Ofni Systems incorporates the latest validation techniques from GAMP 5 to thoroughly and comprehensively validate your spreadsheets. Ofni Systems will:
- Identify key system requirements for your program, including identifying critical work-flows and security user groups. Each spreadsheet is analyzed and all VBA macros are evaluated.
- Evaluate the relative risk of each requirement and determine the proportionate quantity of testing.
- Develop requirement documents, including user specification requirements (URS), functional requirements specifications (FS or FRS) and software design specifications (DS or SDS) depending on your company requirements.
- Develop testing plans, installation qualifications (IQ), operational qualifications (OQ) and performance qualifications (PQ).
- Develop traceability matrix to ensure all requirements are tested.
- Execute testing protocols. Deviations, if they exist, will be reported and resolved
Are your spreadsheets compliant with 21 CFR Part 11?
ExcelSafe makes any Excel spreadsheet compliant. |
Compliance with 21 CFR 11
A key system requirement is compliance with 21 CFR Part 11. Ofni Systems will ensure your spreadsheet is compliant with 21 CFR Part 11, including:
- Audit Trails
- Electronic Signatures
- Limited System Access
- Password Controls
If your Excel spreadsheet does not already have the technological tools to be compliant with 21 CFR Part 11, we recommend ExcelSafe, which provides MS Excel with audit trails, limited system access, password controls and other technological tools.
How can Ofni Systems help you?
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Benefits of Spreadsheet Validation
Validation is required by the FDA to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. At Ofni Systems, we view validation as an opportunity to add value to their computer systems. Validating your spreadsheet allows you to:
- Submit data to regulatory organizations
- Use data to make quality and GxP decisions
- Control your data and who has access to the data
- Ensure your system performs to specifications
- Query your data to better understand your business process
- Have increased confidence in your system
Ofni Systems will quickly and efficiently assist you with all of your validation needs. Ofni Systems has
- Experience – Our validation professions have worked with large and small companies, in all aspects of FDA regulated fields from clinical trials to medical devices to biological products to generics
- Quality – At Ofni Systems, we pride ourselves on our ability to meet and exceed our most demanding customers’ needs
- Value – At Ofni Systems, we believe that validation should add value into the software development process. Our validations will review your software and document what works and what doesn't work
Let Ofni Systems' experience with validating MS Excel spreadsheets make validation simple for you.
View a sample Ofni System spreadsheet validation.
Key Benefits of Using Ofni Systems Validation
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