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Ofni Systems is your solution for 21 CFR 11 Compliance
Validation, Assessments, Consultation and Training
Web pages and web applications provide a unique method of sharing applications and information between various sites. This relative ease of accessing information provides a unique set of challenges in validating these systems for GxP use. Ofni Systems validation specialists have experience working within the compliance requirements of established regulated companies. Our specialists are experts in industry validation standards and will produce validation documents which will meet or exceed your exacting standards.
Ofni Systems can validate all of your web pages and web applications, and develop the appropriate documentation for all phases of the software life cycle. We can provide any level of service required, from executing test scripts generated from your existing specifications to writing the entire validation package. Ofni Systems will perform risk assessments to focus the validation effort on the most appropriate sections of your system.
Step 1: Gather Requirements. Document the system functional requirements. Functional Requirements describe what actions the web application must be able to perform. This includes:
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:
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.
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.
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 is available on specific types of validation: