FDA Regulated Companies
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Software testing in GxP environments presents its own unique challenges. Organizations that use computer systems validate their systems, but the FDA and other regulatory bodies are requiring that organizations who purchase computer systems for GMP, GLP and GCP environments have verified that the software manufacturer has systems in Quality systems in place to test their software, track software issues and control software release.
Ofni Systems computer testers have experience testing software against all compliance requirements of established regulated companies, including 21 CFR 11, Annex 11 and HIPAA. We understand the distinction between Quality Assurance testing, User Acceptance Testing and Validation testing and make sure that we provide you with the right type and focus of testing. Our specialists are experts in industry validation standards and will produce validation documents which will meet or exceed your exacting standards.
Ofni Systems can test all of your software, databases, web applications, spreadsheets and computer systems, 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.
Ofni Systems uses FastVal to write QA testing and validation documentation and to execute Testing Protocols. This allows us to complete testing and validation projects in 70% less time than traditional methods, with more time spent testing your software and less time preparing documentation. Our goal in all software validation projects is to improve the quality and value of your computer system.
Step 1: Gather User and Functional Requirements.
Document the system functional requirements. Functional Requirements describe what actions the database must be able to perform. This includes:
Step 2: Document Design Specifications.
Design Specifications describe how the database accomplishes the functional requirements. Ofni Systems uses proprietary tools to analyze your system or database 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 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.
Throughout the process, a Traceability Matrix is updated to ensure that all system requirements are addressed. If necessary, a formal risk assessment can be created to document decisions to focus validation testing. A Summary Report is also created at the end of the process to summarize any issues found during the validation project.