FDA Device Quality System Reg Signature Reqts

The Device Quality System Regulation (GMP) explicitly requires signatures in the following places:
The sections of the regulation which specifically require signatures are:

· Sec. 820.30 Design controls.c & d

· Sec. 820.40 Document controls a & b

· Sec. 820.75 Process validation a

· Sec. 820.80 Receiving, in-process, and finished device acceptance d&e.

· Sec. 820.90 Nonconforming product b

· Sec. 820.120 Device labeling b

The link provided gives the relevant text of these sections with the signature requirement highlighted.

Policy guides and enforcements practices indicate that by interpertation FDA expects signatures on specific records and procedures including any places where company procedures require additional signatures/approvals.

If electronic signatures are used for any of these then since they are signatures required by the predicate rule it is clear Part 11 would also apply for Device Manufacturers.

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.

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