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


USDM revamps antiquated auditing process to save customer’s time and money

To eliminate regulatory exposure for vendor and supplier relationships, the customer engaged USDM to provide regulatory expertise for vendor audits and qualification throughout the United States and world.


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

To support the customer’s efforts as new markets emerged, the number of required vendors grew. The customer’s internal resources weren’t able to keep up with the variety of audit types. Further, some of the vendors required last-minute audits that could not be fulfilled by the customer’s resources.

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) who had vast and diversified experience in auditing according to agency regulations.
  • USDM conducted in-depth studies to explore the entire manufacturing lifecycle and understand the core products manufactured by the customer, 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 has templates and standards in place, but the team was required to comply with customer processes.

  • 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.
  • 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 initial email to vendor, date of audit, date of audit report, response from vendor, and issuance of 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 and 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

  • 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, the safety and efficacy of the products manufactured, and the products used by patients worldwide. The services delivered by USDM receive high-level visibility because the audits touch on the entire manufacturing supply chain in the company.
  • Culture: The shift from performing vendor and supplier audits solely with internal resources to trusting USDM meant that USDM needed to understand the customer’s corporate processes and procedures. Communication was key to a successful cultural change. USDM instituted regularly scheduled one-on-one meetings with the customer that helped build the trusted customer-consultant partnership.
  • Action: The customer realized ~25% improvement in auditing compliance by having USDM conduct these audits and follow up directly with the 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. The customer considers USDM an extension of their own auditing department. For the vendors, each report developed by USDM is a report from the customer.

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