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