DIA GMP Quality Systems Reference Model v1.0

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DIA GMP Quality Systems Reference Model v1.0


This is the 1.0 version of the DIA GMP Quality Systems Reference Model that includes DIA branding and is in process of being uploaded to their public website.

What is the DIA GMP Quality Systems Reference Model?

The Drug Information Association (DIA) GMP model provides a reference for the documents (artifacts) and metadata that are typically needed to implement leading practice solutions and business processes for managing the GMP Quality Systems documentation required for regulatory compliance at biopharmaceutical companies.

It is a reference for the Life Science industry and should not be considered mandatory, but rather as an opportunity for standardization across the industry for greater interoperability and simplified business process hand-offs among sponsors, business partners, suppliers and service providers related to GMP documents and content required for compliance.

How to Use the GMP Model?

To use this model, compare the artifacts and metadata to what you need for your company's GMP quality documentation business processes, decide which artifacts and metadata you will use / not use, and add artifacts and metadata as needed.  Look for software vendors and consulting firms who use this model as a starting point to help their clients organize their compliance documents.

About carysmithson

With 25 years of experience in management, quality, regulatory and IT consulting focused on content / information management, Cary Smithson has led increasingly complex programs and projects, provided business, regulatory and technical expertise and consistently delivered results for clients in the life science and healthcare industries.
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