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During compliance audits, the FDA has recently focused more attention on the use of spreadsheets. Functional requirements describe what the spreadsheet must be able to do.(View sample warning letters relating to spreadsheets.) Ofni Systems, a leader in spreadsheet validation, can ensure that your spreadsheets are compliant with all regulatory requirements. This includes: Step 2: Document design requirements.When it comes to accuracy checks (as required in Annex 11 p 6), data integrity is an important issue.The Q&A document explains that both the files and the calculations should be secured in such a way that formulations are not accidentally overwritten.Accidental input of an inappropriate data type should be prevented or result in an error message.Example was designed to provide an example of validation documentation produced by Ofni Systems. The spreadsheet also calculates the volume squared and charts mass vs. A validation package will typically include additional documentation, including a validation plan, requirements traceability matrix, and validation summary report. Also in pharmaceutical companies, Excel Spreadsheets are used in different departments.
Ofni Systems uses proprietary tools to analyze spreadsheets to create comprehensive design specifications.
We use Excel Safe, which provides MS Excel with audit trails, limited system access, password controls, and other technological tools.
Ofni Systems will perform a free spreadsheet validation of one of your spreadsheets for qualified purchasers to demonstrate our validation method.
The first step of validating a spreadsheet or form is to outline the process requirements of the form or spreadsheet.
Key process requirements include: Rate each identified risk for its impact to both the overall company process operation and the validation project effort.
Risks should be identified, monitored and tasks assigned to allow responsibility, mitigation, closure and/or overall resolution.