Day

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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Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

office@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN), Canada, and Italy.