Services for GxP Compliance

Ofni Systems provides your business with the highest quality consulting services to meet all of your compliance and quality needs. At Ofni Systems, we believe that compliance adds value to our clients business process. Our primary goal is to ensure that your business meets all of your compliance requirements.

• Our Fortune 500 clients know that Ofni Systems services meet and exceed their exacting compliance standards. These companies appreciate Ofni System’s ability to produce the highest quality results within their existing policies and procedures.
• Mid-sized clients need compliance to add value to their products so that they perform more effectively against their competition. Ofni Systems will quickly and efficiently develop a solution right for you.
• Start-up companies appreciate Ofni System’s ability to quickly deliver solutions to their compliance issues, allowing them to remain focused on their core competencies. Ofni Systems will help you to develop sustainable quality systems, providing the foundation from which you can continue to grow.

Software and Database Validation

Ofni Systems views validation as an opportunity for a business to add value to their computer systems. If you are implementing new systems or trying to bring older systems into compliance, Ofni Systems can validate all of your computer systems and develop appropriate documentation for all phases of the software life cycle.

• Validation Master Plans
• Functional and Design Requirements
• Risk Assessments
• Traceability Matrices
• Installation, Operational and Performance Qualifications

Audits and Audit Preparation

Ofni Systems helps companies review their compliance systems and prepare appropriate remediation plans. In addition to preparing your company for a regulatory audit, Ofni Systems can also help you during an audit, tracking auditor requests and observations.
 

Compliance Assessments

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. Not only can Ofni Systems help with your software, policies and procedures, we can provide your employees with the training to remain in compliance with all applicable regulations.
 

GxP and Compliance Training

Ofni Systems can provide a complete range of training, including Part 11 compliance issues and computer system validation. We can also create training programs to fit your business needs.
 

Data Migration

Ofni Systems can provide assistance with the migration of your existing legacy data to an Access or SQL Server database to simplify using it with a Part 11 compliant Access application. When user access to historical data is important, this solution can provide you with simplified control over all of your data and not just the newer data you may generate.
 

Custom GxP Programming

If your company cannot find an existing system which meets your business requirements. Ofni Systems can develop a Part 11 compliant application to meet your needs. In addition, Ofni Systems can provide the training and support you require to ensure a successful implementation. We also have several general purpose applications, for subjects such as document control and maintaining training records, that may be quickly customized to meet your needs.
 

Program Review

Do you have an Access application that needs updates or must be made Part 11 compliant? Ofni Systems can provide you with support for your existing application, including adding new features or troubleshooting any issues that you are having.
 

Security

We can provide you with Microsoft certified assistance in assessing both the security of your Access applications and databases, SQL Server databases and Windows networks. With over 18 years of experience on Microsoft platforms, we can provide you with the information and services you need to ensure that your data remains secure.
 
Contact us if you have any questions about any of Ofni Systems consulting services or want to know how Ofni Systems can help your company with compliance.