The FDA and other regulatory bodies require GxP software to be compliant and validated. You want to know your computer systems are reliable. What should you do?
Ofni Systems Validation Methodology
Step 1: Gather Requirements. Document the system functional requirements. Functional Requirements describe what actions the web application must be able to perform. This includes:
- Data to be entered into the application.
- Formulas or calculations performed by each web page.
- Identifying who can enter the data into the application.
- Workflows the application must perform.
- Identify how the system meets applicable regulatory requirements.
Step 2: Document design requirements. Design Requirements describe how the application accomplishes the functional requirements. Ofni Systems uses proprietary tools to analyze the web application 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 application 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.
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. We also identify which aspects of 21 CFR 11 apply to your computer system and how the application 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.
Testing and Qualification Protocols
Once requirements have been outline and documented, the application 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 Web Pages or Web Applications
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 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 web applications make validation simple for you.
Additional Information
Key Benefits of Using Ofni Systems Validation |
