Boston Scientific Details Centralized Audit Support System

When Boston Scientific’s manufacturing operations recently underwent third-party verification audits, the firm used a companywide audit support operation that linked multiple production sites electronically to help manage the inspections process.

The goal of the inspection support system was to provide sites with consistent, accurate and timely information, as well as strategic support, Stephanie Gray, director of corporate compliance strategy, said.

“Sometimes when you’re watching something as an observer, you can kind of tell where it’s headed more than someone right in the middle of it,” Gray said at the Second Annual FDA Inspections Summit.

The third-party audits were conducted at 23 sites located in areas from Europe to California. The audits are part of the company’s plan to address an FDA corporate warning letter that cited Boston Scientific for quality system violations. The firm expects to meet with the agency during the fourth quarter when it is ready for reinspection.

The audit system included an internal corporate website so individual manufacturing sites could better prepare for the inspection and learn best practices from other sites, Gray said. Every item that could conceivably be asked for by an auditor or items previously requested were posted to the website.