Many industries use Excel spreadsheets to handle regulated data and calculations on a daily basis (Batch release status, financial indicators, material weights, potency calculations, production data...).
The spreadsheets containing these highly critical data and calculations may require validation according to legal regulatory requirements (21 CFR Part 11, cGMP, BPx, Sarbanes Oxley, Directive 98/43/CE).
ADN's Solution
ADN offers a simple solution utilising the native functions of Excel and specially developed Visual BASIC macros. This approach has many technical advantages:
- Benefit from Windows session security (1 account, 1 password linked to Active Directory or not),
- Free of access security problems (external Audit trail and files),
- Benefits from the operating system session opening and file access.
- Audit Trail on all values and formulas incorporated into the Excel spreadsheet,
- To control the Excel functionalities (copy/paste, menus,...)
A Pre-validated solution
Our Pre-validation package will reduce the validation effort thanks to the following elements :
- Model specifications
- Risk Analysis
- Protocols
- Reports
A tested solution used by International Companies :
- Sanofi Pasteur,
- J&J Consumer,
- Roche,
- etc.
Example: Audit trail incorporated into the Excel sheet:
