CHAPTER 23: Data Integrity and Outsourcing Check Access

Outsourcing analytical testing to Contract Manufacturing Organisations or Contact Research Organisations is pervasive throughout the pharmaceutical industry. Indeed, some pharmaceutical companies are virtual with a small number of permanent staff where all work from development, through regulatory submission and manufacturing of the product is outsourced to contract organisations. As part of supplier assessment and on-going monitoring of the work, the CMO/CRO's approach to data integrity is an important consideration as inspection of the contracted work will be undertaken there and not at the sponsor or contract giver's site. A pharmaceutical company (contract giver) must now include requirements for data integrity for the outsourcing organisation (contract acceptor) in quality and/or technical agreements. Moreover, with the emphasis on electronic records generated from the work, where will these be stored and how easily can they be retrieved in case of an audit or inspection? Should a pharmaceutical company just accept a summary report or does due diligence require that the electronic records be reviewed by the contract giver as well? It all depends on the sponsor or contract giver's approach to the management of regulatory and business risk.