Validation

A strength of our  company and a critical factor in  our business success  is our design experience coupled with  computer  systems   validation expertise. Our professionals can help develop and execute the qualification of your system from inception to final production acceptance. The services we offer include the development of: 

  • Validation Master Plans
  • Functional Requirements Specifications
  • Detail Design Specifications
  • Installation Qualification Protocols
  • Operational Qualification Protocols
  • Performance Qualification Protocols
  • Requirements Traceability Matrices
  • Summary Reports

From the plan's inception Valoit listens to the customer and determines the needs and requirements for the proposed project. Design specifications are compared to requirements, and where design specifications may be limited or unavailable, we can retrospectively develop the specification by reverse engineering your system or process. Valoit always works with the customer to ensure that the basic infrastructure to properly implement and maintain a system's validated state is available. We evaluate all information from a regulatory and compliance perspective, then provide quality, practical and cost-effective solutions based on this evaluation. 


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 System Validation

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