Ofni Systems can help you with all phases of auditing. We recognize that auditing can be one of the most unsettling requirements facing FDA-regulated industries; however, we like to think of auditing as another opportunity to add value to our clients' business. Auditing allows companies to review their internal and external compliance issues in an open and honest manner.

Before a regulatory audit, Ofni Systems can review your internal and external quality systems. Ofni Systems can help your company develop remediation plans to address any compliance gaps. Ofni Systems can also help training your employees to be proactive in dealing with compliance issues.

During regulatory audits, Ofni Systems has proprietary software to help manage audits. Our software can track auditor requests and company responses to auditor observations.

Be Prepared for Audits


Ofni Systems can review your company's policies and procedures against established industry and regulatory standards and assess if your company's actual practices meet those standards. Ofni System identifies gaps during these reviews and can create a remediation plan to address the findings.

Manage GxP Compliance Audits


Ofni Systems uses GxP Auditor to help manage audits. During regulatory audits, GxP Auditor tracks auditor requests, facilitates communication between members of the audit team and produces reports to track the on-going audit.

Audit Responses and Corrective Actions


Ofni Systems can recommend the appropriate responses to audit observations. We can help you determine the appropriate corrective actions and help your company implement changes to your quality systems.