Quality Risk Management Findings: Can Regulators Ask to See Them?

Q: Are our quality risk management findings accessible to regulatory agencies? Or are they considered private and confidential company information? A: All quality risk management activities and documentation are accessible to the regulatory authorities. Your company should base its findings on the…

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Does FDA Specify Environmental Conditions for Computer Systems?

Q: Are there FDA guidelines or regulatory requirements for maintaining specific environmental conditions for industrial PCs (HMI, SCADA, DAS, etc.) used in manufacturing operations? If yes, what should be the ideal limits? A: Your question comes from a pharmaceutical perspective but applies…

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