Change Control | PharmaBharat Tools

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Change Control | PharmaBharat Tools

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Source Document Verification Deviation Quality Control Case Processing Audit Trail Data Integrity Reconciliation Corrective Action Preventive Action Root Cause Analysis(RCA)Source Document Retention Quality Metrics PV Key Performance Indicator PV(KPI)Document Control Change Control Incident Management PV Coding Quality Consistency Check Completeness Check Correctness Check ALCOA(ALCOA)ALCOA Plus Source Data Verification(SDV)Traceability Reconciliation Discrepancy Reconciliation Report Archiving PV Amendment Audit Trail Corrective and Preventive Action(CAPA)Case Lock Coding Consistency Compliance Rate Controlled Document Data Integrity(DI)Deviation Escalation Performance Metric(KPI)Peer Review Quality Assurance(QA)Quality Control(QC)Reconciliation Root Cause Analysis(RCA)Standard Operating Procedure(SOP)Source Data Verification(SDV)Training Record System Validation

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PV Quality ReviewChange Control

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Document Control Incident Management PV

Change Control

Quality Review

Definition

Process for reviewing and approving changes (e.g., to systems, processes) before implementation.

Example

Change control for safety database upgrade.

Regulatory source

GVP I, 21 CFR 11

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