MS Excel has a wide range of applications in various industries due to its ease of use and flexibility. In the GxP environment, a systematic approach is needed to develop and validate Excel to ensure data compliance. In addition to validation and qualification, records generated through Excel templates and calculations are considered electronic records which should comply to relevant regulations such as 21 CFR Part 11, for ER/ES (Electronic Records/Electronic Signature). As Excel is not specifically designed for compliance environments, MS Excel lacks audit trail and electronic signatures feature, both of which are essential for regulation.

WindSheet compliant electronic record and automatic calculation system is the world's first Brower-Server architecture system that integrates online spreadsheets, databases, and file management. It not only inherits the flexible and easy-to-use characteristics of Excel spreadsheets, but also meets the compliance requirements of the pharmaceutical industry. The system adopts secure online spreadsheet technology to centrally control all template files and SpreadSheet files, which not only perfectly solves the problem of compliant use of spreadsheets, but also further expands the scope of use of spreadsheets in the GxP field. The system can import existing Excel spreadsheet files with one click, or design or edit spreadsheet templates online in the browser, without relying on local MS Excel to run. It also adds various functional controls such as barcode generation, date and time selectors, multi-level cell menus, etc.

Features;

ü  Web-Based standalone system without depending on local MS Office while compatible with any MS Excel files.

ü  Audit trail on Spreadsheet cell changes and electronic signature can meet 21CFR Part 11 requirements.

ü  No installation needed on the client side.

ü  Pure Online Spreadsheets centralized stored in Database without any trace on local disks.

ü  Similar user experience and interface to the MS Excel.

ü  Template publish enable strict control for usage.

ü  Active Domain or built-in user authentication

ü  Group management and role-based privilege assignment.

ü  Workflow design adapting to any business scenarios

ü  Enforces password security policy,including account lockouts after a configurable number of retries and automatic Session Timeouts.

Benefits

1.  Simple and effective replacement of Excel Spreadsheets for 21 CFR Part 11 compliance.

2.  Easy to use by Web access on Windows, Android and Mac.

3.  Quick deployment by importing existed Excel templates without any extra modifications.

4.  Easy to configure, use and maintain.

5.  Files stored in database and can be exported as Excel files of PDF files.

6.  Reduced validation effort using available validation package.