Turnkey Validations
The Validation Service Team conducts a fully documented validation project with minimal impact to organization’s resources. IQS brings its own resources, focused on accomplishing the task of validating the system and providing all the necessary outputs and documentation. Whenever possible, we employ a risk based approach to validation that analyzes the software, process or system to identify and rate each potential risk in order to design the optimal validation solution. This approach can be applied to almost any validation requirement and provides a justification for focused validation testing that verifies critical functionality and minimizes the time spent on elements that present little to no risk.
Our experts can help you define your critical processes and implement a validation solution that meets your exact needs.
Outputs of a validation can include, amongst others;
User Requirements Specifications (URS)
Functional Requirements Specifications (FRS)
Software Requirements Specifications (SRS)
Part 11 Gap Analysis
Risk Assessments
Factory and Site Acceptance Tests (FAT & SAT)
Validation Master Plans
Installation Qualifications (IQ)
Operational Qualifications (OQ)
Performance Qualifications (PQ)
Data Security and Control Verification
Standard Operating Procedures (SOP)