Validation

Move from discovery to development and launch with confidence

 

Validation is an integral part of quality compliance. However, many companies lack the resources required to keep up with demanding validation requirements – or they lack a validation group altogether.

 

Safis Solutions can provide on-site and virtual validation services, working to ensure that your systems and processes are validated in a manner that meets and exceeds regulators’ expectations.

 

auditing-remediation

 

Our validation services

 

We can help ensure your systems and processes comply with FDA GxP regulations by following accepted industry standards such as Good Automated Manufacturing Practices (GAMP). Our validation services include:

 

  • Helping you create validation master plans
  • Organizing validation documentation
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Sterility validation for medical devices, injectables, drug delivery devices
  • Validation of software that is integrated with devices, instrumentation or diagnostics
  • Computer Systems Validation

     

In addition to our product and process validation services, Safis Solutions specializes in the validation of computer hardware and software systems within heavily regulated industries. Learn more about our computer systems validation services »