“Audit Excel
” is a new “Additional Component” of Excel that governs a Preparation Models Process, Data Entry, Validation and Security Wizard of these data to Excel, recording, in parallel, an audit trail, in the form of unchangeable comments, and recording, on a dedicated DataBase to support, useful information for the management of access and Duties.
The definition of the logic of these Working Folders, is generally entrusted only to authorized users (ex. Heads of Service), even if the use of these logic should be allowed to a wider number of users (Lab Operators) sharing Folder in the network.
These considerations apply to any laboratory that uses MS / Excel for data management in support of activities of the Laboratory or Company that uses MS / Excel as part of a phase of the process relevant for the data management of a Product.
The Data Validation on MS / Excel requires a procedural approach and efficient software tools for the use of Sheets in accordance with current regulations :
(UNI EN ISO/IEC 17025, FDA CFR21 Part11, GMP EU Annex 11, GLP, GCP, ISO 13485).
The goal is to have sheets contained in a secure environment, using appropriate software supports.
These needs have long been highlighted and addressed mainly in the pharmaceutical sector, but also the ISO / IEC 17025 requires the clauses (4.3, 4.12, 5.4, 5.5) for the “data security” and their “protection”.
“Audit Excel” is a kind of “automaton” that guides the user in the management of prepared templates for supported input by automatic Audit Trail.
SUMMARY OF FEATURES:
- Automatic Audit Trail of Excel spreadsheet in “regulated” environments :
- UNI EN ISO/IEC 17025, GLP, GMP, GCP, ISO13485
- Software Providing Complete of “Validation kit” on the same SW
- No changes to the existing spreadsheet
- Guarantee of the correct application of procedures
- Simple procedure to activate and use
- Roles and tasks managed within a support DataBase