usdatamanagement.com

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.

US Data Management (USDM) consulting professionals are experts in:

• Project Management
• Implementation
• Performing risk assessments
• Vendor selection & auditing
• Compliance and validation services using a best-practices approach that expedites the compliance process and minimizes costs along the way.

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.  Talk to us about our ERP solutions for life sciences.

Examples of ERP systems that USDM has capabilities include:

• SAP
• JD Edwards
• QAD MFG/PRO
• Oracle E-Business Suite
• Microsoft Dynamics (formerly Great Plains)

In addition to hands-on experience in ERP systems, our USDM consulting professionals have in-depth knowledge and expertise in the following:

• FDA regulations (e.g., 21 CFR Parts 11, 210, 211 and 820) 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