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Quality Management Systems (ISO, ICH, Annex 11, GAMP 5)

Perhaps the most general of all aspects of Life Sciences, and without a doubt the most prevalent, is Quality Systems. It all starts and ends with quality. From the beginning stages of drug development to the distribution and marketing of a drug or device, quality is imperative! And for USDM, we start and end with quality as well! From our own internal methodologies and methods to our SME’, sales, and management, we exude quality in every part of our company. We do more quality audits and assessments than most other companies in the industry. We stand alone in this area!

Examples of some of our Quality Audits include:

Internal Audits: Quality Control at final release of API, product, containers, devices and even labeling and packaging is absolutely critical in preventing potentially catastrophic contamination or failures in your systems. Internal audits with the help of USDM’s experts can provide a critical set of “fresh eyes” to identify gaps in the processes of new and established systems.

Annual Product Review: The APR of products should have a conclusive summary and oversight of defects, CAPAs, planned and unplanned changes, for example, by the QAU.

Product Complaint: Product complaints can be internally generated within the facility between Packaging, for example, and Manufacturing, and may generate CAPAs which are handled by the QAU. External complaints from customers may enter the system through a completely separate change and should be triaged and treated through escalation levels and include service-level agreements within the organization which may be covered by software systems which USDM may qualify and whose methodology we can provide guidance in validating.

CMC Controls: The scale-up of a drug is inspected by the FDA’s centers as well as field investigators and includes scale-up/pilot batch record review as well as datasets submitted prior to the PAI. USDM has knowledge of the differing requirements in regards to the inspection as well as technical subtleties which the Center may ask before the PAI.

Specific areas include:

  • Internal Audit of Quality Control of Finished Product/Packaging/Labeling System
  • Annual Product Review Assessment
  • Internal Quality System Audits
    • Quality Assurance Unit Development and Check-up
    • Annual Management Reviews/Audits
  • Product Complaint Management
    • Comprehensive External Complaint Response
    • Internal Product Complaint Management
    • Complaint Handling Software Systems: Design, Implementation, Qualification and Commissioning
  • Auditing of CMC Controls, Pivotal Phase 3 Batches & Commercial Scale-Up Programs


  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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