The Audit Resource Center (ARC) has been established to be the global central repository to maintain audit information and is based upon PDA's Supplier Audit Process Model. PDA Technical Report No. 32, entilted “Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations” (Revised 2004) describes that auditing process; and, is available through this web site.
Syntegra, a Division of Health Pathways, Inc. (HPI), is the licencee of the PDA developed auditing process and acts as an agent or “Third Party” between client and suppliers. SynTegra's ARC provides online access to a secure audit data repository. Through a partnership with PDA, the Center is designed to enable secure sharing of completed computer products and service audits used by FDA-regulated pharmaceutical and biotechnology manufacturers.
Both product suppliers and manufacturers spend great amounts of time and money on compliance audits. But, most of the time, those audits are simply renewals of work previously done by someone else. The ARC provides a safe, secure center for access to completed audits by subscribers. For a significantly lower investment, a pharmaceutical or biotechnology company can obtain completed audit data from qualified auditors; using the industry-endorsed, standardized process.
The ARC overall purpose, is to provide time and cost benefits to subscribers; accrued from the sharing of information, and reducing duplicative efforts among industry members. The goal is to provide maximum validation benefit to the company, while reducing client risk and cost associated with installation of such technology.
PDA's obligation under the License Agreement with ARC is to establish an Audit Guidance Advisory Board (AGAB) consisting of representatives from PDA, pharmaceutical companies, suppliers, appropriate regulatory agencies. This PDA Advisory Board:
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Periodically analyzes ARC's value to industry and service performance and as necessary furnish ARC with suggestions for improvement.
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Reviews the PDA Audit Process Model and is responsible for ensuring that TR 32 is current with industry needs.
Under existing Advisory Board procedures members serve for three-year terms. Approximately one-third of the AGAB members will be replaced annually. The proposed membership slate is developed to ensure a balanced AGAB membership consistent with the License Agreement. Volunteers are encouraged.