We Provide Following Document as Per Gamp 5 Requirement Initial Risk Assessment
(Ira)
User Requirement Specification (Urs) if Requiredrn
Validation Plan (Vp )
Functional Risk Assessment Document (Ra)
Installation Qualification (Iq)
Operational Qualification (Oq)
Traceability Matrix(Tm)
Validation Summary Report(Vsr)
We Provide various type of services like Hvac(Heating,
ventilation, and air conditioning) Validation
Process Validation
Computer System Validation
21 Cfr Part 11 Compliance
Software Validation Activity
Plc Validation
Scada System Validation
Thermal Validation
Temperature Mapping
Sap Erp Validation
Bms,ems Validation
Spreadsheet Validation
Quality System Documentation (Sop)
Project Qualification
Network Qualification
It Qualification
Compliance Management
Clean Room Validation
As Per Gamp 5 Following Document Shall Be Provided
During Validation Activity : -
Programmable Logic Control System Validation.
User Requirement Specification
Initial Risk Assessment
Validation Plan
Functional Specification
Installation Qualification
Operation Qualification
Performance Qualification
Traceability Matrix
validation Summery Report
Spreadsheet Validation is Required for Pharmaceutical
Industries .now a Day Spreadsheet Validation
Is Essential .following Document Shall Be Provided During Validation Activity :-
User Requirement Specification
Initial Risk Assessment
