ValProt is a Wizard-MS / Excel Add-in designed for the automation of processes of logical validation designed by the User on MS / Excel (R);
ValProt supports Validation, Documentation and Protection of the formulas made with MS / Excel.
(Dedicated Link www.Spreadsheetvalidation.it/en)
The Formulas Validation on MS / Excel requires a procedural approach and efficient software tools for the use of Spreadsheets in accordance with current regulations :
( UNI EN ISO/IEC 17025 + RT08 Accredia, GxP, FDA CFR21 Part11 ).
The goal is to have Spreadsheets validated and maintained in a safe environment, using appropriate software support for the automation of the process of validation, Documentation and Protection.
These needs have long been highlighted and addressed mainly in the pharmaceutical industry, but also the ISO / IEC 17025 requires the clauses (4.3, 4.12, 5.4, 5.5) for the “data security”, their “protection” and for the “Validation of logical calculation. ” In particular, paragraph 5.4.7 (Control Data) specifies that “… the software developed by the user must be documented in sufficient detail and suitably validated”. This requirement, according to the ACCREDIA interpretation, also applies to the development of Spreadsheet (ex. Formulas on MS / Excel or Visual Basic macros).
The System, through a support DataBase, guarantees the Access Control through permissions by-user, the Audit Trail of the Validate Folders, consultation of the state of validation and Log.
The Excel Folders validated through the use of “Valprot” can also be used by other compatible Spreadsheet (Opensource).