SOP for System and User Management for Chromatography Data Acquisition System [Chromeleon] –CDAS

1.0 OBJECTIVE:

To lay down the procedure to describes the system management process and responsibilities for the Chromatography Data Acquisition System [Chromeleon] - CDAS and the attached client systems. It covers the following aspects:

• Security and User Management
  • User Administration and User Access
  • Configuration Management
  • Access Security and Audit Trail
• Data Management
  • Data Backup and Recovery
  • Disaster Recovery
  • Definition of security measures preventing unauthorized user access

2.0 SCOPE:

The SOP is applicable at Quality Control department.

• IT related components of the CDAS, e.g. Chromeleon application (Administration Console), and User management.
• Analytical system related components to be covered by this system management SOP, e.g. Document management, Responsibilities, backup and recovery.

3.0 RESPONSIBILITIES:

3.1 Analyst

3.1.1 Requests for access to folders in the data structure according to his/her responsibilities from the Super User.

3.1.2 Informs the responsible Super user about incidents and problems observed during the work in the CDAS.

3.2 Executive /Super User

3.2.1 The Executive/ Super User is responsible for the qualified state of the local instrument (HPLC system).

3.2.2 Informs IT (Administrator) support for changes concerning access to the CDAS (e.g. User Creation, deregistration, change of role in the system).  

3.2.3 First line support for the users.

3.2.4 Advises / instructs the user in the use of the Chromeleon Software.

3.2.5 Adapts the folder structure and assigns Access groups & Roles according to the rules given in this SOP to Users.

3.2.6 Creates / modifies / maintains report templates & Instrument Method according to user requirement in line with Specifications & privileges.

3.2.7 Informs Department Head about all relevant incidents and problems observed during operation of the CDAS.

3.3 Reviewer

3.3.1 The Reviewer (QC/QA) is responsible for the Review of Chromatography data related to analysis & Audit Trail as per requirement & role.

3.4 Department Head (QC)

3.4.1 Approves Chromeleon access requests of the user (e.g. Analyst, Reviewer, Super Users, etc.).

3.4.2 Ensures that Support or the responsible Super User is informed about changes concerning a user (e.g. retirement) by means of Annexure-II.

3.5 IT (QA)/Administrator

3.5.1 Creating User Logins for Chromeleon Users (Administration console)

3.5.2 Execution Client locking and Unlocking

3.5.3 Execution of Backup Restore and Disaster recovery

4.0 PROCEDURE :

4.1 System Description

4.1.1 The software 'Chromeleon®' from Thermo Fisher Scientific is a chromatography data acquisition system (CDAS) with the following basic functionalities:

4.1.2 Control / monitoring of local chromatographic systems including an IPC running.

4.1.3 Chromeleon software and an instrument (e.g. HPLC).

4.1.4 Data acquisition and upload to the CDAS database and file repository.

4.1.5 Data evaluation.

4.1.6 Reporting of results.

4.2 Data management

1. The data managed in the CDAS data sources are the electronic raw data. It is essential that the data as well as the access to the data is well structured and that naming conventions for objects are defined.
2. Naming conventions for objects in Chromeleon

1. Processing methods and Instrument methods :-
   1. Processing Method and Instrument methods shall be created/given as per the SOP “Operation and Calibration of HPLC
2. Report definition files (.RDF files) (= report templates)

The naming of the report definition files is regulated as mentioned below:

1. For Area and Area % : XX_Area_Area%_XXX
2. For Area, Asymmetry and Theoretical plates: XXX_Area_AS_TH_XXX
3. For Area and Capacity factor: XXX_Area_K_XXX
4. For Area and Signal to noise: XXX_Area_SN_XXX
5. For Area and Resolution: XXX_Area_RES_XXX

• Note: - “XXX” will be the Scale of height for e.g if the scale is Autoscale it will be XXX_Area_Area%_Ascale, if the scale is -50 to 100 the naming will be XXX_Area_Area%_-50_100

1. Structures of data sources in CDAS

1. In CDAS data sources are configured as mentioned below:

* Access will be given to the user by Administrator during the required Year to save the data.

1. Description of the Data folders for User on Local PCs

1. Data Folder pattern for users in QC where local data will be saved and accessed.