINSTALLATIONANDOPERATIONALQUALIFICATION,PI006-21July2004“Thepurposeofthisdocumentistoproviderecommendationsandbackgroundinformationconcerningcomputerisedsystemsthatwillbeofassistancetoinspectorsfortrainingpurposesandduringtheinspectionofcomp

7、uterisedsystems.”“Regulatedusersneedtobeabletoprovideevidencefortheircomputerisedsystemstodemonstratetheirrange,complexity,functionality,controlandvalidationstatus.”GOODPRACTICESFORCOMPUTERISEDSYSTEMSINREGULATED“GXP”ENVIRONMENTS,PI011-

当前文档最多预览五页，下载文档查看全文

此文档下载收益归作者所有

当前文档最多预览五页，下载文档查看全文
温馨提示：
1. 部分包含数学公式或PPT动画的文件，查看预览时可能会显示错乱或异常，文件下载后无此问题，请放心下载。
2. 本文档由用户上传，版权归属用户，天天文库负责整理代发布。如果您对本文档版权有争议请及时联系客服。
3. 下载前请仔细阅读文档内容，确认文档内容符合您的需求后进行下载，若出现内容与标题不符可向本站投诉处理。
4. 下载文档时可能由于网络波动等原因无法下载或下载错误，付费完成后未能成功下载的用户请联系客服处理。