The FDA and other regulatory bodies require GxP software to be compliant and validated. You want to know your computer systems are reliable and the data stored within those systems is secure. What should you do?

Computer Validation made simple


At Ofni Systems, we will make the computer 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. We also identify which aspects of 21 CFR 11 apply to your computer system and how the computer system addresses those requirements. 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. We will perform risk assessments to determine which areas of the program require the most vigorous testing.

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 System or Database


Validating your system or database 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 computer validation make validation simple for you.

Key Benefits of Using Ofni Systems Validation