GxP and Compliance Auditing Services

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As the FDA increases regulatory enforcement of 21 CFR 11, one of the most difficult things for many companies is to know what their computer systems require to be in compliance. Ofni Systems can quickly assess all of your software, databases, and computer systems and identify what issues need to be addressed for compliance.

At Ofni Systems, we recognize that an FDA audit can be quite unsettling. However, we like to think of an audit 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. Ofni Systems can help you with all phases of auditing and ensure that you get the most reward out of this valuable tool. Our auditors have worked with large and small companies, in all aspects of FDA-regulated fields from clinical trials to medical devices to biological products to medical imaging to generics.

Be Prepared for Compliance Audits

• Audit Checklists – Ofni Systems can develop tools to facilitate your system review and ensure that your systems meet all applicable regulations.
• Gap Analysis – Before an FDA inspection or regulatory compliance audit, Ofni Systems can review your internal and external quality systems against established industry and regulatory standards and assess if your company’s actual practices meet those standards.
• Remediation Plans – If gap analysis identifies gaps, we can create a remediation plan to address the findings.
• Compliance Training – Ofni Systems can also help training your employees to be proactive in dealing with compliance issues.

Manage FDA Inspections and Compliance Audits

A well-managed audit allows you to maximize the value from the audit, as well as projecting control over all of your Quality systems. Ofni Systems uses proprietary software to help manage audits. Ofni Systems can:

• Track auditor requests and observations, including the status of auditor requests, responses to observations and corrective actions.
• Facilitate communication between members of the audit team
• Produce status reports to monitor the on-going audit and your response to all audit observations.

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.

Supplier Audits

Increasingly, FDA-regulated companies are being asked to verify the compliance of their suppliers. Ofni Systems can assist you with all phases of supplier compliance audits.

If you supply FDA-regulated businesses, we can assess your systems and help you prepare for an audit. Ofni Systems can review your systems and train your personnel to work as suppliers to FDA-regulated companies. Ofni Systems will work to find the best way for your company to meet all regulations applicable to your situation.

If you need your vendors audited, Ofni Systems can provide the expertise to conduct the audits. We can conduct the entire audit independently or include your staff as subject matter experts. We can provide any level of support required, from conducting a single audit to managing your entire audit program.

Benefits of Using Ofni Systems for GxP Audits

• Experience with FDA and GxP requirements – Ofni Systems provides services to companies subject to FDA regulations and are experienced with issues relating to compliance. We can quickly and efficiently review your Quality and regulatory systems and determine if they meet all of your business requirements and regulatory requirements.
• Audit Management Tools designed for GxP environments – Ofni system has proprietary tools, designed to manage FDA inspections and audits.
• Improved Value to Your Quality Systems – Auditing increases the value of your systems and improves the software development process.