Chromeleon software – Operation & Privileges Policy

Standard Operating Procedure (SOP) for the working in network of Chromatographic system using Chromeleon software. Management of Chromatographic System Control and Privileges Policy in Chromeleon software.

Handling Procedure of Chromeleon Software

1.0   Objective :

  • The purpose of this SOP is to describe a procedure for the working in network of Chromatographic system using Chromeleon software.

2.0   Scope :

  • This SOP is applicable to Quality Control Department for Chromatographic System Access Control, User Account Management and Data Management through Chromeleon software.

3.0   Procedure for Handling of Chromeleon software:

    • User Management System – Chromeleon software :

    • The users and groups are designated based on the data base policies. The policies are :
    • Administrator access groups and privileges – Administrators belong to all access groups.
    • Client locking – Inactivity time out. Any client station without receiving user input for 10 minutes.
    • Password restrictions – Minimum password length shall be of 6 characters with alphanumeric special character. Logon password shall expire in every 3 months.
    • User ID defaults – Default user ID for logon shall be Blank. Allowed logon failure shall be 5 and exceeding 5 failure logon, shall lock the user account.
    • Six types of privilege groups shall be identified:
      • Administrator       : For administrative purpose
      • Reviewer             : For monitoring of day to day activities
      • Analyst                 : For analyst having limited privileges as required
      • Service Engg       : Only for maintenance and service purpose of instruments
      • IT Personnel        : Only for IT support
      • QC Manager       : Only for review
    • Data management system – Chromeleon software :

    • New data source shall be created every year with Name “CMDATA_YYYY” and shall be mounted on each of the IPC at the starting of the year.
    • CMDATA_YYYY
      • ALL PANELS: Panels for Control of Instruments
      • AUDITS: For storage of daily audit trails
      • CALIBRATION: For Calibration of Instruments
      • CALIBRATION TEMPLATES: For calibration sequence templates
      • CM_OQ: For Qualification of Chromeleon Software
      • METHOD: for Processing Method creation
      • PROGRAM: for Method creation
      • REPORTS: For Report Format Templates
      • SEQUENCES: For sequence creation as per testing procedure
    • The sub folders shall be created in the above folders as follows :

      • AUDITS
      • Instrument ID
      • CALIBRATION
      • Instrument IDChromeleon Software
      • CALIBRATION TEMPLATES
      • Instrument Model
      • CM_OQ
      • OQ
      • URS
      • REPORTS
      • Calibration
      • Routine
      • SEQUENCES
      • Instrument ID

Note: Additional directories / sub directories shall be created as and when required.

    • The naming of the sequence shall be as done as follows :
    • For e.g. PRODUCTNAME_DATE_VERSIONNO
    • DATE is the Date of Analysis
    • VERSION NO is the Number of Version of same date sequence
    • Access on data management – Chromeleon software :

    • Access to the above data management is controlled by user access groups in user management system.
    • The access groups are defined for each of the subdirectories made in HPLC DATA data source with the same name.
    • The users created under user management system are classified in these access groups.
    • For Example:
    • A user can access VALIDATION and PANELS by becoming member of QC_VALIDATION and ALL PANELS access group.
    • An analyst shall have only one username falling under single privilege/access groups.

Note 1: No privilege group including Reviewer and administrator privilege group shall have the deletion rights.

Note 2: No abbreviated name is allowed, as there is possibility that two analyst can have same abbreviated name.

    • Creating and editing user – Chromeleon software :

    • User account shall be created/ edited only by the IT Personnel after approval from QC Head and QA Head or respective designee.
    • The form shall be raised of “Chromeleon Software User ID Creation, Disable, Lock & Unlock user ID and Updation of User Privileges as per SOP.” by an initiator while creating, disable of an user ID, unlocking user ID or Updating the user privileges.
    • The user ID shall be created by IT personnel after approval from QC Head and QA Head or respective designee.

    • Double click on the “CmUser” icon on one of the client PC or Server.
    • Enter the user ID and password for login in “CmUser”.
    • After successful login “CmUser” screen shall be displayed.
    • Click on “New” icon, Click on “User data” and enter the User ID and User Name (to create a clone, select the user name from the drop down list).
    • Click on “Logon Password” then tick mark on “Logon Password expires” to 3 months.
    • Enter the default user then tick mark on “user and change logon password on next login”.
    • Click on “Logon failure” then tick mark on “Limit logon retries”.
    • The maximum number of allowed logon attempts are 5.

    • After reaching limit “Lock Account”.
    • Click on “OK”. The user shall be created. Check the privilege and access group of the user.
    • The new user shall open his / her account on any of the IPC by typing his / her user ID and the default password in the first entry, the window shall prompt for change in password where the user shall type his / her password.
    • The same needs to be confirmed by re-typing the password.
    • On completion this becomes his / her password on every login thereon.

Note: Password of the user shall expire every after 3 months. In such cases the user shall reenter a new password and confirm the same.

    • To edit the user, click on “Edit user” and follow the above steps.
    • For the deactivation of the account of user, tick mark on “Account locked” in logon failure.
    • To activate the account of user (in case of the account is locked), remove the tick mark on “Account locked” in logon failure.
  • Policies on administrator – Chromeleon software :

    • Administrator from QA shall be in operation.
    • In case the administrator changes, the following procedure shall be adopted:
    • The IT personnel shall create the new administrator (QA Head) in the presence of Quality head or prior approval from Quality Head.
    • The IT personnel shall deactivate the relieving administrator in the presence of QA head.
    • The only privilege that administrator does not have is deletion of data.
  • Policies on users – Chromeleon software

    • User account shall be created / edited only by the IT Personnel after approval from QC Head and QA Head or respective Designee.
    • Only qualified operators shall operate on the network.
    • The privilege of individual user can be changed as and when required by the IT Personnel after approval from QC Head and QA Head or respective Designee.
    • On periodic review, the inactive user shall be locked by the IT Personnel after approval from QC Head and QA Head or respective Designee.
  • Policies on data management – Chromeleon software :

    • Migration of data from the active data source (i.e., CMDATA_YEAR) to the archive data source (i.e. DATA-Backup) shall be done by following procedure:
    • A query is created to move the locked sequence from the active data source to the archive data source, by this all locked sequences moved automatically as per the schedule defined by the administrator.
    • The reviewer shall lock the sequences after the review of data.
    • The locked sequences shall always be unlocked as and when required by an administrator.
    • Audit trail from the local IPC to the server (i.e. AUDIT folder on the CM data source) shall be done frequently by the authorized IT personnel.
  • General policies – Chromeleon software :

    • The server shall be rebooted as and when required by the authorized IT personnel to ensure optimal performance of the server.
    • Any maintenance carried out shall be done with prior intimation to administrator and risk involved shall be evaluated.
    • Backup of the data from the network shall be done as per our SOP Procedure for Archiving, Storage and retrieval of electronically generated and Processed Data.
    • For this, Symantec Backup Agent is used where backup job is scheduled to the Tape Drive.

Note: The backup is required to send the information for any incident takes place in the network to the manufacturer.

    • All incidents pertaining to network / server shall be documented.
    • Appropriate action for the incidents, if required, shall be taken in consultation with IT / QA.
      • Addition / deletion of IPC.
      • Any major modification in the server / network.
      • Any up-gradation of Chromeleon software.
      • Relocation of server.
      • Relocation of IPCs.
    • Privilege Group
    • Privileges shall be assigned to each user group as follows:
  • Privileges of CM-SERVER CONTROL – Chromeleon software :

Privilege Categories Privileges Privilege Groups
Analyst Reviewer IT Personnel Service Engg Administrator QC

Manager

CM-Server Installation
 

 

Modify Configuration X X
Control Panels
Create PAN X X X         X
Delete PAN X X X X X         X
Modify PAN X X X         X
Copy PAN X X X         X
Move PAN X X X         X
Edit Script Button X X X         X
Program Files
Create PGM X X        X
Delete PGM X X X X X        X
Modify PGM X X        X
Copy PGM X        X
Move PGM X X        X
Audit Trails
Copy Audit Trail X X X        X
Move Audit Trail X X X        X
Delete Audit Trail X X X X X        X
Rename Audit Trail X X X X        X
Online Control
Monitor Time Base X      X
Control Time Base X      X
Take Over Control X      X
Run Batch X      X
Acquire Data X      X
Control Foreign Batch X      X
Predictive Performance
Change performance limit X X X X      X
Change Qualification interval X X X X      X
Override Qualification X X X X X      X
Approve Qualification X X X X X      X
  • Privileges of DATA SOURCE – Chromeleon software :

Privilege Categories Privileges Privilege Groups
Analyst Reviewer IT Personnel Service Engg Administrator QC

Manager

Basics
Create DS X X X
Mount Dismount DS X X X
Rename DS X X X X
Customise DS X X
Modify History Mode X X X X
Modify History Comment X X X X
Modify Protection Mode X X X X
Modify DSA vailability X X X X X
Directories
Create DIR X X
Delete DIR X X X X X X
Rename DIR X X
Copy DIR X X
Move DIR X X
Lock DIR X X
Unlock DIR X X X
Modify Access Group DIR X X X
Queries
Create QRY X
Delete QRY X X X X X X
Modify QRY X
Copy QRY X
Move QRY X X
Execute QRY X
  • Privileges of SEQUENCE – Chromeleon software :

Privilege Categories Privileges Privilege Groups
Analyst Reviewer IT

Personnel

Service

 Engg

Administrator QC

Manager

Sequences
Create SEQ X X X
Create SEQ Via Wizard X X X
Create SEQ Via Work list X X X X X
Modify SEQ X X       X
Rename SEQ X X X
Rename SEQ with Raw Data X X X X X
Copy SEQ X X X X
Move SEQ X X X X X
Delete SEQ X X X X X X
Delete Signed SEQ X X X X X X
Delete Locked SEQ X X X X X X
Lock SEQ X X X X X
Unlock SEQ X X X X X
Customize Col Layout SEQ  

X

X X
Samples
Copy Samples X X X X X
Insert New Samples X X X
Append New Samples X X X
Modify Finished Sample X X X X
Modify Finished Status X X X X X X
Delete Finished Sample X X X X X X
Delete Raw Data X X X X X X
Signature
Submit result X X X X X
Review Result X X X X X X
Approve Result X X X X X
Undo submit result X X X X X X
Undo Review result X X X X X
Undo Approve Requirement X X X X X
Modify Sign Requirement X X X X X
Sign result X X X X X X
Undo Sign Result X X X X X X
  • Privileges of DATA REDUCTION – Chromeleon software :

Privilege Categories Privileges Privilege Groups
Analyst Reviewer IT

Personnel

Service

Engg

Administrator QC

Manager

QNT Methods
Create QNT X X X
Delete QNT X X X X X X
Modify QNT X X X
Copy QNT X X X
Move QNT X X X X
Manipulate Peaks X X X X X
Delete Peak Manipulations X X X X X
Customize Col Layout

QNT Delete Pea

X X X
Spectra Libraries
Create LIB X X X
Delete LIB X X X X X X
Modify LIB X X X
Copy LIB X X X
Move LIB X X X X X
Add Lib Spectra X X X
Delete Lib Spectra X X X X X X
  • Privileges of REPORTING – Chromeleon software :

Privilege Categories Privileges Privilege Groups
Analyst Reviewer IT Personnel Service Engg Administrator QC Manager
Report Definition Files
Create RDF X X X
Delete RDF X X X X X X
Modify RDF X X X
Copy RDF X X
Move RDF X X X
Allow Plot Property Changes X X
Print Export Unsaved Data X X X X X
Batch
Run Print Batch X X
Run Export Batch X X
  • Privileges of MISCELLANEOUS – Chromeleon software :

Privilege Categories Privileges Privilege Groups
Analyst Reviewer IT Personnel Service Engg Administrator QC Manager
Workspaces
Create WSP X X X X
Delete WSP X X X X X X
Modify WSP X X X X
Copy WSP X X X X
Move WSP X X X X
Archive
Restore X X
Backup X X X
Import Peak Net Data X X X X
Import AIA X X X X
Import Chem. Station Data X X X X

√ = Privilege given     X = Privilege not given

Note : cmadmin is the member of Standard Privilege Group which is a default Privilege Group created at the time of installation of Chromeleon software and is not in use.

4.0   Glossary – Chromeleon software :

CC : Change control Number ID : Identification
HPLC : High performance liquid chromatography CM : Chromatography management system
IT : Information Technology FP : Finished Product
STAB : Stability RM : Raw Material
i.e. : That is PC : Personal Computer
IPC : Instrument PC CD : Compact Disk
WS : Working Standard USB : Universal Serial Bus
DS : Data source DIR : Directories
QRY : Queries SEQ : Sequence
QNT : Quantification LIB : Library
RDF : Report definition file AIA : Analytical instrument association

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Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

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