GMP Quality Ref Model

Back to GMP Quality Ref Model...

Need Comments on Draft Model by July 31st (No replies)

carysmithson
3 years ago
carysmithson 3 years ago

We need your help to review the draft of the new DIA GMP Quality Systems Reference Model linked here (http://edmrefmodel.com/wp-content/uploads/2015/01/DIA-GMP-Quality-Systems-Ref-Model-v24-01-May-2015.xlsx ) that is intended to be a reference for the artifacts, organization and document properties (metadata) needed to manage documents required for GMP compliance (e.g., SOPs, policies, specifications, methods, etc.).

This model is a reference for the life sciences industry and should not be considered mandatory, but rather as an opportunity for standardization across the industry to enable greater interoperability and simplify business process hand-offs among sponsors, business partners, and suppliers / service providers (e.g., contract manufacturers) related to GMP documents and content required for compliance.

Comments are due by July 31st and we expect your review to only take a couple hours. Feel free to only comment on the section of the model that applies to your work and experience.

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.