Vanta Bioscience (VBS) Plot No.

K2, 11th Cross Street, SIPCOT Industrial Complex, Gummidipundi-601 201, India

SOP

Title: Operation of Computerized Systems and Responsibilities of Personnel

SOP No.: VBS/ITS/001 Valid Since: Version Number: 01 Review Due Date: Revision Number: 00 Page No: Page 1 of 7

SIGNATURES I assure that I have authored this SOP according to applicable requirements of our company procedures. Author Name: Signature: Date: I assure that I have reviewed this SOP and find that it meets all applicable quality requirements and company standards. Reviewer (Quality Assurance Unit) Signature: Date: I assure that I have reviewed this SOP, and find it meets all applicable requirements and that it reflects the procedure Approver (Test Facility Management) described. I approve it for use. Name: Signature: Date: Name:

Unauthorized copying of this document is prohibited

SOP
1. 2. 3. 4. 5. 6. 7. 8. 9.

Title: Operation of Computerized Systems and Responsibilities of Personnel

SOP No.: VBS/ITS/001 Valid Since: Version Number: 01 Review Due Date: Revision Number: 00 Page No: Page 2 of 7

Table of Contents
Purpose ........................................................................................................................................................3 Scope ...........................................................................................................................................................3 Safety Precautions .......................................................................................................................................3 Abbreviations................................................................................................................................................3 Definitions.....................................................................................................................................................4 Responsibilities ............................................................................................................................................4 Procedures ...................................................................................................................................................4 Illustrations / Diagrams / Flow Charts ...........................................................................................................7 References ...................................................................................................................................................7

10. Change History.............................................................................................................................................7 11. Annexures ....................................................................................................................................................7

Unauthorized copying of this document is prohibited

SOP
1. Purpose

Title: Operation of Computerized Systems and Responsibilities of Personnel

SOP No.: VBS/ITS/001 Valid Since: Version Number: 01 Review Due Date: Revision Number: 00 Page No: Page 3 of 7

Purpose of this Standard Operating Procedure (SOP) is to describe the procedures for operation of computerized systems and responsibilities of personnel. 2. Scope The scope of this SOP is to provide procedures for the operation of computerized systems and the responsibilities of the personnel involved with it. This SOP is applicable to all laboratories and departments of Vanta Bioscience (VBS). The following list of software to be used for computerized systems in Vanta Bioscience. i) ii) iii) iv) Email Statistics Programs Lab Equipment Lotus Notes 8.0.2 MS Office 2010 NCPS Scoda Application Package -

3. Safety Precautions Security of VBSs Electronic Data and IT hardware protects VBS resources. All electronic Data on VBS Equipment or peripherals connected to VBS Equipment is VBS property and is subject to inspection, disclosure, scheduled retention and disposition. Employees should have no expectation of privacy in their use of VBSs resources for storing electronic Data unless otherwise provided by law. Each employee of VBS is responsible for the security and protection of electronic Information resources over which he or she has control or access. Resources to be protected Include networks, computers, software, and data. The physical and logical integrity of these Resources must be protected against threats such as unauthorized intrusions, malicious Misuse, or inadvertent compromise. Activities outsourced to off-site entities must comply with the same security requirements as in-house activities 4. Abbreviations SOP - Standard Operating Procedure VBS - Vanta Bioscience

Formatted: Indent: Left: 0.3", First line: 0"

Unauthorized copying of this document is prohibited

SOP
5. Definitions

Title: Operation of Computerized Systems and Responsibilities of Personnel

SOP No.: VBS/ITS/001 Valid Since: Version Number: 01 Review Due Date: Revision Number: 00 Page No: Page 4 of 7

Basic system configuration for user PCs will not be below an I5 Processor and Minimum 2GB. 6. Responsibilities 6.1. The authors are responsible for ensuring that all the procedures are written in accordance with this SOP. 6.2. All employees are responsible for ensuring the compliance with this procedure. 6.3. IT Support team is responsible for the first level support for the softwares installed in the system and will escalate to other IT teams or outside vendors as needed. 7. Procedures 7.1. The process of operating the computerized systems in IT department is defined as below: 7.2. Scientific Report Preparation 7.3. The R&D will be responsible for preparing the study plan against the request by the study director. 7.4. The Document Specialist will receive the raw data for compilation / statistical analysis (SOP/STA/001) from different study directors along with report requisition form (FRM/ITS/001) and the same will be distributed to the data entry operators for the report generation. 7.5. The generated report with raw data will be handed over to the person In-charge of documentation for verification. 7.6. Once the verification is completed the same will be handed over to the corresponding Study Director via a secure file system
7.7. The Study Director will check the draft copy of the report for any correction before the report is

finalized. 7.8. Once, the Study Director confirms the content of the draft report, the final draft copy of the report will be taken and sent to the corresponding Study Director. 7.9. If there is any correction after QA audit, then the same will be incorporated and the report will be finalized.

Unauthorized copying of this document is prohibited

SOP
7.10.

Title: Operation of Computerized Systems and Responsibilities of Personnel

SOP No.: VBS/ITS/001 Valid Since: Version Number: 01 Review Due Date: Revision Number: 00 Page No: Page 5 of 7

Other Activities: 7.10.1. The department will receive other miscellaneous works from HOD's, Senior Scientists and scientists for any publication/scientific purpose. 7.10.2. The department will collect the data for preparation of PowerPoint slides, excel sheets and Technical literature. Microsoft Powerpoint For Presentation purpose Microsoft Excel Microsoft Word Adobe PDF reader i) ii) iii) i) ii) iii) iv) - For technical data write up - For documentation - For accessing pdf files

7.10.3. Hardware/Software Installation, validation, up gradation done by IT Support person System installation System validation Hardware upgradation Backup will be taken via LTO4 device based on the data available in this server Daily backup will be scheduled in the server by 11 PM The Tape capacity will be 400GB and separate tape will be used in daily Every month data will be moved in separate tape and kept in the archive room.

7.10.4. Backup and restoration of data.

7.10.5. Collecting and processing data from meteorological station in the test facility.
Formatted: Heading 1, Left, Line spacing: single, No bullets or numbering, Tab stops: Not at 1.13"

7.10.5. 7.11. Department Personnel 7.11.1. The Department Staff will be designated by the management and they consist of IT Support Manager and IT support team. 7.12. IT In-charge 7.12.1. IT In-Charge has the following duties and responsibilities.

Unauthorized copying of this document is prohibited

SOP

Title: Operation of Computerized Systems and Responsibilities of Personnel

SOP No.: VBS/ITS/001 Valid Since: Version Number: 01 Review Due Date: Revision Number: 00 Page No: Page 6 of 7

7.12.2. Overall responsibility for IT support team, which maintains the systems and Hardware/Software purchase, Installation, validation, up gradation and development System maintenance, security, Annual Maintenance Contract and follow-up 7.12.3. Ensuring that Backup and recovery of data is completed 7.12.4. Ensuring that Training the staff in the IT field 7.12.5. Allocating work schedule for IT support team for their day-to-day activities. 7.12.6. Administering the overall department for its regular functioning 7.12.7. Network Administration, user creation, alteration and removal 7.12.8. Security of all IT systems for access to physical security 7.12.9. Scientific report preparation 7.12.10. Preparation of IT departmental SOP's.
7.13. VBS data entry personnel

7.13.1. Raw data entry for compiling scientific report. 7.13.2. Preparation of Study Plan and forms. 7.13.3. Scientific report preparation 7.13.4. Other works such as filing, maintenance of records etc. 7.14. IT Support team member IT Support team member has the following duties and responsibilities. 7.14.1. New user setup 7.14.2. Security for IT systems 7.14.3. Maintenance of IT systems 7.14.4. Fixing issues from IT systems and tracking such issues 7.14.5. Purchase of IT equipment and installation and upgrading of systems 7.14.6. IT Training 7.14.7. IT system validation for technical portions on new IT systems 7.14.8. Taking daily network backup on to the external backup device 7.14.9. Taking backup of Study Plan and Reports on to the CD-R for archiving purpose. 7.14.10. Restoration of backup files.

Unauthorized copying of this document is prohibited

SOP
Nil 9. References Nil 10. Change History Version No. 01

Title: Operation of Computerized Systems and Responsibilities of Personnel

SOP No.: VBS/ITS/001 Valid Since: Version Number: 01 Review Due Date: Revision Number: 00 Page No: Page 7 of 7

8. Illustrations / Diagrams / Flow Charts

Revision No. 00

Effective Date First issue

Details of change(s) incorporated

11. Annexures Nil

Unauthorized copying of this document is prohibited