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Leaders in 21 CFR 11 Compliance and Software Validation Projects, Assessments, and Training
Need Validation Help?
If you have created a series of new e-Forms for the Mi‑Co Mi‑Forms system, the next step is to validate them. The FDA and other regulatory bodies require all GxP software to be compliant and validated. Ofni Systems is partnered with Mi‑Co for validation and will quickly and efficiently assist you with all of your validation needs.
Ofni Systems uses FastVal to write validation documentation and execute Testing Protocols, which allows us to complete validation projects in 70% less time than traditional validation methods.
Our validation professionals have experience in helping large corporations and small companies meet their compliance requirements. Our validation professionals use FastVal to produce high quality documentation, identical to existing company documentation, more rapidly than with a word processor alone. Let Ofni Systems make validating Mi-Co simple for you.
Validating your system or database means all data gathered by the e-Form 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.
Step 1: Gather Requirements. Document the system functional requirements. Functional requirements describe what actions the e‑form must be able to perform. This includes:
Step 2: Document Design Requirements. Design requirements describe how the e‑form accomplishes the functional requirements. Ofni Systems uses proprietary tools to analyze the e‑form to create comprehensive design specifications. Design specifications include:
Step 3: Develop and Execute Test Plans. Once requirements have been outlined and documented, test plans are developed to demonstrate that all required system functionality is met and the system is properly secured. Our validation professionals will document a testing protocol, designed to demonstrate that your form meets all of your business requirements and regulatory requirements outlined by 21 CFR Part 11. As appropriate, this includes operational qualifications (OQ) and performance qualifications (PQ). Deviations, if they exist, will be reported and resolved.
Additional information is available on specific types of validation: