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Integrity Plus downloading1/17/2024 ![]() Bad practice historical practice, Shortcuts,.What are called Data Integrity breach ?.Innocent Ignorance Carelessness/ Negligence Intentional/ MaliciousĪct is unintentionalNon-Compliance isunintentional Act may or may not beintentionalNon-compliance isunintentional Act is intentionalNon-compliance isintentionalĭiscarding sourcedocuments afteraccurate transcriptionDeleting e-files afterprinting Inaction, inattention todetail, inadequate staff,lack of supervision Data manipulation, datafalsification, mis-representation, withholding criticalinformation What is Data falsification or fabrication?.FDA have a ZERO TOLERANCE policy for data.Manufacturing medicines for life-saving.Submitting false data to the FDA is a criminal.Questioning Data Integrity Loss of Trust.DOCUMENTED RECORD available to represent the.Assures the Quality, Safety And Efficacy of the.If they find compliance gaps, regaining trust.You to do the right thing when the regulatory Time period between the inspections, we trust.Data Integrity breach Break the trust between.Ultimately Pharmaceutical quality is to AssureĮvery dose is safe and effective, free of.Risk to quality is considered as importance. the protection of the patient by managing the history of unfinished product test results.Audit trials subject to regular review should.Audit trails shall capture overwriting, aborting.Parameters used, details of a reprocessing. Include user name, date/time ofrun, integration ![]() Example audit trail for an HPLC run could.Who, what, when, and sometimes why of a record.Of events relating to the creation, modification, Secure, computer-generated, time-stampedĮlectronic record that allows for reconstruction.Data LifecycleAll phases in the life of the dataįrom generation and recording through processing.Data Governance The arrangements to ensure thatĭata, irrespective of the format in which theyĪre generated, are recorded, processed, retainedĪnd used to ensure the record throughout the data.Is usually attached to files, but invisible to It can be used to describe information such asįile type, format, author, user rights, etc. Meta Data are data used to describe other data.Retained in the format in which they were Raw Data Original records and documentation,.Legible, contemporaneously recorded, original (or Secure manner, so that they are attributable, The data should be collected and maintained in a.Maintained throughout the data life cycle. consistent, accurate, trustworthy, reliableĪnd that these characteristics of the data are.Data integrity is the degree to which data. ![]() Recordseverything thats stored electronically.
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