Archiving PV | PharmaBharat Tools

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Archiving PV | PharmaBharat Tools

Categories

Aggregate Reporting(35)

AI & ML in Pharmacovigilance(21)

Audit & Inspection Readiness(30)

Audits & Inspections(20)

Case Intake & Triage(42)

Case Processing & Data Entry(49)

India CDSCO & PvPI(20)

Data Privacy & Masking(21)

GVP & ICH Updates 2026(9)

Medical Review(26)

Quality Review(46)

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

Real-World Data & RWE(21)

Regulatory Harmonization(12)

Regulatory Reporting(83)

Risk Management(68)

Seriousness & Causality Assessment(34)

Signal Detection & Validation(43)

Signal Management(20)

Progress

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PV Quality ReviewArchiving PV

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Reconciliation Report Amendment

Archiving PV

Quality Review

Definition

Long-term retention of PV records in readable form per retention policy.

Example

Cases archived after 10 years in validated archive.

Regulatory source

GVP I

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