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Validation - Coggle Diagram
Validation
VMP
Request Form :check:
Changes required
Agree structure of document
Preamble
Why we validate
Regulatory expectations
Overview of validation processes from URS to RTM
Pick up all the terms and put them in context of this site
GAMP 5 Overview
Risk-based approach to validation
FMEA
HACCP
Maintaining a validated state
Tracker and dashboard
Issuance or periodic requalification forms
List of all items and activities to be reviewed
Curium's approach to Validation
Documentation
Principles
Witnessing (external)
ALCOA+ principles
Evidence and attachments
Vendor activities - protocols must be reviewed pre-approved
Pre-approval of documentation
Having draft for validation SOPs in place first (where applicable before performing PQ)
Templates
RTM
VSR
PQ
OQ
IQ
DQ
URS
Simplified
Standard
VP
Periodic review / Requalification
Major Project
Minor Project
Identify all aspects to be captured in VMP
Final Documents Bundle
QMS-VMP-001 (Validation Master Plan)
Validation Schedule
QMS-SOP-055 (Validation Approaches)
Various blank templates
Template for Analytical Method Validation
Template for Temparture Mapping
Process Validation
Analytical Method Verification
Update EQP-FRM-030