• Global Audits

Vendor Audits-Auditing in the Cloud

Audits are increasingly becoming more relevant in the eyes of the FDA and other agencies. These range from internal audits to external supplier audits (which are growing in intensity each year!). And this includes infrastructure audits that entail Cloud based computing (a relatively new area of compliance). With an aggregate total of over 100 years of combined experience, and an average of 15+ years in regulatory compliance, Quality Assurance, Quality Systems and auditing, USDM’s audit practice team offers an un-paralleled combination of experience and skills across the entire drug development lifecycle from API to Phase I to analytical/stability testing to pivotal trial batches to scale-up, bioequivalence/bioavailability batches, contract manufacturing of investigational medicinal and commercial products.

  • Software vendor audits
    • Audits of technology vendors
    • Audits of cloud vendors

Testimonials

  • 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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