Validate Your ERP System With Strategic
FDA Validation For ERP
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:
Ensuring high quality standards are consistently met
Accelerating the production chain
Safeguarding materials processing
Reducing company exposure and risk
ERP Validation Done Better
Strategic has a unique validation method for life sciences companies that manufacture and distribute medical devices and pharmaceutical products. Our risk-based 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 and other international regulatory agencies.
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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
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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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Put Strategic’s ERP validation experts to work for your organization.
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Functional Upgrades
Partner with a trained Strategic expert to evaluate your business processes and find the efficiencies that have been eluding you.
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Managed Support Services - SIGSERV APP
Round the clock support services for complete peace of mind.
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Professional Services
Services from the ERP Pros. From application consulting and validation, to 24/7 ERP support services, Strategic has you covered.