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We would like to introduce you to iXLc which is a Spreadsheet Management Tool. Spreadsheets are used extensively by several departments of Life Sciences companies to perform or support GxP regulated activities. Some of the major concerns while using spreadsheets in such regulated environments are:• Enforcement of user access and availability of the latest version or specific templates of the spreadsheet.• Configuration of security within the template and spreadsheet to ensure that users cannot modify formulas, static text and specified cells within a spreadsheet.• Use of electronic signatures for reporting results and data. Authorised approvals in a paperless environment.• Audit trail of comments and review/approval cycle for spreadsheets.• Ensure that the printed copies of the spreadsheets contain the necessary information (Printer by User, Date/Time Stamp, and Current Status).• Compliance with USFDA -21 CFR Part 11and EU Annexure 11.• iXLc has been specifically designed and implemented to addresses all these concerns keeping in mind the requirements and regulations of the life sciences industry.
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Template ManagementAdministrators / Template Managers can customize existing spreadsheets using the templatemanagement tool. Using this tool, users with admin-istrator / template manager roles are ableto perform the following functions:Locking cells containing formulas, calculations and other static data to avoid manipulation by the end userMarking cells as optional or mandatory for user inputStoring customized templates in a central Storing customized templates in a central secure location
Spreadsheet ReviewThis application allows the user with reviewer access, to perform the following functions:Allowing the reviewer to overwrite cells marked as optional or mandatory (with an E-Sign impl-mented and details captured in the audit trail)E-Sign to complete the Review processSaving the file to a central secure locationSending an email notification to the user(s) / reviewer(s)
Spreadsheet ViewerThis application allows end users to view and print reviewed spreadsheets. While printing the following information is included in the printed copy to ensure compliance and control Printed Date/Time User Name User Name Status of Spreadsheet (Approved or Not ap proved) Spreadsheet Details (Project, File Name, etc.)
ivyworks
New SpreadsheetsThis application allows end users to generate new spreadsheets based on templates. This toolis deployed to the larger user base and will allow them to perform the following functions:
Edit only cells marked as optional or mandatory reviewer(s)Highlighting cells that are optional or mandatoryEnsuring that all mandatory cells have been completedSaving the file to a central secure location with Saving the file to a central secure location with a file name based on a pre-defined configurable naming conventionSending an email notification to the reviewer(s) for the review of the completed spreadsheet
Spreadsheets are completelylocked and stored in centralsecure locations
Spreadsheets cannot be accessed without the iXLcapplications
SpreadsheetsSpreadsheets cannot be stored locally
Implementation of E-Sign and Audit Trail
Inclusion of default information while printing (Date/ Time,User Name, Status, etc.)
ComplianceCompliance with 21 CFR Part 11 and EU Annexure 11
iXLcMicroso Excel Spreadshet Management Tool
# S-503, Manipal Centre, Dickenson Road, Bangalore - 560042, Karnataka, IndiaPhone: +91 80 41477219. Email: [email protected]
Microso
Excel
iXLc is a tool that is designed to efficiently manage Microsoft Excel spreadsheets. This tool allows organizations to control and centralize the management of spreadsheetsThe tool comprises of four applications built specifically to control the various aspects of spreadsheet management
Compliance – Incorporate regulatory and business requirements through templates
Minimize Risk - Prevent exposure through configuration of security
Secure - Limit modification rights to cells and spreadsheets through configuration
