- The spreadsheet can be used to record and manipulate (Change, Delete, add) GxP data and as such need to be managed to ensure the continued integrity and security of the data.
- We develop spreadsheets that comply with different regulatory requirements.
Spreadsheet Development
- Input and output areas are separated;
- Calculations, constants and parameters cannot be changed by the user (locked cells);
- A blank template is used – the use of “master copies” with typical data should be avoided; and
- Password-protected template (at sheet and workbook).
- Password Policy unique user login, lock and unlock user, maximum user login failed attempt
- Fulfills 21 CFR Requirement like Audit Trail, Log File and User login activity.
- Configure access rights to the different user levels.
- Apply the principles of change control when spreadsheets are updated (multi-user applications and single-user template)
- General requirements for records
- Fully document the above process using a comprehensive validation approach
Spreadsheet Validation
When the spreadsheet has been developed the file should be transferred to the Validation team and will prepare a suitable test protocol using the appropriate template.
- User Requirement Specification
- Functional Requirement Specification
- Installation and Security
- Operation and Performance Qualification Protocol
- Evaluation Requirements
- Tractability Matrix
- Final Reports
- Addition to Computer Inventory