The Laboratory Informatics Experts

Computer System Validation (CSV)

Regulated companies like yours are mandated by the FDA, Health Canada, MHRA, EMA and other regulatory bodies to perform Computer Systems Validation. CSV can be complex, time-consuming, costly, and risky.  However, not properly validating your scientific software systems can result in:

  • Warning letters – 483
  • Consent decree(s)
  • Lawsuits / Fines
  • Plant shutdown
  • Indictments
  • Economic instability
  • Staff downsizing
  • Bankruptcy
  • Product recall

How We Can Help with Your CSV

CSols’ CSV consultants are not only validation experts but are also lab informatics experts with extensive real world lab experience.  They understand your science and know what regulatory agencies like the FDA, Health Canada, MHRA, and EMA are looking for when conducting an audit.  CSols, therefore, delivers superior CSV services, reducing your risk while utilizing less of your staff’s time.  Our expertise, experience, and approach will yield you a higher value compared to generic validation consultants and ensures your laboratory informatics systems, instrument systems, and computing environment will be compliant and defensible. Read more…

CSols’ Computer System Validation Services

CSols offers a full portfolio of Computer System Validation Services including:

  • Validation Planning
  • Validation Lifecycle Services
  • Validation Testing and Verification Services
  • Data Integrity Services

Partial list of informatics systems validated by CSols

Benefits From CSols’ Computer System Validation Services

The combination of our knowledge, skills, and processes has delivered fully defensible laboratory informatics and instrument systems as well as peace-of-mind for our clients.

For example:

  1. Risk Assessment MethodSystem Specific Validation Plans – not generic plans that are one size fits all, but plans that truly reflect laboratory informatics CSV best practices based on your intended use and Quality Culture.
  2. On Target Risk Assessments – accurate and informed risk assessments that identify specific functions and features that should be tested and the optimized testing level for each.
  3. Thorough Test Scripts – test scripts that completely exercise your user requirements and specifications with scientific utilization and failure scenarios unique to your intended use.
  4. Detailed Documentation & Reports – clear and concise CSV lifecycle documentation following a GAMP 5 risk-based approach according to software categories throughout your project in a format that will help you pass an audit.

Learn more about Computer System Validation by checking out the white paper below.

 


What’s Next?

If you’d like to talk more about computer system validation for your lab, let’s find a time to chat.

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