You have created a series of new e-Forms for the Mi‑Co Mi‑Forms system. The FDA and other regulatory bodies require all GxP software to be compliant and validated. Ofni Systems is Mi‑Co’s partner for validation and will quickly and efficiently assist you with all of your validation needs.

Ofni Systems Validation Methodology

Step 1: Gather Requirements. Document the system functional requirements. Functional Requirements describe what actions the e‑form must be able to perform. This includes:

• Worksheets and charts to be included on the e‑form.
• Data to be entered into the e‑form.
• Formulas or calculations used on each e‑form.
• Identifying who can enter the data into the e‑form.
• Identify how the e‑form meets applicable regulatory requirements.

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:

• Inputs - Data entry, validation rules, etc.
• Processing - Workflow enforcement, code, macros, etc.
• Outputs - Reports, data exports, etc.
• Security - User level security, data protection, etc.

Step 3: Develop and Execute Test Plans. Once requirements have been outline 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, plus 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.

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.

Benefits of validating your e-Forms


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 organizations like the FDA. You can query your data to better understand your business process. You also have increased confidence in your form, 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. Ofni Systems is Mi-Co’s partner for validation. 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 Mi-Co make validation simple for you.

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. 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.

Key Benefits of Using Ofni Systems Validation