Validation Services

Do you require leadership, support or execution in any of these areas?

Deliverable	Typical Automation Supplier Role	Can a consulting or execution role help your program?
Master Validation Plan	None
Equipment Validation Plan	None
User Requirements Specification	None, Customer Document
Functional Specification	Provide FS Summary Table as part of Proposal
Full Requirements Traceability	Typically only to show completion of requirements from the URS-FS-DS-FAT/SAT
Process QFD and Control Plans	Typically None
Formal Process FMEA	Supports
Documented Design Reviews and formal DQ Activity with mitigation traceability	Supports
System Design Specification	Provides
Process Optimization Testing prior to Validation	Supports
FAT/SAT & Related Reports	Supports
IQ/OQ & Reports	Supports
PQ	Supports