Document Request List | PharmaBharat Tools

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Document Request List | PharmaBharat Tools

Categories

Aggregate Reporting(35)

AI & ML in Pharmacovigilance(21)

Audit & Inspection Readiness(30)

Inspection Readiness PV Inspection Finding QPPV(QPPV)Pharmacovigilance System Master File(PSMF)Corrective and Preventive Action(CAPA)Standard Operating Procedure(SOP)Training and Competency PV Outsourcing PV Regulatory Authority Request Inspection Scope PV Effectiveness Check CAPA PV Agreement Ad Hoc Request Inspection Report Critical Finding Major Finding Minor Finding Follow-Up Inspection Mock Inspection Document Request List Inspection Room Back-Up QPPV 24/7 PV Coverage PV Audit Vendor Audit PV Quality Agreement Escalation PV Regulatory Authority Query Business Continuity PV PV System Description

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)

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 Audit & Inspection ReadinessDocument Request List

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Mock Inspection Inspection Room

Document Request List

Audit & Inspection Readiness

Definition

List of documents requested by inspector at start or during inspection.

Example

Request: last 3 PBRERs, signal log, training matrix.

Regulatory source

GVP Module I

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