Companies who supply computer products and services (suppliers) to pharmaceutical companies (manufacturers) are required, by regulation or good business practices, to audit their performance. PDA Technical Report No. 32: Auditing of Suppliers Providing Computer Products and Services for Regulated Pharmaceutical Operations (TR-32) defines a six-step process for performing such an audit. Each of the steps represents a collection of activities to be accomplished by qualified auditors, manufacturers, and suppliers.

TR-32 followed in the aftermath of the U.S. Food and Drug Administration's (FDA's) appeal to the regulated industry to standardize the auditing process for suppliers of computer products and services and establish a global repository for sharing audit information. The issues that concerned FDA included:

1. Uncertainty: Without an objective standard for all suppliers to follow, the obvious dilemma is that a supplier can never be reasonably certain that they are in compliance.
   
2. Inconsistency: Unless the objective standard is applied uniformly, from company to company, it is fair to say that all companies are not being treated alike. Some companies are more in compliance, while others are less compliant.
   
3. Redundancy: Because a supplier is often requested to submit to audits by a number of client manufacturers, a global repository makes sense since it would avoid a duplicative process.
   
4. Cost: Survey data at the time suggested that the beginning to close-out cost, per audit, was approximately $8,000 to $10,000 each to the manufacturer and the supplier. A global repository would reduce spiraling costs since suppliers are often audited several times in one year.

As a result of FDA's concerns, PDA issued TR-32 in January of 2000 to serve as a model for suppliers providing computer products and services for regulated pharmaceutical operations. The following year PDA licensed The Audit Repository Center (ARC) to serve as the global repository for all of its audits. ARC stores, then makes available via the Internet, the various audits submitted by suppliers. This allows manufacturing companies (subscribers) or participating suppliers to obtain easy access to the data.

To learn more about the Audit Repository Center, or, to subscribe to the growing number of audits available in ARC's Repository, visit www.auditcenter.com.