MASTERSHEETS

only spreadsheet designed for regulated industry

Reduce risk of non-compliance in GxP Calculations

Centralized Repository of all validated templates and digitally signed spreadsheets

Secure access to all spreadsheets using Granular Access Controls.

Track each change to the spreadsheet using signed and tamperproof Audit Trail.

Implement structured approvals using Configurable Workflow.

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LACK OF SECURITY CONTROLS & CENTRALIZED STORAGE

THE PROBLEM

Using spreadsheets like Excel™ to perform GxP calculations in a regulated environment is fraught with risks of non-compliance due to limited data protection, poor access control, and complexities in maintaining a single copy

THE SOLUTION

Mastersheets is a web-based spreadsheet application fully compliant with guidelines from major regulatory agencies like FDA, MHRA etc. It provides centralized storage with access control, robust audit trail and configurable approval workflow.

Fully Secured with 3 Levels of Access Control

Allow selected users to access the application using application-level access control (password controlled)

Define what each user can do with the spreadsheet using functionality level access control ( access based on roles and permissions)

Define which cells can be updated by user using Cell level access control

Centralized Repository

data integrity maintained

Maintain “Single Copy” of Validated Templates and all digitally signed Spreadsheets

only validated template

Ensure that each calculation is done only with validated template

easily searchable

Search spreadsheet by name, custom tags like batch number, product, location, type of test etc.

Configurable Workflow

Configure review and approval workflow, based on spreadsheet properties like process name, product, type of test, department etc.

Ensure that each template or spreadsheet is reviewed and approved by authorized people

Ensure that only approved templates are used for calculations

Robust Audit Trail

FDA COMPLIANT

DETAILED AUDIT TRAIL

ELECTRONICALLY SIGNED - All changes are electroncially signed.