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Potentiometric Test Apparatus

Digital Automatic Potentiometric Titrator, Model: AUTO/POT–I (CF)

AUTO/POT–I (CF)

    Digital Automatic Potentiometric Titrator, Model: AUTO/POT–I (CF), is an advanced instrument designed to perform titrations with a focus on compliance with CFR 21 Part 11 regulations. This model encompasses a range of features and functionalities to ensure accurate and secure titration processes while adhering to stringent regulatory requirements.

    Key Features:

    • CFR 21 Part 11 Compliance: The instrument is specifically designed to comply with the requirements outlined in CFR 21 Part 11, ensuring data integrity and security in electronic records and signatures.

    • Multiple Titrant Methods: Supports two methods for Normality determination, including Standard Sample and Volumetric methods, providing flexibility in analytical procedures.

    • Multi-Peak Titrations: Capable of conducting single, double, and multi-peak titrations, accommodating various experimental scenarios.

    • User Levels and Access Control: Implements a three-tier user functionality system - Admin, Manager, and Operator, with role-based access control to ensure secure and controlled usage.

    • Secure Login: Utilizes a login screen to access the software, enhancing data protection and user accountability.

    • User Management Module: Incorporates a user management module for tasks such as account setup and editing, contributing to efficient user administration.

    • User Authentication: Ensures the uniqueness of user IDs and manages passwords in accordance with established guidelines.

    • Session Management: Implements system time-outs after periods of inactivity to safeguard against unauthorized access.

    • Audit Trail: Tracks and records the printing and reprinting of data, maintaining an audit trail with date and time stamps for thorough record-keeping and traceability.

    • Data Backup: Provides a back-up folder facility to secure data and prevent loss.

    • PC Interface: Supports PC connectivity through Ethernet, enabling data transfer and remote control.

    • Results Authentication: Requires operator authentication for results, with date and time stamps for added credibility.

    • Audit Trail for User Actions: Records all user actions in an audit trail, complete with date and time stamps, ensuring transparency and accountability.

    • Immutable Audit Trail: Prevents the editing of the audit trail, ensuring the integrity and reliability of recorded data.

    Additional Information:

    • The model AUTO/POT–I (CF) is an extension of the AUTO/POT-I model, enhanced with CFR 21 Part 11 compliance features.

    • The incorporation of CFR 21 Part 11 compliance ensures that the instrument meets the strict regulatory requirements for electronic records and signatures in pharmaceutical and other regulated industries.

    In summary, the Digital Automatic Potentiometric Titrator, Model: AUTO/POT–I (CF), offers advanced titration capabilities while upholding the highest standards of data integrity, security, and compliance. With its comprehensive features and user-friendly interface, it is well-suited for laboratories operating within regulated environments.








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