REVIEW NEEDED: New GMP Quality Systems Ref Model Draft (1 reply and 1 comment)
Noticed that the file was not attached and am attempting to attach it now.
You can either download the file at the right or click this link - https://edmrefmodel.com/wp-content/uploads/2015/01/DIA-GMP-Quality-Systems-Ref-Model-v24-01-May-2015.xlsx .
We need your help to review the attached draft DIA GMP Quality Systems Reference Model that is intended to be a reference for the artifacts, taxonomy and document properties (metadata) needed to manage documents required for GMP compliance (e.g., SOPs, policies, specifications, methods). Comments are due by June 30th. We appreciate any input you can provide and please share this model with your colleagues in the Quality and Regulatory space to enable us to receive more input from the industry. Instructions are included on the first tab including where to send your comments. The model does not yet represent medical device needs so would appreciate any input on that front as well.
Thanks in advance for your help with this initiative and thanks to the team who participated in meetings over the last 1.5 years to pull together this draft of the model.
Best regards,
Cary Smithson
Associate Director, Information Management
Paragon Solutions | http://www.consultparagon.comยป