Services and Solutions for Electronic Record 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 processes. Our primary goal is to ensure that your business meets all of your compliance requirements.

Contact Us To Learn More About Our Validation Services

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.

Audits and Audit Preparation

Ofni Systems helps companies review their compliance systems and prepare any needed 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 determining what is needed for their computer systems to be in compliance. Ofni Systems can quickly assess all of your software, databases, and computer systems to 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 applicable regulations.

GxP and Compliance Training

Ofni Systems can provide a complete range of training, including Part 11 compliance 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 simplified control over all of your data and not just newly-generated data.

Custom GxP Programming

If your company cannot find an existing system that 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 successful implementation. We also have several general purpose applications for functions such as document control and maintaining training records that may be quickly customized to meet your needs.

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.