Computer Systems Validation Consulting and Outsourcing

Developing and bringing to market life-changing drugs and devices: that’s your job. Expert computer systems validation consulting: that’s ours. You have enough to accomplish, let us be your resource for computer systems validation. As a global leader specialized in computer systems validation consulting services, PSC Biotech works to ensure life sciences companies’ processes are functional and in full compliance with FDA and EMA guidelines. With over two decades of consulting experience in the life science industry, we fully understand that computer systems are a key element of a company’s success, so we guarantee these systems are running efficiently and accurately when you work with PSC Biotech.

Our CSV Services

When you work with PSC Biotech, you can expect a seamless, FDA and EMA compliant, customized solution to all your computer systems validation needs. With over two decades of consulting experience in the life science industry, we fully understand that computer systems are a key element of a company’s success. Our specific areas of expertise within computer systems validation are included below.

  • Enterprise resource planning systems
  • Electronic document management systems
  • 21 CFR Part 11 assessments, remediation & training
  • Facility management
  • Environmental controls
  • Heating, ventilation & air conditioning
  • Laboratory equipment
  • Clinical data management systems
  • Adverse events systems
  • Laboratory information management systems
  • Material requirement planning systems
  • Manufacturing execution systems
  • Calibration management software implementation and validation
  • Plant maintenance & asset management system implementation and validation
  • Quality management systems