COMPUTER SYSTEM VALIDATION TRAINING IN MUMBAI

Training on End to End CSV
Introduction to CSV
Introduction to GAMP5
GAMP 3,4,5, System categories & Validation methodology
VMP - Validation Master Plan -
GAP Assessment-
URS -User requirement specification-
Initial Risk Assessment-
Vendor Assessment-
21 cfr part 11 Assessment-
Validation Plan-
FCS - Functional configuration specification-
QRM -Quality Risk Management -
Risk Acceptance & Risk Management -
IQ- Installation Qualification-
OQ -Operational Qualification-
pq -Performance Qualification-
Discrepancy reports-
TM -Tracebility Matrix-
VSR-Validation Summary report-
System Retirement-
System Revalidation /Periodic review-
Test Plans/Test Protocols-

Services
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Computer System Validation
Software Validation
Spreadsheet validation
Cleaning Validation
Web application Validation
Data Integrity,ALCOA+
Medical Devices 510k
IT-Auditing (Internal/External)
Calibration medical devices

SOP Templates available
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VMP - Validation Master Plan -
GAP Assessment-
URS -User requirement specification-
Initial Risk Assessment-
Vendor Assessment-
21 cfr part 11 Assessment-
Validation Plan-
FCS - Functional configuration specification-
QRM -Quality Risk Management -
Risk Acceptance & Risk Management -
IQ- Installation Qualification-
OQ -Operational Qualification-
pq -Performance Qualification-
Discrepancy reports-
TM -Tracebility Matrix-
VSR-Validation Summary report-
System Retirement-
System Revalidation /Periodic review-
Test Plans/Test Protocols-