Part 11 Software and Solutions Providers

For a partial list of software and services vendors that are aware of Part 11 and claim to provide Part 11 packages or solutions at the link provided.

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Other SoftwareCPR Keywords: 21 CFR 11, Part 11, Electronic Records

Software Verification

Do you have gaps with IEC 62304 compliance or with FDA expectations for software verification?  We can help you quickly remediate gaps with unit verification including unit testing, code review, and static analysis, as well as integration and system verification testing.  Call us at 781-721-2921 or email office@softwarecpr.com to start a conversation.  We can provide estimates of cost and support your development tools.

Corporate Office

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