STANDARD OPERATING PROCEDURE

Title: OPERATING SYSTEM AND SECURITY POLICIES

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1.0 OBJECTIVE:
1.1 To lay down the procedure to configure the basic policies for user accounts, general security for
data and maintenance for desktops.
2.0 SCOPE:
2.1 This procedure is applicable to all the computers in CRONUS PHARMA SPECIALITES INDIA
PVT LTD, Hyderabad.
3.0 RESPONSIBILITY:
3.1 IT is responsible for the configuration of such policies.
3.2 All the users in the Cronus Pharma have to follow this procedure.
3.3 IT & team are responsible to supervise and comply with this procedure.
3.4 Head QA/Designee is responsible for compliance of this procedure.
4.0 PROCEDURE:
4.1 Basic security and group policies.
1.1.1. User login account policies for the operating system.
1.1.2. User name and password combination is unique for that particular user and it is the electronic
identification of that user.
1.1.3. Creation and deletion of user account is under the responsibility of IT.
1.1.4. Maintenance of user password is under responsibility of respective user with the help of IT.
1.1.5. For reactivation and missing password users have to consult IT.

Details Prepared by Reviewed by Approved by

Sign & Date
Name Krishnamurthy M K Veerendar Ch. Ramachandra Rao B. Suman Rao

Designation Manager Manager Senior Manager GM

Department IT IT Quality Assurance Quality Assurance
Annexure No.: CPL/QA/001/A01-00
 STANDARD OPERATING PROCEDURE
Title: OPERATING SYSTEM AND SECURITY POLICIES
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1.1.6. IT is responsible for deactivate\disable the User account on his\her last working day.
1.1.7. Previous login user name shall not be visible at new login.
1.2. User privilege for operating system of computers
1.2.1. Each user shall have a unique combination of user identification and password.
1.2.2. The password shall be confidential.
1.2.3. There are two types of common user groups
a. Administrator level
b. User level
1.3. General policies and privileges for the Administrator level users
1.3.1. The administrator level users shall have rights to access / modify / control all features of the
computer system.
1.3.2. IT personnel will have the rights to access administrator level.
1.4. General policies and privileges for the user level users
1.4.1. All the computer users of Cronus Pharma come under user level.
1.4.2. Users are restricted to Copy, Paste, Delete any kind of electronic raw data files from raw data
storage folder of the application software generated by systems.
1.4.3. Computer lockout mechanism shall be configured to prevent unauthorized access to operating
system when system is ideal.
1.4.4. They cannot use CD writer / Floppy drive/ USB flash drives.
1.4.5. All the users by default will be the members of restricted users group.
Details Prepared by Reviewed by Approved by
Sign & Date
Name Krishnamurthy M K Veerendar Ch. Ramachandra Rao B. Suman Rao

Designation Manager Manager Senior Manager GM

Department IT IT Quality Assurance Quality Assurance
Annexure No.: CPL/QA/001/A01-00
 STANDARD OPERATING PROCEDURE
Title: OPERATING SYSTEM AND SECURITY POLICIES
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1.4.6. They cannot change Date, Time and Time zone of the system.
1.5. Security policies
1.5.1. Password Policy
1.5.2. All passwords shall have a minimum number of six characters. Passwords must be complexity
(combination of alphabets and numbers).
1.5.3. Password shall not be copied by anyway.
1.5.4. Password will expire in 90 days.
1.5.5. Passwords shall not be repeated for at least 3 changes.
1.5.6. During first login, system will ask to change the password given by the IT personnel.
1.5.7. Folder level security policy
 Each user will have network drive to store their data, which is not accessible by other users.
Network Drives will back up into Magnetic tapes.
 Data exported by the software (Empower, Lab X, etc.) will be stored in the network drive and
available to only respective users.
 The folders, which are used by multi user, shall have access by network drive and configuration
to the respective user in a predefined manner approved by head of the department.
1.6. Network connections settings
1.6.1. Network settings are configured for Network Connections for Security Purpose.
1.6.2. Disabled to rename LAN connections or remote access connections available to all users.

Details Prepared by Reviewed by Approved by

Sign & Date
Name Krishnamurthy M K Veerendar Ch. Ramachandra Rao B. Suman Rao

Designation Manager Manager Senior Manager GM

Department IT IT Quality Assurance Quality Assurance
Annexure No.: CPL/QA/001/A01-00
 STANDARD OPERATING PROCEDURE
Title: OPERATING SYSTEM AND SECURITY POLICIES
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1.6.3. Prohibited access to properties of components of LAN connections.

1.6.4. Prohibited the TCP/IP advanced configurations.
1.6.5. Prohibited the enabling/disabling components of LAN connection.
1.7. Antivirus policy
1.7.1. For security of the data from the various viruses, ISD installed Antivirus software on Server and
all its client computers in entire network.
1.7.2. The definition of the antivirus shall be updated automatically by using the Antivirus server on
regular basis
Basic security and group policies.
1.8. User login account policies for the operating system.
1.9. User name and password combination is unique for that particular user and it is the electronic
identification of that user.
1.10. Creation and deletion of user account is under the responsibility of IT.
1.11. Maintenance of user password is under responsibility of respective user with the help of IT.
1.12. For reactivation and missing password users have to consult IT.
1.13. IT is responsible for deactivate\disable the User account on his\her last working day.
1.14. Previous login user name shall not be visible at new login.
1.15. User privilege for operating system of computers
1.16. Each user shall have a unique combination of user identification and password.

Details Prepared by Reviewed by Approved by

Sign & Date
Name Krishnamurthy M K Veerendar Ch. Ramachandra Rao B. Suman Rao

Designation Manager Manager Senior Manager GM

Department IT IT Quality Assurance Quality Assurance
Annexure No.: CPL/QA/001/A01-00
 STANDARD OPERATING PROCEDURE
Title: OPERATING SYSTEM AND SECURITY POLICIES
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1.17. The password shall be confidential.

1.18. There are two types of common user groups
1.19. Administrator level
1.20. User level
1.21. General policies and privileges for the Administrator level users
1.22. The administrator level users shall have rights to access / modify / control all features of the
computer system.
1.23. IT personnel will have the rights to access administrator level.
1.24. General policies and privileges for the user level users
1.25. All the computer users of Cronus Pharma come under user level.
1.26. Users are restricted to Copy, Paste, Delete any kind of electronic raw data files from raw data
storage folder of the application software generated by systems.
1.27. Computer lockout mechanism shall be configured to prevent unauthorized access to operating
system when system is ideal.
1.28. They cannot use CD writer / Floppy drive/ USB flash drives.
1.29. All the users by default will be the members of restricted users group.
1.30. They cannot change Date, Time and Time zone of the system.
1.31. Security policies
1.32. Password Policy

Details Prepared by Reviewed by Approved by

Sign & Date
Name Krishnamurthy M K Veerendar Ch. Ramachandra Rao B. Suman Rao

Designation Manager Manager Senior Manager GM

Department IT IT Quality Assurance Quality Assurance
Annexure No.: CPL/QA/001/A01-00
 STANDARD OPERATING PROCEDURE
Title: OPERATING SYSTEM AND SECURITY POLICIES
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1.33. All passwords shall have a minimum number of six characters. Passwords must be complexity
(combination of alphabets and numbers).
1.34. Password shall not be copied by anyway.
1.35. Password will expire in 90 days.
1.36. Passwords shall not be repeated for at least 3 changes.
1.37. During first login, system will ask to change the password given by the IT personnel.
1.38. Folder level security policy
1.39. Each user will have network drive to store their data, which is not accessible by other users.
Network Drives will back up into Magnetic tapes.
1.40. Data exported by the software (Empower, Lab X, etc.) will be stored in the network drive and
available to only respective users.
1.41. The folders, which are used by multi user, shall have access by network drive and configuration
to the respective user in a predefined manner approved by head of the department.
1.42. Network connections settings
1.43. Network settings are configured for Network Connections for Security Purpose.
1.44. Disabled to rename LAN connections or remote access connections available to all users.
1.45. Prohibited access to properties of components of LAN connections.
1.46. Prohibited the TCP/IP advanced configurations.
1.47. Prohibited the enabling/disabling components of LAN connection.

Details Prepared by Reviewed by Approved by

Sign & Date
Name Krishnamurthy M K Veerendar Ch. Ramachandra Rao B. Suman Rao

Designation Manager Manager Senior Manager GM

Department IT IT Quality Assurance Quality Assurance
Annexure No.: CPL/QA/001/A01-00
 STANDARD OPERATING PROCEDURE
Title: OPERATING SYSTEM AND SECURITY POLICIES
SOP No.: CPL/IT/004 Page No.: 7 of 17
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1.48. Antivirus policy

1.49. For security of the data from the various viruses, ISD installed Antivirus software on Server
and all its client computers in entire network.
1.50. The definition of the antivirus shall be updated automatically by using the Antivirus server on
regular basis
1.51. Basic security and group policies.
1.52. User login account policies for the operating system.
1.53. User name and password combination is unique for that particular user and it is the electronic
identification of that user.
1.54. Creation and deletion of user account is under the responsibility of IT.
1.55. Maintenance of user password is under responsibility of respective user with the help of IT.
1.56. For reactivation and missing password users have to consult IT.
1.57. IT is responsible for deactivate\disable the User account on his\her last working day.
1.58. Previous login user name shall not be visible at new login.
1.59. User privilege for operating system of computers
1.60. Each user shall have a unique combination of user identification and password.
1.61. The password shall be confidential.
1.62. There are two types of common user groups
1.63. Administrator level

Details Prepared by Reviewed by Approved by

Sign & Date
Name Krishnamurthy M K Veerendar Ch. Ramachandra Rao B. Suman Rao

Designation Manager Manager Senior Manager GM

Department IT IT Quality Assurance Quality Assurance
Annexure No.: CPL/QA/001/A01-00
 STANDARD OPERATING PROCEDURE
Title: OPERATING SYSTEM AND SECURITY POLICIES
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1.64. User level

1.65. General policies and privileges for the Administrator level users
1.66. The administrator level users shall have rights to access / modify / control all features of the
computer system.
1.67. IT personnel will have the rights to access administrator level.
1.68. General policies and privileges for the user level users
1.69. All the computer users of Cronus Pharma come under user level.
1.70. Users are restricted to Copy, Paste, Delete any kind of electronic raw data files from raw data
storage folder of the application software generated by systems.
1.71. Computer lockout mechanism shall be configured to prevent unauthorized access to operating
system when system is ideal.
1.72. They cannot use CD writer / Floppy drive/ USB flash drives.
1.73. All the users by default will be the members of restricted users group.
1.74. They cannot change Date, Time and Time zone of the system.
1.75. Security policies
1.76. Password Policy
1.77. All passwords shall have a minimum number of six characters. Passwords must be complexity
(combination of alphabets and numbers).
1.78. Password shall not be copied by anyway.

Details Prepared by Reviewed by Approved by

Sign & Date
Name Krishnamurthy M K Veerendar Ch. Ramachandra Rao B. Suman Rao

Designation Manager Manager Senior Manager GM

Department IT IT Quality Assurance Quality Assurance
Annexure No.: CPL/QA/001/A01-00
 STANDARD OPERATING PROCEDURE
Title: OPERATING SYSTEM AND SECURITY POLICIES
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1.79. Password will expire in 90 days.

1.80. Passwords shall not be repeated for at least 3 changes.
1.81. During first login, system will ask to change the password given by the IT personnel.
1.82. Folder level security policy
1.83. Each user will have network drive to store their data, which is not accessible by other users.
Network Drives will back up into Magnetic tapes.
1.84. Data exported by the software (Empower, Lab X, etc.) will be stored in the network drive and
available to only respective users.
1.85. The folders, which are used by multi user, shall have access by network drive and configuration
to the respective user in a predefined manner approved by head of the department.
1.86. Network connections settings
1.87. Network settings are configured for Network Connections for Security Purpose.
1.88. Disabled to rename LAN connections or remote access connections available to all users.
1.89. Prohibited access to properties of components of LAN connections.
1.90. Prohibited the TCP/IP advanced configurations.
1.91. Prohibited the enabling/disabling components of LAN connection.
1.92. Antivirus policy
1.93. For security of the data from the various viruses, ISD installed Antivirus software on Server
and all its client computers in entire network.

Details Prepared by Reviewed by Approved by

Sign & Date
Name Krishnamurthy M K Veerendar Ch. Ramachandra Rao B. Suman Rao

Designation Manager Manager Senior Manager GM

Department IT IT Quality Assurance Quality Assurance
Annexure No.: CPL/QA/001/A01-00
 STANDARD OPERATING PROCEDURE
Title: OPERATING SYSTEM AND SECURITY POLICIES
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1.94. The definition of the antivirus shall be updated automatically by using the Antivirus server on
regular basis
1.95. Basic security and group policies.
1.95.1. User login account policies for the operating system.
1.95.2. User name and password combination is unique for that particular user and it is the electronic
identification of that user.
1.95.3. Creation and deletion of user account is under the responsibility of IT.
1.95.4. Maintenance of user password is under responsibility of respective user with the help of IT.
1.95.5. For reactivation and missing password users have to consult IT.
1.95.6. IT is responsible for deactivate\disable the User account on his\her last working day.
1.95.7. Previous login user name shall not be visible at new login.
1.96. User privilege for operating system of computers
1.96.1. Each user shall have a unique combination of user identification and password.
1.96.2. The password shall be confidential.
1.96.3. There are two types of common user groups
c. Administrator level
d. User level
1.97. General policies and privileges for the Administrator level users
1.97.1. The administrator level users shall have rights to access / modify / control all features of the
computer system.
Details Prepared by Reviewed by Approved by
Sign & Date
Name Krishnamurthy M K Veerendar Ch. Ramachandra Rao B. Suman Rao

Designation Manager Manager Senior Manager GM

Department IT IT Quality Assurance Quality Assurance
Annexure No.: CPL/QA/001/A01-00
 STANDARD OPERATING PROCEDURE
Title: OPERATING SYSTEM AND SECURITY POLICIES
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1.97.2. IT personnel will have the rights to access administrator level.

1.98. General policies and privileges for the user level users
1.98.1. All the computer users of Cronus Pharma come under user level.
1.98.2. Users are restricted to Copy, Paste, Delete any kind of electronic raw data files from raw data
storage folder of the application software generated by systems.
1.98.3. Computer lockout mechanism shall be configured to prevent unauthorized access to operating
system when system is ideal.
1.98.4. They cannot use CD writer / Floppy drive/ USB flash drives.
1.98.5. All the users by default will be the members of restricted users group.
1.98.6. They cannot change Date, Time and Time zone of the system.
1.99. Security policies
1.99.1. Password Policy
1.99.2. All passwords shall have a minimum number of six characters. Passwords must be complexity
(combination of alphabets and numbers).
1.99.3. Password shall not be copied by anyway.
1.99.4. Password will expire in 90 days.
1.99.5. Passwords shall not be repeated for at least 3 changes.
1.99.6. During first login, system will ask to change the password given by the IT personnel.
1.99.7. Folder level security policy

Details Prepared by Reviewed by Approved by

Sign & Date
Name Krishnamurthy M K Veerendar Ch. Ramachandra Rao B. Suman Rao

Designation Manager Manager Senior Manager GM

Department IT IT Quality Assurance Quality Assurance
Annexure No.: CPL/QA/001/A01-00
 STANDARD OPERATING PROCEDURE
Title: OPERATING SYSTEM AND SECURITY POLICIES
SOP No.: CPL/IT/004 Page No.: 12 of 17
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 Each user will have network drive to store their data, which is not accessible by other users.
Network Drives will back up into Magnetic tapes.
 Data exported by the software (Empower, Lab X, etc.) will be stored in the network drive and
available to only respective users.
 The folders, which are used by multi user, shall have access by network drive and configuration
to the respective user in a predefined manner approved by head of the department.
1.100. Network connections settings
1.100.1. Network settings are configured for Network Connections for Security Purpose.
1.100.2. Disabled to rename LAN connections or remote access connections available to all users.
1.100.3. Prohibited access to properties of components of LAN connections.
1.100.4. Prohibited the TCP/IP advanced configurations.
1.100.5. Prohibited the enabling/disabling components of LAN connection.
1.101. Antivirus policy
1.101.1. For security of the data from the various viruses, ISD installed Antivirus software on Server
and all its client computers in entire network.
1.101.2. The definition of the antivirus shall be updated automatically by using the Antivirus server on
regular basis
1.102. Basic security and group policies.
1.102.1. User login account policies for the operating system.

Details Prepared by Reviewed by Approved by

Sign & Date
Name Krishnamurthy M K Veerendar Ch. Ramachandra Rao B. Suman Rao

Designation Manager Manager Senior Manager GM

Department IT IT Quality Assurance Quality Assurance
Annexure No.: CPL/QA/001/A01-00
 STANDARD OPERATING PROCEDURE
Title: OPERATING SYSTEM AND SECURITY POLICIES
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1.102.2. User name and password combination is unique for that particular user and it is the electronic
identification of that user.
1.102.3. Creation and deletion of user account is under the responsibility of IT.
1.102.4. Maintenance of user password is under responsibility of respective user with the help of IT.
1.102.5. For reactivation and missing password users have to consult IT.
1.102.6. IT is responsible for deactivate\disable the User account on his\her last working day.
1.102.7. Previous login user name shall not be visible at new login.
1.103. User privilege for operating system of computers
1.103.1. Each user shall have a unique combination of user identification and password.
1.103.2. The password shall be confidential.
1.103.3. There are two types of common user groups
e. Administrator level
f. User level
1.104. General policies and privileges for the Administrator level users
1.104.1. The administrator level users shall have rights to access / modify / control all features of the
computer system.
1.104.2. IT personnel will have the rights to access administrator level.
1.105. General policies and privileges for the user level users
1.105.1. All the computer users of Cronus Pharma come under user level.

Details Prepared by Reviewed by Approved by

Sign & Date
Name Krishnamurthy M K Veerendar Ch. Ramachandra Rao B. Suman Rao

Designation Manager Manager Senior Manager GM

Department IT IT Quality Assurance Quality Assurance
Annexure No.: CPL/QA/001/A01-00
 STANDARD OPERATING PROCEDURE
Title: OPERATING SYSTEM AND SECURITY POLICIES
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1.105.2. Users are restricted to Copy, Paste, Delete any kind of electronic raw data files from raw data
storage folder of the application software generated by systems.
1.105.3. Computer lockout mechanism shall be configured to prevent unauthorized access to operating
system when system is ideal.
1.105.4. They cannot use CD writer / Floppy drive/ USB flash drives.
1.105.5. All the users by default will be the members of restricted users group.
1.105.6. They cannot change Date, Time and Time zone of the system.
1.106. Security policies
1.106.1. Password Policy
1.106.2. All passwords shall have a minimum number of six characters. Passwords must be complexity
(combination of alphabets and numbers).
1.106.3. Password shall not be copied by anyway.
1.106.4. Password will expire in 90 days.
1.106.5. Passwords shall not be repeated for at least 3 changes.
1.106.6. During first login, system will ask to change the password given by the IT personnel.
1.106.7. Folder level security policy
 Each user will have network drive to store their data, which is not accessible by other users.
Network Drives will back up into Magnetic tapes.

Details Prepared by Reviewed by Approved by

Sign & Date
Name Krishnamurthy M K Veerendar Ch. Ramachandra Rao B. Suman Rao

Designation Manager Manager Senior Manager GM

Department IT IT Quality Assurance Quality Assurance
Annexure No.: CPL/QA/001/A01-00
 STANDARD OPERATING PROCEDURE
Title: OPERATING SYSTEM AND SECURITY POLICIES
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 Data exported by the software (Empower, Lab X, etc.) will be stored in the network drive and
available to only respective users.
 The folders, which are used by multi user, shall have access by network drive and configuration
to the respective user in a predefined manner approved by head of the department.
1.107. Network connections settings
1.107.1. Network settings are configured for Network Connections for Security Purpose.
1.107.2. Disabled to rename LAN connections or remote access connections available to all users.
1.107.3. Prohibited access to properties of components of LAN connections.
1.107.4. Prohibited the TCP/IP advanced configurations.
1.107.5. Prohibited the enabling/disabling components of LAN connection.
1.108. Antivirus policy
1.108.1. For security of the data from the various viruses, ISD installed Antivirus software on Server
and all its client computers in entire network.
1.108.2. The definition of the antivirus shall be updated automatically by using the Antivirus server on
regular basis
4.1 SAFETY, HEALTH AND ENVIRONMENT:
4.2 Not Applicable.

5.0 ABBREVIATIONS:

Details Prepared by Reviewed by Approved by

Sign & Date
Name Krishnamurthy M K Veerendar Ch. Ramachandra Rao B. Suman Rao

Designation Manager Manager Senior Manager GM

Department IT IT Quality Assurance Quality Assurance
Annexure No.: CPL/QA/001/A01-00
 STANDARD OPERATING PROCEDURE
Title: OPERATING SYSTEM AND SECURITY POLICIES
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5.1 U : Research and Development

5.2 COA : Certificate of analysis
5.3 GTP : General Test Procedure
5.4 RM : Raw Material
5.5 IP : In-Process
5.6 PM : Packaging Material
5.7 FP : Finished Product
5.8 STP : Standard Test Procedure
5.9 QA : Quality Assurance
6.0 REFERENCES:
6.1 Document control system - SOP CPL/QA/007.
7.0 ANNEXURES / ANNEXURES:

S.No. Annexure / Annexure No. Title

SYSTEM LEVEL USER ACCESS CONTROLS
1 CPL/QA/073/F01-00
IN COMPUTER SYSTEMS
2 CPL/QA/073/F01-00 Hardware configuration of Computer System

3 CPL/QA/073/A01-00 Change History Sheet

END OF THE DOCUMENT

Details Prepared by Reviewed by Approved by
Sign & Date
Name Krishnamurthy M K Veerendar Ch. Ramachandra Rao B. Suman Rao

Designation Manager Manager Senior Manager GM

Department IT IT Quality Assurance Quality Assurance
Annexure No.: CPL/QA/001/A01-00
 STANDARD OPERATING PROCEDURE
Title: OPERATING SYSTEM AND SECURITY POLICIES
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Details Prepared by Reviewed by Approved by

Sign & Date
Name Krishnamurthy M K Veerendar Ch. Ramachandra Rao B. Suman Rao

Designation Manager Manager Senior Manager GM

Department IT IT Quality Assurance Quality Assurance
Annexure No.: CPL/QA/001/A01-00