ERP Validation Services

VALOIT has multiple consultants capable of working on ERP projects in achieving regulatory compliance objectives. VALOITís ERP validation services include: 

  • Performing quality system analysis 

  • Developing cGXP related quality system requirements 

  • Developing validation documentation, such as validation plans, protocols, test scripts, and reports 

  • Executing validation qualifications (IQ/OQ/PQ) 

  • Providing validation consulting 

  • Performing validation training 

  • Identifying international requirements 

During the implementation of ERP software the finance modules are also done. VALOIT offers consulting services to meet the unique SOX compliance challenges that Life Science companies face. This methodology leverages the existing quality systems companies have developed to comply with FDA regulations to achieve SOX compliance. From planning to operations, the methodology is based on standards set forth by the SEC and IT Governance Board. We assist in supporting client's in achieving compliance with FDA and SEC regulations.

 

Validation 21CFR PART 11 Services Regulatory Compliance Startup & Commissioning
SAP Validation ERP Validation
Training Approach FDA Compliance Training SAP End User Training
Prior to Production Startup Equipment Validation Facilities Validation Computer Validation Services

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