Systems Validation
 
Enterprise Resource Planning (ERP)
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.

Tech2Sol consulting professionals are experts in following Services in ERP and Regulations
  • Compliance and Validation Services
  • Project Management
  • Vendor Selection & Auditing
  • 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
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