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SOP for Operation of Chromeleon Software

Objective
This SOP's goal is to outline how to use Chromeleon software to operate in a network of Chromatographic equipment.

Scope
This SOP applies to Quality Control Department for User Account Management, Chromatographic System Access Control, and Data Management using Chromeleon software.

Procedure for Handling Chromeleon software

User Management System – Chromeleon software
Based on the database policies, users and groups are assigned. The regulations are:
  1. Administrator credentials and access groups - Administrators are members of all access groups.
  2. Client locking - Inactivity timeout any client device that has gone ten minutes without user input.
  3. Restrictions on passwords - A minimum password length of six characters must include an alphanumeric special character. Every three months, the login password will expire.
  4. User ID - defaults for the user ID For login purposes, the default user ID is Blank. The maximum number of attempted logins is 5, and if more attempts are made, the user account is locked.


Six types of privilege groups shall be identified:
  1. Administrator: For administrative purpose
  2. Reviewer: For monitoring of day to day activities
  3. Analyst: For analyst having limited privileges as required
  4. Service Engg: Only for maintenance and service purpose of instruments
  5. IT Personnel: Only for IT support
  6. QC Manager: Only for review


Data management system – Chromeleon software
A new data source shall be created every year with the Name “CMDATA_YYYY” and shall be mounted on each of the IPC at the start 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 the testing procedure

The sub folders shall be created in the above folders as follows:
  • AUDITS
  • Instrument ID
  • CALIBRATION
  • Instrument ID
  • 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 a 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 a 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 privileged group including the Reviewer and administrator privilege group shall have deletion rights.
Note 2: No abbreviated name is allowed, as there is a possibility that two analysts can have the same abbreviated name.


Creating and editing user – Chromeleon software
  • User accounts 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 a user ID, unlocking user ID or Updating the user privileges.

The user ID shall be created by IT personnel after approval from QC Head a
nd 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 login attempts is 5.
  • After reaching the 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 a change in a 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: The password of the user shall expire every after 3 months. In such cases, the user shall re-enter a new password and confirms the same.
  • To edit the user, click on “Edit user” and follow the above steps.
  • For the deactivation of the account of a user, tick mark on “Account locked” in logon failure.
  • To activate the account of the user (in case of the account is locked), remove the tickmark on “Account locked” in logon failure.

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

Policies on users – Chromeleon software
  • User accounts 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 an individual users 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 the following procedure:
  1. A query is created to move the locked sequence from the active data source to the archive data source, by this all locked sequences are moved automatically as per the schedule defined by the administrator.
  2. The reviewer shall lock the sequences after the review of data.
  3. The locked sequences shall always be unlocked as and when required by an administrator.
  4. 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 a backup job is scheduled to the Tape Drive.
Note: The backup is required to send the information for any incident that 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.
  • Change control shall be raised in the following cases.
  • Addition/deletion of IPC.
  • Any major modification in the server/network.
  • Any up-gradation of Chromeleon software.
  • Relocation of a 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

Customize 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

(Via Work list)

Create SEQ

 

X

X

X

Create SEQ Via Wizard

X

X

X

Create SEQ

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.

Abbraviations

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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