Vedant Tech Services

Control System Validation

PLC/HMI/IPC based control system
Supervisory Control and Data Acquisition (SCADA) system
Medical Devices Instrument and Software (ISO13485)
Data Acquisition System (DAS)
BMS System and DCS System
Database Systems including ERP such as SAP & LIMS
IT & Network Qualification.

Our Approach for Computer System Validation

Validation Master Plan (One Time)
Gap Assessmet (GAP)
Initial Risk Assessment (IRA)
21CFR Part 11 compliance services (Where ever applicable)
User Requirement Specification (URS) If Required
Validation Plan (VP) Qualification Protocol Preparation and execution.
Functional Specification (FS) If Required

Design Specification (DS)If Required
Functional Risk Assessment Document (RA)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Traceability Matrix (TM)
Validation Summary Report (VSR)

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