Spreadsheet Life Cycle Management
Excel spreadsheets are widely used throughout the life science industry whether it is in labs, manufacturing, research, or clinical settings. The reasons why Excel continues to be a solution of choice are well known: ease of use, familiarity with the application and ability to share data.
However, there are risks inherent in using spreadsheets including input and formula errors, lack of an audit trail, poor version and change control, and simply not knowing how many spreadsheets are in use and how they are linked.
Whether they are used for log or batch files, storing patient data, or calculations for lab notebooks, knowing, managing, and controlling spreadsheets is an important part of GxP, and ensuring they are validated to meet 21 CFR Part 11 compliance regulations is critical.
CIMINFO's life cycle approach provides a full range of solutions to manage and control spreadsheets from design, documentation, and testing validation, audit trails, security and electronic signatures.
Design, Documentation and Testing
XLValidator is a plug-in to Microsoft Excel that provides automated help in the design, documentationand testing of spreadsheets. During the design phase, it can help you understand the logic of your spreadsheet using tools such as Formula and Cell Analysis, Map Precedents and Dependents, and VBA/macro code analysis. It can automatically generate design documentation for the spreadsheet. The Heat Map detects errors and helps during testing in order to have an error-free spreadsheet.
Validation of a spreadsheet is a critical aspect to bringing the spreadsheet online and into a production, research or lab ready state. Spreadsheet validation is a time-consuming, error-fraught, intensive process.
XLValidator is a plug-in to Microsoft Excel that automatically generates validation documentation such as Design Specifications and Installation and Operational Qualification document templates that can then be modified to meet your company standards and procedures. By automating this process, XL Validator reduces time spent while increasing the accuracy of the output
Part 11 Compliance
If your spreadsheets are used in support of predicate rules, they must comply with 21 CFR Part 11 requirements for security, audit trail, and eSignatures.
eInfotree Excel Module is an easy-to-use, plug-in to Excel that allows for all of these controls to be added without modifying the user experience. Business continues without any adoption or training issues because the application in use hasn't changed. eInfotree Excel Module helps meet compliance regulations but also increases transparency in spreadsheet actions while ensuring no changes occur that can't be audited and reported on.