Spreadsheet Validation Package
Your department manages a large collection of spreadsheets. You know the data needs to be collected in compliance with 21 CFR 11, but you’re just not sure where to begin. Ofni Systems can create a spreadsheet validation package to cover all of your department or company spreadsheets.
Ofni Systems will manage your entire spreadsheet validation project:
- Identify GxP Spreadsheets. Ofni validation professionals will perform a complete assessment of all of your spreadsheets, determine which spreadsheets require validation, and prioritize the validation efforts.
- Ensure Spreadsheet Compliance. A key validation requirement is compliance with 21 CFR Part 11. We use ExcelSafe, which provides MS Excel with audit trails, limited system access, password controls, and other technological tools.
- Validate Spreadsheets. Ofni Systems will document the functionality of each spreadsheet and verify that the spreadsheet works as expected. A typical spreadsheet validation includes a functional requirement specification, design specification, testing protocol, traceability matrix, and summary report.
Experts in Maximizing Validation Benefits
- Higher quality documentation produced efficiently and quickly. Ofni Systems uses FastVal to produce test plans and testing protocols designed to demonstrate that your system meets all of your business requirements and regulatory requirements outlined by 21 CFR Part 11. Using FastVal allows us to complete individual validation projects up to 70% faster than traditional validation methodology.
- Your documents, your standards. Our validation professionals use your existing documentation standards, producing validation documents identical to your existing validation documentation. Our validation professions can either follow your validation program or our own internal best practices.
- Industry leading experience. Ofni Systems is a leader in spreadsheet validation. Our experience can add value to your spreadsheet. We can suggest best practices for spreadsheet design and validation strategies.
- Validate the Excel spreadsheet file. Many Excel validations focus on just the paper output. Ofni Systems validates the electronic file, which allows the stored data to be used to make Quality and GxP decisions. It also allows users to query data and create excellent data tracking and trending tools.
Ofni Systems has experience working with all types of regulated industries, including pharmaceutical manufacturers, medical devices, CROs, and biologics. Large corporations trust Ofni Systems expertise to meet all of their validation standards and bring their spreadsheets into compliance quickly and efficiently. Small companies rely on Ofni Systems to meet their validation needs more conveniently and cost-effectively than hiring a validation staff, allowing them to focus on their core competencies.
Ofni Systems can validate your spreadsheets remotely or on-site. If you would prefer to have your own staff perform the validations, Ofni Systems can train your personnel to perform the validations.
Special Trial Validation Offer
Ofni Systems will perform a free spreadsheet validation of one of your spreadsheets for qualified purchasers to demonstrate our validation method.
Request a Quote or Free Spreadsheet validation