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Data Integrity Categories
All 21 CFR Part 11 compliant |
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Excellence |
Advanced |
Standard |
| Audit Trail |
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Audit trail mode
Secure electronic records of system activities and actions (measurements, signing, exports, setting changes) with comment option. |
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| Electronic Signature |
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Electronic signature
Electronic verification of electronic data on different signing levels with comment option. |
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Enhanced electronic signature
Enhanced e-signature options for one-step/two-step signing (submission/approval only) and substitute signing. |
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| Data Security |
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Data printout
Fully traceable, GxP-compliant printout of data and instrument settings. |
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Protected data storage
"Ring-buffer" memory deactivation with stop of measurement operation prior to data removal. |
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Restricted time and date setting |
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Data backup
Data backup (measurements, checks, calibrations, settings, etc.), including instrument-specific disaster recovery. |
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Electronic data transfer
Data transfer using standard protocols (LAN, network share) or Anton Paar lab execution software, AP Connect Pharma. |
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| User Management |
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User management with fixed password rules
Creation and identification of users on three predefined levels (operator, manager, and administrator). |
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Individual user group management
Creation of user groups for individual user group management (e.g., start/stop, checks, change of settings, etc.). |
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Configurable password security
Enhanced security using complex passwords (upper/lower case, number, special character), and defined password expiration. |
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| Enhanced Compliance Features |
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Configurable visibility of measurement values
No real-time data on instrument display during measurement. Only final results are shown to avoid any user influence. |
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Raw data access and storage
Possibility to store, access, and review raw data after measurement. For some systems via dedicated software viewer. |
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Guided, selectable check limits & validity
Configurable limits to verify the validity of measurement data in regular (optional operationally mandatory) instrument checks. |
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Non-storage mode (with audit trail)
No data except for audit trail stored on the instrument. Immediate printout after each measurement necessary. |
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Non-deletable data mode
Function "archive" replaces function "delete" for secure data export and subsequent data removal. |
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External system control
Desktop software for system operation and control. For some instruments optional to embedded operation. |
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| Compatible Products |
Show all
Excellence instruments |
Show all
Advanced instruments |
Show all
Standard instruments |
