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It is not always necessary to replace your legacy systems to comply with current regulations…

The “Wrap & Comply” concept looks at working with your current system components to minimize your validation effort.  Maximizing the re-use of hardware and software will enable you to “Wrap” your legacy system in a compliant architecture in order for the GxP system to “Comply” with regulatory requirements including the FDA’s 21 CFR Part 11.

Save time and money…

  • Re-use existing hardware
  • Re-use existing software
  • Minimize SOPs
  • Improve plant efficiency and quality
  • Faster time to market
  • Reduce validation

Let us help you identify the non-compliant systems and take the necessary remediation action to validate them:

  • Gap analysis – Identify computer system validation gaps
  • Coverage Assessment – Determine which GxP rules must be satisfied
  • Risk Assessment – Determine and prioritize potential compliance actions
  • Mitigation/Remediation Plan – Formulate a corrective action plan addressing the deficiencies following the rule: “Maintain as much of the existing hardware and software as possible”
  • Implementation – Implement corrective actions

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