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Computer Systems Validation (CSV)

Computer System Validation (CSV) is a fundamental part of FDA-regulated industries, ensuring that accuracy and consistency of operating systems and software will produce expected results.  To maintain confidence in pharmaceutical, biopharmaceutical, medical device manufacturing, and diagnostic equipment manufacturing applications, computer systems involved in controlling data integrity, patient safety, and product quality within the manufacturing processes require validation. 

The NEXA team has the expertise and extensive range of solutions to confirm your computer systems and software are operating according to user requirements and functional specifications.

  • Enterprise Systems 

  • Infrastructure 

  • Automated Equipment and Manufacturing Lines 

  • Spreadsheet Validation 

  • Data Integrity Assessments 

  • 21 CFR Part 11 Assessments 

  • Gap Analysis 

  • Remediation 

  • Data Tag Modification Procedures 

  • Configuration Management Procedures 

  • Software Administration Procedures 

  • Periodic Review 

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We specialize in all aspects of CSV, including:

To make sure your computer systems maintain consistent and reproducible results, prioritize validating your computer-based system today. 

Contact our team for a consultation to discuss your Computer Systems Validation needs.

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