Comply with Data Integrity Regulations with Chromeleon CDS Software
Presentations | 2016 | Thermo Fisher ScientificInstrumentation
Software
IndustriesManufacturerThermo Fisher Scientific
Key wordsaudit, record, trails, data, chromeleon, integrity, cds, management, metadata, cgmp, backup, summary, trail, electronic, entries, contemporaneous, introduction, original, actions, regulatory, what, archive, version, file, term, bodies, relating, authenticity, storage, copy, documented, chromatography, changes, you, events, security, comments, history, current, change, hand, maintained, meaningless, each, how, checksums, privileged, barrington, clarifies, questions
Similar PDF
Data integrity: audit trails with ease of review
2018|Thermo Fisher Scientific|Technical notes
WHITE PAPER 72664 Data integrity: audit trails with ease of review Author Summary Shaun Quinn, Marketing Manager Chromatography Software, Thermo Fisher Scientific Audit Trails are an important regulatory requirement and are a proven effective means of detecting data integrity issues.…
Key words
audit, audittrail, trailtrails, trailsdata, datachromeleon, chromeleonreview, reviewcds, cdsvault, vaultversioning, versioningstamps, stampsraw, rawrecorded, recordeddate, datechanges, changesmetadata
Why is Electronic CDS Data a Major Data Integrity Concern for Regulators?
2017|Waters|Technical notes
[ WHITE PAPER ] Why is Electronic CDS Data a Major Data Integrity Concern for Regulators? Tools and advice on electronic Data Integrity and how it specifically applies to chromatography systems and the challenges they present in audit situations Heather…
Key words
data, dataintegrity, integrityregulators, regulatorsintegration, integrationelectronic, electronicpaper, paperwhy, whyconcern, concernwhite, whiteaudit, auditoos, oosconcerns, concernssystems, systemsoriginal, originalprocessing
The Role of UNIFI Scientific Information System in Assisting with Electronic Records Regulation Compliance
2018|Waters|Technical notes
[ WHITE PAPER ] The Role of UNIFI Scientific Information System in Assisting with Electronic Records Regulation Compliance INTRODUCTION The objective of this white paper is to discuss the electronic record and Data Integrity compliance readiness of Waters™ UNIFI™ Scientific…
Key words
unifi, unifielectronic, electronicrecords, recordsassisting, assistingdata, datacompliance, compliancesignature, signaturepaper, paperaudit, auditreadable, readableregulation, regulationwhite, whiterole, roleuser, userreview
The Role of Empower Chromatography Data System in Assisting with Electronic Records Regulation Compliance
2018|Waters|Technical notes
[ WHITE PAPER ] The Role of Empower Chromatography Data System in Assisting with Electronic Records Regulation Compliance INTRODUCTION The objective of this white paper is to discuss the 21 CFR Part 111 and EU EudraLex Annex 112 compliance readiness…
Key words
electronic, electronicempower, empowerrecords, recordschromatogragphy, chromatogragphycompliance, compliancedata, datapaper, paperassisting, assistingreadable, readablesignature, signatureregulation, regulationsignatures, signatureswhite, whiterecord, recordaudit