H
I want to add a serial cable to my Mark10 BG50 Force Gauge and a computer with software (MS Excel) to assist in capturing, charting, analyzing, and trending the data from pouch and tray seal pull tests. Under FDA QSR21 CFR 820.70 subpart G - Production and Process Controls, "When computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate the computer software for its intended use according to established protocol".
My questions: Does my using a computer and Excel to capture and chart pull tests meet the FDA requirement? If you believe the answer is yes, can you recommend a source for information to learn how to validate my software and process? Can you offer any insight in how your organization handles this type of situation?
Thanks!
My questions: Does my using a computer and Excel to capture and chart pull tests meet the FDA requirement? If you believe the answer is yes, can you recommend a source for information to learn how to validate my software and process? Can you offer any insight in how your organization handles this type of situation?
Thanks!

