In Reply to Parent Post by hafor
Or according to the FDA's Regulations, what kinds of capability should a traceability system be reached?
For example, should we keep the concession information of raw material in the DMR?
Traceability, as mentioned by MIREMGR is covered by 21 CFR 820 under Sec. 820.65
and states as below -
Each manufacturer of a device that is intended for surgical implant into the body or to support or sustain life and whose failure to perform when properly used in accordance with instructions for use provided in the labeling can be reasonably expected to result in a significant injury to the user shall establish and maintain procedures for identifying with a control number each unit, lot, or batch of finished devices and where appropriate components. The procedures shall facilitate corrective action. Such identification shall be documented in the DHR.
So going back to your earlier question, all concerns with the raw material (incl Material review Board recommendations) should be part of Device History Record (DHR).