Day

May 31, 2000
31
May

Intersurgical Ltd.

May 31, 2000
Failure to validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70( i). For example, the firm did not validate software for electronic records and electronic signatures. Your written responses dated Feb. 25, April 3, and April 13,2000, stated that you would formalize the policy regarding electronic...
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31
May

FDA CDER Processing an Electronic NDA

May 31, 2000
/docs/ElectronicNDAprocessing.pdf
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Software Risk Management

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Software Verification

IEC 62366 Usability Process and Documentation

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