Enterprise Resource Planning (ERP) systems often represent the highest risk area for Life Sciences product manufacturers due to increased integration with shop floor, quality and third-party distribution systems.
Our professionals work closely with client representatives, software engineers and end-users to ensure that requirements (e.g., business, functional and compliance requirements among others) are properly articulated for efficient testing while minimizing execution times and costs.
USDM consulting professionals are experts in:
In addition to hands-on experience in ERP systems, our USDM consulting professionals have in-depth knowledge and expertise in the following:
- International regulations (e.g., 21 CFR Parts 11, 210, 211, 820 and ICH) relevant to ERP systems
- cGXP (i.e., GLP, GCP and GMP)
- Development of validation documentation packages and SOPs
- Execution of validation/qualification protocols and test plans
Rebecca Meledy
888.231.0816 x161
775.213.5943 (fax)
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"Simplify, Unify and Optimize your business & compliance needs with USDM"
