|
|
|
|
|||
|
|
|
||||
|
|
820.40
Document controls.
Each
manufacturer shall establish and maintain procedures to control all documents
that are required by this part. The procedures shall provide for the
following: (a) Document
approval and distribution. Each manufacturer shall designate an
individual(s) to review for adequacy and approve prior to issuance all
documents established to meet the requirements of this part. The approval,
including the date and signature of the individual(s) approving the document,
shall be documented. Documents established to meet the requirements of this
part shall be available at all locations for which they are designated, used,
or otherwise necessary, and all obsolete documents shall be promptly removed
from all points of use or otherwise prevented from unintended use. Interpretation:
This
section refers to all elements of your product’s lifecycle. This includes documents that pertain
to your Quality System Manual to documents that make up your products Device
Master Record (DMR) and Device History File (DHF). It also ensures that all changes are evaluated for safety
and efficacy. In
addition to checking to ensure the documents are readable and formatted
correctly the approval process should be used to ensure that Acceptance
criteria are clearly stated and that the specifications are consistent with
applicable standards and to evaluate the need to revalidate the process.
|
|
|
||
|
|
|
||||
|
Reference: www.FDA.gov The information provided here is for "public consumption" and is open to interpretation. MedicalDeviceSchool.com is not responsible for the content or the accuracy of the information. For all official interpretation and accuracy we ask that you consult the FDA's website directly and that you consult with your legal and regulatory experts on all matters of interpretation. |
|
|
|||
|
|
|
|
|
|
|
