21 CFR Part 11

ולידציה – FRS – Regulatory & HMI Requirements

FRS – Regulatory Requirementscover all the FDA specifications regarding the system compliance with the 21 CFR Part 11 definitions, and also with usual validation documentation demandsHMI Requirementsare intended to provide the URS demands from the HMI screens, regarding proper graphic design and functionality for controlling and monitoring the system, as specified in customer’s contract with the supplier

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ולידציה – URS – Regulatory & HMI Requirements

URS – Regulatory & HMI Requirements cover all the FDA specifications regarding the system compliance with the 21 CFR Part 11 definitions, and also with usual validation documentation demands HMI Requirementscover the provisions demanded from the HMI screens, regarding proper graphic design and functionality for controlling and monitoring the system, as specified in customer’s contract with the supplie

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ולידציה – DQ – Design Review

DQ – Design Qualification is for Design Review by verifying that the system has been designed as specified in the URS -User Requirements Specification, FDS – Functional Design Specification, and relevant equipment specifications satisfying all GMP requirements

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