MS Access is an ideal information management tool for a small company or department. Access makes it easy to develop and maintain databases. The FDA and other regulatory bodies require GxP software to be compliant and validated. However, MS Access does not natively have the technological tools such as audit trails or electronic signatures to be compliant with 21 CFR Part 11. What should you do?

MS Access Validation made simple


At Ofni Systems, we will make the validation process simple for you. The first step in the validation process is to identify key system requirements for your program. This includes identifying critical work-flows and security user groups. These requirements will be used to develop user specification requirements (URS), functional requirements specifications (FS or FRS) or software design specifications (DS or SDS) depending on your company requirements.

Compliance with 21 CFR 11


A key system requirement is compliance with 21 CFR Part 11. If your Access database does not already have the technological tools to be compliant with 21 CFR Part 11, we recommend the Part 11 Toolkit, which provides MS Access with audit trails, limited system access, password controls and other technological tools.

Testing and Qualification Protocols


Once requirements have been outline and documented, the software is tested. Our validation professionals will document a testing protocol, designed to demonstrate that your system meets all of your business requirements, plus regulatory requirements outlined by 21 CFR Part 11. As appropriate, this includes installation qualifications (IQ), operational qualifications (OQ) and performance qualifications (PQ). Deviations, if they exist, will be reported and resolved.

Benefits of validating your MS Access database


Validating your Access program means all data can be used to make quality and GxP decisions or submitted to regulatory organizations like the FDA. You can query your data to better understand your business process. You also have increased confidence in your system, control over the data and who has access to that information.

Benefits of Using Ofni Systems

Ofni Systems will quickly and efficiently assist you with all of your validation needs. Our validation professionals have the experience in helping large corporations and small companies meet their compliance requirements. Our validation professionals use FastVal to produce higher quality documentation identical to existing company documentation more rapidly than with a word processor alone. Let Ofni Systems' experience with validating MS Access databases make validation simple for you.

Key Benefits of Using Ofni Systems Validation