Computer Software Validation

Computer Software Validation is a formalized, documented process for testing computer software and systems, required by 21 CFR 11.10(a) and Annex 11, Section 4. The FDA and other regulatory bodies require validation to demonstrate that computer systems are in compliance with all regulations for electronic data management systems. Failure to validate systems is one of the leading reasons a business is issued a 483.

Ofni Systems can validate all of your software, databases, spreadsheets, and computer systems, and develop the appropriate documentation for all phases of the software life cycle. We have written (and executed) commercially available validation packages. We can provide any level of service required, from executing test scripts generated from your existing specifications to writing the entire validation package. We can follow your existing validation procedures or provide your company with validation standards. Our validation methodology ensures validation deliverables that exceed your highest standards, focus resources towards the most critical system functions, and complete the validation projects in less time (and money).

Improve the Quality and Value of your Systems

Ofni Systems’ goal in all software validation projects is to improve the quality, value, and compliance of your computer system. We use our proprietary tool FastVal to write validation documentation and execute Testing Protocols, which allows us to complete validation projects in 70% less time than traditional validation methods. We focus more of our time on testing your software and less time preparing documentation.

Ofni Systems will perform risk assessments to focus the validation effort on the most appropriate sections of your system.

Exceed your Standards and Expectations

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 software, databases, 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.

Industry Leading Validation Methodology

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:

Data to be entered into the system or database
Formulas or calculations used on each screen or form
Identifying who can enter the data into the system
Identify how the system meets applicable regulatory requirements, especially 21 CFR 11

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:

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 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.

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.

Additional Resources

Additional information is available on specific types of validation: