USDM performed a detailed assessment of all systems determined by client to be GxP compliant and reduced the number of systems in the client’s original scope by over 80%
We 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 client during the project and initially out of scope.
- Team of highly skilled Sr. Consultants, onsite and remote testers and technical writers produced further cost savings.
- Performed Audit Readiness Training to prepare Client teams in Quality, IT and the business.