Validation clear and simple
Technology used by life sciences companies often requires validation. Safis' validation expertise provides the assurance you need to move from discovery to development and launch with confidence.
How we do it
- IT Network Qualification
- IT Hardware Qualification
- IT System Validation
- Software Validation
- System Testing
Facilities & Equipment:
- Facilities Qualification (HVAC, Water, Air, N2)
- Instrument and Equipment Qualification:
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Process Validation
- Diagnostic Product
Our validation services include creating validation master plans, testing services, and unparalleled technical documentation. Furthermore, Safis specializes in the validation of software that is integrated with devices, instrumentation or diagnostics.
We ensure that your systems and processes comply with FDA GxP regulations by following accepted industry standards, including Good Automated Manufacturing Practices (GAMP).
Safis understands that validation is an integral part of quality compliance and works to ensure that your systems and processes are validated in a manner that exceeds FDA expectations.