Our comprehensive suite of Computer Systems Validation services helps you keep your regulatory operations fully automated and fully compliant with FDA’s 21 CFR Part 11 and industry best practices such as GAMP.

Services include:

• Computer Systems Validation
  •  Full validation of any system
• Revalidations
  • Risk-based analysis of system changes to determine regulatory impacts
•  Validation Gap Analysis
  • On-site audit of existing validation approach to identify gaps in compliance
•  Validation Staffing
  • Experienced resources that seamlessly integrate with your validation teams to enhance results and shorten project time
•  Regulatory Consulting, Training, Documentation and Support Activities
  • For PDMA, 21 CFR Part 11, DEA, cGxP, VAWD, Cold Chain, and State requirements

We provide validations for:

• SFA/CRM systems
• Life Sciences support systems and applications, including sampling and order/warehouse management systems
• Clinical and medical device support systems