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Leaders in 21 CFR 11 Compliance and Software Validation Projects, Assessments and Training
Need Validation Help?
Ofni Systems, a leader in MS Access validation, will quickly and efficiently validate all of your MS Access databases and ensure that your databases are compliant with all regulatory requirements.
MS Access is an ideal information management tool for a small company or department. MS Access allows for relatively rapid development and quick implementation with little assistance from IT or other groups. Best of all, most employees already have MS Access installed and do not require additional software for developing their own data management solutions. The FDA and other regulatory bodies allow MS Access programs in GxP environments, as long as these systems are validated and have other technological controls in place to ensure that the database is compliant.
Ofni Systems development team has written dozens of MS Access programs used in GMP, GCP, and GLP environments. (Unlike many development groups, we like MS Access.) Ofni Systems has the technical skill and compliance knowledge to ensure that your database meets all of the requirements of 21 CFR 11 and Annex 11.
As with any computer system, when MS Access is used in GxP environments system, data must be controlled and protected. This includes password protection to ensure only authorized people can access your data, audit trails to track changes to system data, and user-level security to ensure that system users only perform actions they are authorized to do.
If your Access database does not already have the technological tools to be compliant with 21 CFR Part 11, Ofni Systems recommends the Part 11 Toolkit. The Part 11 Toolkit provides MS Access with audit trails, limited system access, password controls, and other technological tools for compliance.
Our validation department has extensive experience validating MS Access databases. We know the potential pitfalls and security holes in Access and have the experience to address them. We have the tools to quickly analyze your MS Access database and generate validation documents that demonstrate that your system is compliant with 21 CFR and Annex 11. This allows us to spend our time efficiently, testing that your database actually performs the functions needed of it and not just generating paperwork.
Validating your Access program means all data can be used to make quality and GxP decisions or submitted to regulatory bodies like the FDA. You can query your data to better understand your business process. You gain confidence in your system and control over the data and who has access to it.
Additional information is available on specific types of validation: