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Computer Systems Validation (CSV) 

Computer Systems Validation (CSV) is crucial for all industries governed by FDA regulations. Our expert CSV services guarantee the reliability and accuracy of your operating systems and software, ensuring they consistently deliver the expected outcomes.

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CSV

Ensuring Integrity, Safety, and Quality for FDA-Regulated Industries

Transcat’s CSV services cater to applications in pharmaceuticals, biopharmaceuticals, medical device manufacturing, and diagnostic equipment production, as well as computer systems crucial for safeguarding data integrity, patient safety, and product quality throughout manufacturing processes. Validating the performance of computer systems with Transcat’s assistance can:
  • Ensure data integrity across production, quality control, and distribution systems
  • Mitigate risks in production workflows
  • Uphold compliance with applicable FDA standards

Why Customers Work With Transcat

Transcat’s Solutions team possesses the expertise to validate your computer systems and software, ensuring they meet user requirements and functional specs. We offer a comprehensive suite of solutions designed to facilitate a seamless, reliable, and efficient validation process, including: 

  • Enterprise Systems
  • Infrastructure
  • Automated Equipment and Manufacturing Lines
  • Spreadsheet Validation
  • Data Integrity Evaluations
  • 21 CFR Part 11 Reviews
  • Gap Analysis
  • Remediation
  • Data Tag Modification Procedures
  • Configuration Management Procedures
  • Software Administration Guidelines
  • Periodic Review

To ensure that your computer systems deliver consistent and reproducible outcomes, make validating your computer-based systems a priority today. 

Get in Touch with Our CSV Team Today

Reach out to our team for a consultation regarding your Computer Systems Validation requirements.