USDM performed a detailed assessment of all systems determined by customer to be GxP compliant and reduced the number of systems in the customer's original scope by over 80%.
USDM ensured that proper justification was in alignment with both customer SOPs and global regulatory guidelines, leveraged existing documents wherever possible and developed a streamlined risk program.
- USDM managed the program and remediated 287 systems – including 86 that were identified by the customer during the project and initially out of scope
- Team of highly skilled senior consultants, onsite and remote testers, and technical writers created critical efficiencies while reducing costs
- Conducted Audit Readiness Training for quality and IT teams