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.
CIMCON's life cycle approach provides a full range of solutions to manage and control spreadsheets from discovery, risk assessment, and analysis; to monitoring, versioning, approvals and security.Discovery and Risk Assessment
Before you can really begin to effectively manage your spreadsheets, you need to know the extent to which they are in use in the organization by creating an inventory. Once you know how many spreadsheets exist, you then need to identify those that are critical.
EUC Insight Discovery is a server based application designed to scan your environment returning a multitude of detail on each spreadsheet as well as links and connectivity information associated with other databases. Knowing what spreadsheets are in existence, where they are and always being able to update your knowledge base is a huge value add and a key to true life cycle management of spreadsheets.Analysis and Validation
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 the Microsoft Excel application that helps you analyze your critical spreadsheets to identify and remove errors, and generate 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 outputPart 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.