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Demystifying Software Validation:Learn What Software ValidationMeans for You and Your LabWhitepaperIntroductionThe term “software validation” can trigger many responses, including confusionand even anxiety. This article provides a foundation for thinking about softwarevalidation based on expert articles and U.S. Food and Drug...
Key words
validation, validationvendor, vendorsystems, systemssoftware, softwarecomputerized, computerizedsystem, systemdata, datavendors, vendorsfda, fdaaudit, auditrecords, recordscontext, contexthow, howcan, canprocesses
C10G-E071WHITEPAPERWhat you should know to assurelaboratory data integrity withLabSolutionsIn order to assure data integrity in life sciences industry laboratories it is necessaryto address procedural, behavioural and technical controls. While it is regulatedcompanies who are accountable for data integrity within their...
Key words
data, dataintegrity, integrityshould, shouldcompanies, companiescontrols, controlslaboratory, laboratoryrecords, recordsregulated, regulatedinstruments, instrumentslabsolutionscs, labsolutionscselectronic, electronicmanagement, managementlabsolutions, labsolutionsaudit, auditsystems
[ WHITE PAPER ]The Role of Empower Chromatography Data System in Assistingwith Electronic Records Regulation ComplianceINTRODUCTIONThe objective of this white paper is to discuss the 21 CFR Part 111 and EU EudraLex Annex 112 compliancereadiness of Waters™ Empower™ Software for...
Key words
electronic, electronicempower, empowerrecords, recordschromatogragphy, chromatogragphycompliance, compliancedata, datapaper, paperassisting, assistingsignature, signaturereadable, readablesignatures, signaturesregulation, regulationwhite, whiterecord, recordaudit
[ WHITE PAPER ]Data Integrity for Your Laboratory Computerized SystemsLynn Archambault, Informatics and Regulatory ComplianceProduct Marketing Manager, Waters CorporationINTRODUCTIONElectronic data and computerized systems introduce new challenges to maintaining dataintegrity. With increased scrutiny from regulatory authorities, companies need to have athorough...
Key words
data, datacomputerized, computerizedintegrity, integrityunderstand, understandreview, reviewpaper, paperlaboratory, laboratorysystems, systemsaudit, auditanalytics, analyticsproject, projectempower, empowerperiodic, periodicyour, yourwhat
 

Similar PDF

Demystifying Software Validation:Learn What Software ValidationMeans for You and Your LabWhitepaperIntroductionThe term “software validation” can trigger many responses, including confusionand even anxiety. This article provides a foundation for thinking about softwarevalidation based on expert articles and U.S. Food and Drug...
Key words
validation, validationvendor, vendorsystems, systemssoftware, softwarecomputerized, computerizedsystem, systemdata, datavendors, vendorsfda, fdaaudit, auditrecords, recordscontext, contexthow, howcan, canprocesses
C10G-E071WHITEPAPERWhat you should know to assurelaboratory data integrity withLabSolutionsIn order to assure data integrity in life sciences industry laboratories it is necessaryto address procedural, behavioural and technical controls. While it is regulatedcompanies who are accountable for data integrity within their...
Key words
data, dataintegrity, integrityshould, shouldcompanies, companiescontrols, controlslaboratory, laboratoryrecords, recordsregulated, regulatedinstruments, instrumentslabsolutionscs, labsolutionscselectronic, electronicmanagement, managementlabsolutions, labsolutionsaudit, auditsystems
[ WHITE PAPER ]The Role of Empower Chromatography Data System in Assistingwith Electronic Records Regulation ComplianceINTRODUCTIONThe objective of this white paper is to discuss the 21 CFR Part 111 and EU EudraLex Annex 112 compliancereadiness of Waters™ Empower™ Software for...
Key words
electronic, electronicempower, empowerrecords, recordschromatogragphy, chromatogragphycompliance, compliancedata, datapaper, paperassisting, assistingsignature, signaturereadable, readablesignatures, signaturesregulation, regulationwhite, whiterecord, recordaudit
[ WHITE PAPER ]Data Integrity for Your Laboratory Computerized SystemsLynn Archambault, Informatics and Regulatory ComplianceProduct Marketing Manager, Waters CorporationINTRODUCTIONElectronic data and computerized systems introduce new challenges to maintaining dataintegrity. With increased scrutiny from regulatory authorities, companies need to have athorough...
Key words
data, datacomputerized, computerizedintegrity, integrityunderstand, understandreview, reviewpaper, paperlaboratory, laboratorysystems, systemsaudit, auditanalytics, analyticsproject, projectempower, empowerperiodic, periodicyour, yourwhat
 

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