QCSheet

QCSheet is a web-based application developed by Webosphere for automating routine calculation sheets in quality control environments within the life sciences industry. It is designed to operate in a compliance-ready and secure environment, supporting online calculation and review of electronic sheets with minimal or no manual data transcription.

The system captures result values directly from instruments, populates other values based on product or fixed value selections, and auto-executes rules and formulas to derive final results. Draft templates, sheets, and STP entry forms can be designed dynamically, with version control and audit trails maintained for all changes made to forms, sheets, or templates.

Core Capabilities

• Direct capture of result values from instruments, reducing manual transcription
• Auto-execution of rules and formulas to derive final results
• Dynamic design of draft templates, calculation sheets, and STP entry forms
• Version control for all templates and sheets
• Audit trails for every action performed by users, including changes to forms and templates
• Role-based and location-based user access permissions
• Print control with the ability to capture and audit sheet print details
• Centralized, web-based access from any location

Key Differences Compared to Excel-Based Workflows

• Centralized template repository management, reducing IT team effort and enabling access from any location, compared to the difficulty of managing distributed Excel template files
• Validation is performed once at system installation and then only for individual formulas or rules, rather than requiring cell-by-cell validation of every Excel template sheet
• User access permissions are managed role-wise and location-wise with audit trails, rather than being assigned individually to each Excel file
• Full audit trails are maintained for all user actions, whereas Excel does not provide audit trails for template interactions
• Template versioning and discarding procedures are managed with accompanying audit trails, which are not available in Excel
• Print records are captured and audited, a capability not present in Excel
• The system has undergone a USFDA audit and received approval at a client site

QCSheet is delivered as a centralized web application, making it accessible from multiple locations without the constraints of a desktop-based tool. It is positioned for life sciences organizations seeking digital transformation and automation of quality control documentation processes, with a focus on compliance requirements including audit trail integrity and validation efficiency.