GMP Authorized User Roles and Permissions

User Roles and Permissions:

Role

Responsibilities

Permissions

Restricted Actions

Operator

Conducting AUC experiments in accordance with standard operating procedures (SOPs), and ensuring raw data is properly collected

Setting up and conducting experiments

Modifying data after submission and approving or rejecting experiments.

Reviewer

Reviews experiment results for scientific accuracy and SOP compliance

Access completed experiment data, and view audit trails.

Conducting experiments, modifying data, and approving or rejecting experiments.

Approver

Verifies that the experiment conducted is compliant with SOPs, and that other compliance documentation is in order.

Access completed experiment data, and view audit trails.

Conducting experiments, modifying data, and validating scientific accuracy of experiments.

Subject Matter Expert (SME)

Provides expertise on scientific accuracy and experiment validity.

Access completed experiment data.

Conducting experiments, and modifying data.

Role Assignment: Roles are assigned from the lab-specific UltraScan3 LIMS portal by a system administrator (Level 0 user), whose role is restricted to assigning user levels and roles. Each role is mutually exclusive to ensure a clear separation of responsibilities and maintain GMP compliance.

Note

The GMP module can be accessed using the drop-down ‘GMP’ menu located at the top of the UltraScan III module

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GMP Modules Access