General Electric Inc.

Recipient: General Electric Inc.
Product: X-ray and fluoroscopic systems
Date: 3/31/05

For example, your firm uses electronic database systems to document, track, and control corrective and preventive actions. The Correct Action/Preventive Action System procedure, _____, does not reference the use of these database systems, nor does it describe the steps necessary to close corrective and preventive actions. Also, our inspection found that additions and changes had been made to CAPAs after they had been verified or closed. There are no provisions for this in your procedure.

FDA District: Denver District Office

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