Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.
!Attention points
There are two principal administrative elements involved in controlling design changes:
* [[Document Control]]—enumeration of design documents, and tracking their status and revision history.  Throughout this section, the term “document” is used in an inclusive sense to mean all design documents, drawings, and other items of design input or output which characterize the design or some aspect of it.
* [[Change Control]] —enumeration of deficiencies and corrective actions arising from verification and review of the design, and tracking their resolution prior to design transfer.
* The design control system has to be concerned with the creation and revision of documents, as well as the management of finished documents.
* It is important that the design change procedures always include re-verifying and revalidating the design.
** Fortunately, most design changes occur early in the design process, prior to extensive design validation.
*** Thus, for most design changes, a simple inspection is all that is required.
** The later in the development cycle that the change occurs, the more important the validation review becomes.
bag
fda_public
created
Sun, 22 Jul 2012 18:36:13 GMT
creator
dirkjan
modified
Sun, 22 Jul 2012 18:36:13 GMT
modifier
dirkjan
tags
CFR
CFR 21-820.30
Design Controls
FDA
Quality System Requirements
Section
creator
dirkjan