Auditing and Remediation

Minimize risk and make sound business decisions

 

Safis Solutions has an extensive track record providing audits of all types around the world. We perform internal and external audits for a wide range of clients, ranging from startups to the world’s largest pharmaceutical and medical device companies

 

In addition, we have extensive experience assessing deviations and corrective actions such as those articulated in FDA citations and warning letters. Our goal is to provide guidance to our clients, assisting them in meeting the requirements for compliance while maintaining patient safety.

 

quality-auditing-remediation

 

Our Auditing and Remediation Services

 

We provide a full spectrum of auditing and remediation services, including:

 

  • Internal audits to help you monitor and assess your own quality assurance processes
  • External audits of suppliers and vendors to minimize your risk or provide clarity in the selection process
  • Mock auditing/FDA readiness
  • Regulatory inspection preparation and support

     

We inspect a facility in the same way a regulatory body would. As a result, you can rest easy knowing that our experienced staff uses auditing best practices.

 

Remediation may involve services such as:

 

  • Root cause analysis
  • Opening up CAPAs to determine remediation steps
  • Verification of effectiveness for remediation plans

     


Our Auditing Standards

 

Our team audits to applicable and appropriate standards, including:

 

  • ISO 13485
  • Notified Body
  • ISO 14971
  • ISO 15189
  • 21CFR part 820
  • 21CFR part 11
  • 21CFR part 211
  • 21CFR part 212
  • Good Manufacturing Practice (GMP)
  • Good Laboratory Practice (GLP)
  • Good Clinical Practice (GCP)