Validation Service

URS: Validation plan e.g. risk assessment, assessment of components, supplier assessment (audit)…
FRS: Quality & Project Plan, Design Reviews,…
DS: Hardware Design Specification, Mechanical & Electrical Specifications, Design Reviews (e.g. traceability matrix),…
RS: Identifications Specifications, Components, Equipment, Procedures…
Construction: Constructions Reviews, Hardware Manufacture & Assembly
HW Testing: Supplier IQ, OQ, PQ (Factory Acceptance Testing = FAT)
IQ: Hardware Installation, Equipment Installation, HW Acceptance Testing
SAT: Machine Performance, OQ, PQ
Maintenance Change Control: SOP’s, Maintaining Validation State (Operational Plan & Procedure, Training, Backup/Recovery…), Validation Report