Abstract
One approach used by organizations to reduce cost and improve quality is to leverage the expertise of product and service providers as an alternative to building equivalent capabilities in-house. Indeed, outsourcing and partnerships with external service organizations and software vendors have become strategic initiatives in most organizations’ plans. When looking at the pharmaceutical industry, we can see a chain of service providers, some of which also serve other providers. For example, Contract Research Organizations (CROs) serve the pharmaceutical company; an Application Service Provider (ASP) serves both the pharmaceutical company and the CRO; and a software vendor serves all three. For this approach to succeed, certain levels of quality, control, integrity, and trust must be maintained throughout these relationships. Partnerships, in which expectations of all parties are set and quality measures can be established and inspected, are essential for meeting business and regulatory objectives.

A vendor audit is the vehicle used to inspect and evaluate a vendor’s quality management system, practices, and documentation. The need to conduct such vendor audits and inspect a vendor’s quality practices has been recognized by the industry for several years now. However, many of these audits are driven by lengthy checklists of questions and resulting scores which auditors try to apply to any type of vendor, regardless of the products or service that they provide. In other cases, even when the checklist is customized to the vendor, the audit is focused on simply mechanically filling out the blanks and ranking, instead of working with the vendor to understand what is done right (and wrong), and how to mitigate risks where gaps are identified.

The objective of this white paper is to set forth auditing considerations that will better enable auditors to perform the necessary due diligence to minimize risk of quality issues and  noncompliance when dealing with the computer systems used by external partners such as CROs, Contract Manufacturing Organizations (CMO), Contract Laboratories, application service providers (ASP), and critical suppliers.

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