Case Studies
Safis validates computer system for medical school.
A medical device company calls on Safis to validate software and operating systems.
Validation
Validation clear and simple.
The road to regulatory approval often requires validation. Safis’ validation expertise provides the assurance you need to move from discovery to development and launch with confidence.
Validation services include:
Computer
- Computer network and hardware qualification
- Computer system and software validation
- System testing
Facilities & Equipment
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Facilities Qualification
- HVAC, Water, Air, N2
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Instrument and equipment qualification
- (IQ) installation qualification
- (OQ) operational qualification
- (PQ) performance qualification
- Process validation
Product Validation
- Device
- Diagnostic product
Our validation services include creation of validation master plans, testing services, and unparalleled technical documentation. Additionally, Safis specializes in the validation of software, which 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.