A Quality Agreement (QAG) or Quality Technical Agreement (QTA) between a customer (“contract giver”) and a vendor (“contract acceptor”) has a long history in life science regulations from Contract Manufacturing (CMO) in GMP to Contract Research Organization (CRO) in GCP. Recent (21st century) developments have expanded and extended the requirements for a documented Quality Agreement to vendors that are providing services to regulated companies (e.g., Pharma, Biotech, Med Device).
These agreements are designed as Exhibits to the MSA and cover the quality operation activities predicated by regulations (i.e., QSRs), such as document control, independent quality function, computer validation, CAPA.
Veeva has defined a template which outlines the standard requirements for such an engagement:
Quality Agreement Template (Zipped Word Document)
Please contact your Veeva Account Partner for more information.