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.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
Partners located in the US (CA, FL, MA, MN) and Italy.