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English
$
USD
I will provide pharmaceutical CSV and gmp validation support
China Sourcing and Supplier Research Specialist
I have over 13 years of experience in international trade and working with Chinese suppliers and manufacturers. I help overseas buyers identify suitable suppliers in China based on their product requi...
About this Gig
I provide professional CSV and GMP validation support for pharmaceutical equipment and computerized systems.
My focus is not simply creating documents, but building a clear and risk-based validation approach based on intended use, GxP impact, system risks, traceability and available design information.
I can support:
URS review and GxP assessment
DQ and design verification
Risk assessment / FMEA
FAT, SAT, IQ and OQ strategy and documentation
Requirements Traceability Matrix (RTM)
GAMP 5 based CSV approach
21 CFR Part 11 and data integrity assessment
PLC/HMI and computerized equipment validation
LIMS, MES, QMS and other GxP computerized systems
Support may include document review, gap identification, validation strategy, test design, traceability review, or project-specific validation documentation depending on the agreed scope.
For project-level work, please contact me before ordering. Scope and pricing depend on system complexity, number of requirements, available documentation and required deliverables.
Final project-specific information should be confirmed against the actual system, equipment and approved design documentation.
Business type:
Corporates
•
SMBs
Service type:
General risk assessment
•
Compliance & regulatory
FAQ
What information do you need to start?
Please provide the URS, system/equipment description, available design documents (such as FDS/HDS/SDS), manuals, drawings, existing validation documents, and your required deliverables. The exact inputs depend on the project scope.
Can you support a project if FDS, HDS or SDS is not available?
Yes, depending on the scope. I can work from the URS and available technical information to establish the validation approach. Missing design information will be identified, and project-specific details must be confirmed against the actual system or equipment.
Can you support a complete CSV or GMP validation project?
Yes. I can support validation strategy, URS review, GxP and risk assessment, DQ, FAT, SAT, IQ, OQ, RTM, Part 11 and data integrity activities. Please contact me before ordering because scope and pricing depend on project complexity.
Do you provide generic templates or project-specific validation support?
My main service is professional validation support based on your actual project. I focus on validation logic, GxP impact, risk, traceability and test strategy rather than simply providing generic document templates.
