Auditing-as-a-Service Delivered 80% More Efficient Audits

The Challenge

A leading global biotechnology company that drives innovations for complex diseases relied on hundreds of vendors that were critical to the overall development and worldwide distribution of a blockbuster drug. However, the company didn't have the bandwidth to comply with regulatory requirements for vendor qualifications.

As new markets emerged, the number of required vendors grew, and the customer's internal resources couldn't keep up with the variety of audit types. Some vendors required last-minute audits that the customer's own teams simply could not fulfill. Without a scalable program, every gap in vendor qualification represented potential regulatory exposure and a risk to the products patients depend on. Managing this kind of supplier risk at scale is exactly where third-party risk management becomes mission critical.

The Approach

To conduct and follow up on global vendor and supplier audits, USDM established a partnership with the customer to execute the auditing process on their behalf.

• USDM assessed the types of vendors required to be qualified.
• USDM assembled a team of highly qualified subject matter experts (SMEs) with vast, diversified experience auditing according to agency regulations.
• USDM conducted in-depth studies to explore the entire manufacturing lifecycle and understand the core products the customer manufactures, from raw materials to final distribution and release.
• USDM requested product profiles, reviews of previous audit reports, and associated documentation.

The Joint Solution

USDM has performed hundreds of vendor qualifications for other customers and brought proven templates and standards to the engagement—but the team was required to comply with the customer's own processes from day one. Disciplined documentation and traceability anchored the program, reflecting USDM's broader commitment to data integrity in life sciences.

• The USDM team was trained on the customer's standard operating procedures (SOPs) directly related to the auditing standards.
• The USDM team documented the training for potential U.S. Food and Drug Administration (FDA) inspections at the customer site, keeping the program audit-ready in line with 21 CFR Part 11 expectations.
• The USDM team put in place a tracking system—approved and adopted by the customer—to track each audit from identification to execution to final closure. Items tracked included the initial email to the vendor, date of audit, date of audit report, response from vendor, and issuance of the closure letter to the vendor.
• The USDM team was trained on the customer's Quality Management System (QMS) and given access to the customer's email system. Over time, the USDM team became a trusted partner that handled more of the overall auditing process and dealt directly with the vendors. Now, the customer simply tells USDM which vendors need to be audited per current processes, and USDM handles the logistics.

The Results

By making vendor auditing a managed service rather than an internal scramble, the customer turned a chronic bottleneck into a repeatable, measurable program.

• The customer improved its reporting accuracy.
• The customer saw an 80% decrease in auditing time.
• The customer saves $112k annually.

High-Impact Outcomes

• Visibility: Vendor audits are critical to the customer's procedures and to the safety and efficacy of the products patients use worldwide. Because the audits touch the entire manufacturing supply chain, the services USDM delivers receive high-level visibility across the company.
• Culture: Shifting from internal-only audits to trusting USDM meant USDM had to understand the customer's corporate processes and procedures. Communication drove a successful cultural change—USDM instituted regularly scheduled one-on-one meetings that built a trusted customer-consultant partnership.
• Action: The customer realized a ~25% improvement in auditing compliance by having USDM conduct these audits and follow up directly with vendors for audit closure. USDM helped the customer save thousands of dollars in the external auditing practice by improving the efficiency and effectiveness of each audit performed.

Key Learnings

The customer learned that USDM is a trusted partner with outstanding services and deliverables and now considers USDM an extension of its own auditing department. For the vendors, every report USDM develops is, in effect, a report from the customer. Treating vendor auditing as an ongoing program rather than a one-off event is the foundation of continuous compliance—and the reason the customer gained both speed and confidence.

The bottom line: USDM's Auditing-as-a-Service model delivered 80% faster audits, ~$112k in annual savings, and roughly 25% better compliance—while removing a persistent operational burden from the customer's internal teams.