is being presented by Dan O'Leary, President, with Ombu Enterprises and airs on Thursday, May 26th, 2011. For more details, or to register for this event please visit our site at www.fxconferences.com
The Device Master Record (DMR) and the Device History Record (DHR) serve to document your manufacturing process and the results, and also to assist in solving problems. Equally important, your DMR and DRH must align, and during an FDA inspection the investigator will check to make sure they do! Now is the time to understand, before you have to explain in a 483 response.
The DMR and DHR are part of four related documents that are important to your QMS. During design, you will create a Design History File (DHF) documenting how you developed the design and moved it to production. One of the major design outputs is the Device Master Record (DMR). However, you can put some of the information into the Quality System Record (QSR), which you must also create.
This audio conference presentation discusses the difference between the DMR and the QSR, and how to organize your information. While focusing on the DMR and DHR, the speaker also provides a roadmap for understanding the interlocking relationship among all four critical records. With this knowledge, you can ensure your QMS is efficient, effective, and compliant.
