Spreadsheet Development & Validation
Spreadsheets are widely used in regulated industries to perform GMP-related calculations, trend analysis, calibration and qualification planning, and laboratory asset management. When developed and validated as per regulatory compliance, spreadsheets can significantly reduce risks in performing GxP work, enhance efficiency, and lower regulatory exposure.
However, unvalidated spreadsheets often pose compliance risks. Regulatory audits frequently highlight nonconformities such as inadequate controls, lack of documentation, or security gaps. These risks can compromise data integrity and create unnecessary compliance issues.
Regulatory References for Spreadsheets
- 21 CFR Part 11.10(e): Spreadsheet applications must be protected with documentation and security measures.
- ISO 13485; Clause 7.5.2.1: Validation of software applications used for service provision must meet defined requirements.
- FDA Laboratory Manual of Quality Procedures (Volume III 4.5): Development and validation of spreadsheets for data collection.
- OECD No. 17; Section 1.7: For non-complex applications (e.g., spreadsheets), verification against user requirement specifications may be sufficient.
Functionalities We Develop in Spreadsheets
- User Management Facility integrated within spreadsheets.
- Comprehensive Audit Trail with date and time stamps.
- Hide/Unhide row and column functionality.
- Configurable decimal settings with increase/decrease options.
- Hide/Unhide entire tables for controlled visibility.
- Automatic display of file path and username during printing.
- Password protection for enhanced security.
- Dropdown-based unit conversion with automated calculations.
- Data linking between multiple sheets within a workbook.
- Additional customized functionalities tailored to client requirements.
