Chrompass: Tools for regulatory compliance
Chrompass: Tools for regulatory compliance
- Chrompass: Chromatography Data System
- Chrompass: Tools for regulatory compliance
- Chrompass: System control & data Acquisiton
- Chrompass: Data processing & integration
Meeting the stringent requirements of 21 CFR Part 11
- Access rights control for secure systems
- Audit trail function for tracking records
- Electronic signature for record integrity
- Electronic records in PDF format
Access rights control for secure systems
The ChromPass Configuration Manager provides the means to create, configure and maintain detailed information regarding system security, user management, data path, instrument control, etc. User profiles defined in the Configuration Manager control the users access to methods, data, and reports. Security is managed through user ID and password checks.
Audit trail function for tracking records
A rigorous Audit Trail tool records and archives all operations and file modifications with an automatically incremented version number. Details of various file versions, e.g., chromatograms, methods, sequences, and calibration curves, are viewed on-screen.
Electronic signature for record integrity
Processd chromatograms and corresponding records can be locked when electronically signed by authorized users. Only the same authorized users can unlock these files.
Electronic records in PDF format
When final reports are issued, approved, and electronically signed, a PDF file is automatically generated. All signature/locking operations are tracked in the audit trail.
The user base to be defined by the ChromPass Configuration Manager
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Company |
This is the name of the company where the JASCO ChromPass Chromatography Data System is installed. |
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Group |
A group is a logical entity, which is a part of the company, for example you can have QC group, research group, etc. |
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Profile |
A profile is the set of rights assigned to a user. User access to software features may be allowed or denied according to their profile. |
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Project |
A project is a logical entity which is a part of a group, for example, inside the QC group, different projects such as molecular analysis or techniques can exist. Each project can have its own shared data such as method or report style. |
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User |
A user is a physical entity, and must be associated to a project inside a group / company. Users will have certain specific rights. |
Access control through user profiles
The Create/Edit Profile wizard defines privileges of users to access the functions listed. Check the box in front of the function to allow it, or uncheck to deny it. If you uncheck a function, it will not be accessible for the corresponding users in this profile.
