Dirkjan: Created page with "Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design c..."

2020-08-25T07:18:48Z

Created page with "Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design c..."

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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|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|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.
[[Category:fda]]

[[Category:CFR]]

[[Category:CFR 21-820.30]]

[[Category:Design Controls]]

[[Category:FDA]]

[[Category:Quality System Requirements]]

[[Category:Section]]

CFR 21-820.30i - Design Changes - Revision history

Dirkjan: Created page with "Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design c..."