FDA Validation For ERP

Life Sciences customers are under extreme pressure to meet regulations while reducing both risk and time to market. ERP validation services from Strategic effectively and efficiently streamline the regulatory compliance process, so manufacturers can focus on what they do best.

Benefits of ERP Validation Process

FDA Validation for ERP provides documented evidence that your ERP solution is configured to meet your defined company processes and official regulatory standards. Validation is required for computer systems used to manage, control, and track the manufacturing and distribution of medical devices and pharmaceutical products. Even though FDA Validation is required, ERP Validation can deliver big business benefits, including: 

ERP Validation Done Better

Strategic has a unique validation method for life sciences companies that manufacture and distribute medical devices and pharmaceutical products. Their approach includes developing a customized Computer System Validation Plan (CSVP). This ensures compliance with federal guidelines and regulations, including ERP software validation as required by the FDA.

Validation Toolkits

  • Computer System Validation Plan
  • Functional Requirements
  • Operational/Performance Qualification Protocol/Test Scripts
    • Distribution 
    • Master Files
    • Manufacturing
    • Risk Analysis
  • Traceability Matrix
  • Baseline Configuration
  • Data Migration Protocol
  • Systems Stress Test Protocol
  • Final Validation Report

Validation Services

  • QAD Documentation Development
  • Guidance and Mentoring Services
  • Execution / Turn-key Services

With Strategic Information Group’s considerable experience in ERP validation, we were able to implement QAD, including validation, in just 90 days.”

Toni C.
Chief Financial Officer, Vita-Tech International

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