ERP Validation

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

ERP Validation Services by Strategic Information Group

ERP Validation 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 Validation is required, ERP Validation can deliver big business benefits, including: 

ERP Validation Done Better

Strategic’s proprietary approach to validating and maintaining qualified technical system environments is specifically designed for life sciences organizations who manufacture and distribute medical devices and pharmaceutical products. Our validation methodology starts by developing a Computer System Validation Plan (CSVP), tailored to your company’s implementation. Ensure you’re always in compliance with federal guidelines and regulations with Strategic’s comprehensive ERP validation approach.

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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