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cGMP – DESIGN AND DEVELOPMENT TRANSFER (DMR) (11)

Rami.Azulay November 6th, 2019 Posted by Rami Azulay( ) Requirements Management Tool

The Device Master Record (DMR) is the ultimate document for ensuring efficient design transfer. It is not a mandatory requirement according to ISO 13485. The DMR is mostly theoretical as it is a compilation of documents required to complete the design process. The documents consist of all the documents above and the validation master plan.

DMROrcanos DMR system

In time, the document will need revising and subject to change. The DMR will help index each document as well as their note their current revision. To achieve a successful design transfer, you need the DMR. The transfer could be an internal transfer, manufacturing, or involving a customer manufacturing organization (CMO).

There are several ways to capture the design transfer process. They are;

  • A transfer checklist
  • A checklist that forms a part of the product’s lifecycle SOP.
  • An entirely new form.

The checklist comprises of activities to complete to aid a successful design transfer.  The list will include the following;

  • Facility preparedness
  • Product specification
  • Training activities
  • Test method
  • Component properties
  • SOPs and WIs
  • Success criteria

Also, the design transfer process comes with a design transfer plan with well-defined criteria. A report should be made available upon completion. The report will contain all the activities and proof a successful transfer.


About the author, Rami Azulay

Rami has over 24 years of experience in various software development and QA roles. Using his extensive knowledge of operations and quality, Rami was a main architect of the Orcanos software back in 2005 and later became Orcanos VP sales & marketing. Rami holds an MSC degree in Computer Sciences.

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