Compliance

Compliance

Scilife's Validation Approach

We perform 95% of validation activity!

Scilife uses a system validation approach according to GAMP5 and 21 CFR part 11, assuring full integration of software life cycle management and risk management activities. We take care of 95% of the validation activity, saving you from redundant tasks and preserving your valuable resources. All you need to do is evaluate the suitability of Scilife's software and pinpoint any additional efforts necessary for your specific application and intended use.

Start With Our Comprehensive
Validation Package

Our validation package lays the groundwork for your required documentation. The comprehensive GAMP5 validation documentation package we provide includes:

1. Validation Plan
2. URS
3. Risk Assessment 
4. Configuration Specifications 
5. Test Plan 
6. Installation and Operational Qualification 
7. Performance Qualification
8. Traceability Matrix
9. Test Summary Report 
10. Validation Summary Report