Vbs Sop Its-002 Dv01 04 May 11 Ms

Vanta Bioscience (VBS) Plot No.
K2, 11th Cross Street, SIPCOT Industrial Complex, Gummidipundi-601 201, India
SOP
Title: Installation, Validation, Acceptance, Upgrading and Maintenance of Hardware and Software
SOP No.: VBS/ITS/002 Valid Since: Version Number: 01 Review Due Date: Revision Number: 00 Page No: Page 1 of 14
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.
Table of Contents
Purpose ........................................................................................................................................................3 Scope ...........................................................................................................................................................3 Safety Precautions .......................................................................................................................................3 Abbreviations................................................................................................................................................3 Definitions.....................................................................................................................................................3 Responsibilities ............................................................................................................................................3 Procedures ...................................................................................................................................................3 Illustrations / Diagrams / Flow Charts ...........................................................................................................4 References ................................................................................................................................................. 13
10. Change History........................................................................................................................................... 13 11. Annexures .................................................................................................................................................. 13
SOP
1. Purpose
Purpose of this Standard Operating Procedure (SOP) is to describe the procedures for installation, validation, acceptance, upgradation and maintenance of hardware and software. 2. Scope The scope of this SOP is to provide procedures for the installation, validation, acceptance, upgradation and maintenance of hardware and software of computer systems. This SOP is applicable to all laboratories and departments of Vanta Bioscience (VBS) 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 5. Definitions Basic system configuration for PC users will be at a minimum 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.
SOP
7. Procedures
6.2. IT department personnel are responsible for ensuring the compliance with this procedure.
7.1. Classification of systems 7.2. The computer systems at test facility will be broadly classified in to 9 categories. 7.2.1. Data capture systems 7.2.2. Laboratory systems 7.2.3. Data processing systems 7.2.4. Order processing systems (M3) 7.2.5. Communication systems (email, VoIP, etc.) 7.2.6. Networking systems 7.2.7. Backup systems 7.2.8. Power supply systems 7.2.9. Security, access control, directory services systems 7.3. Data Capture Systems 7.4. These systems are meant to receive data by online of in-life data of animals during experiment. 7.4.1. The equipment used for this purpose are: 7.4.2. Computers connected with server 7.4.3. Balance connected with computers 7.5. Data Processing Systems 7.5.1. Data processing systems will be used to analyze the data during the experiment by online and will be used to prepare the documentation for submission to regulatory authorities. 7.5.2. The equipment used for this purpose are: 7.5.3. Computers connected with server 7.5.4. Printers connected with computers 7.5.5. Scanners connected with computers 7.5.6. Network printer connected with switch 7.6. Communication Systems 7.6.1. Communication systems will be used to transmit the data between PCs and servers. Unauthorized copying of this document is prohibited
SOP
7.6.2. These are critical equipment where the systems are intended for transmitting the experimental data collected by on-line from the experimental site. 7.6.3. The devices used for the communication purpose are classified in to: 7.6.4. Networking switch, Routers, 7.6.5. Ethernet cards, Cables 7.7. Backup Devices 7.7.1. Backup devices will be used for taking backup of all the data collected during the experiment, processed and documented. 7.7.2. The devices used for this purpose are: 7.7.3. Disk mirroring/RAID controlled disk arrays 7.7.4. CD-R 7.7.5. Tape 7.8. Power Supply Equipment 7.8.1. Power supply equipment will be used to supply the required power for equipment. 7.8.2. The systems are categorized in to: 7.8.3. Uninterrupted Power Supply (UPS) 7.8.4. Stabilizers 7.9. Installation, Upgrading and Maintenance of Hardware Systems Procedure 7.9.1. Hardware Installation Procedure 7.9.2. The nature of hardware and under which category it will be used at test facility, will be identified as per item 7.1. 7.9.3. The installation manual and the list of enclosures provided by the manufacturer will be read carefully. 7.9.4. If required, individual parts will be checked and made sure that it functions properly before being connected to the main systems. 7.9.5. The power supply sources will be checked for proper functioning and will be analyzed for adequate power supply. 7.9.6. The individual systems will be connected one by one.
SOP
7.9.7. The following are the specific procedures for each type of systems. The installation report will be entered in the proforma (FRM/ITS/024). 7.9.8. Data Capture Systems 7.9.9. The data capture systems are usually asynchronous devices, which may work in analog signals 7.9.10. Data Processing Systems 7.9.11. The data processing systems are usually synchronous devices, which will work like host systems and connect the devices prescribed by the manufacturer's guide or user manual. 7.9.12. If it is an input device, make sure the given input reaches safely to the host system. 7.9.13. If it is an output device, check the status of output. 7.9.14. Take the test page, if it is a printer/Xerox and include it in the installation report. 7.9.15. Communication Systems 7.9.16. The communication devices are most critical path in the computer-based systems to transmit the data from source to destination without affecting the integrity of the transmitted data. 7.9.17. Ensure the Fiber optic connection between site and provider is working. 7.9.18. Ensure the primary and backup connectivity is available for transferring data in required time. 7.9.19. If the conductivity test is successful, then connect the devices and transmit some test data and check the transmitted data in destination. 7.9.20. Record all the details in Computer Work Sheet (FRM/ITS/002). 7.9.21. Backup Device 7.9.22. The backup device will be used to perform regular checking of system and taking backup of all the important data stored in the computer. 7.9.23. The backup device will be installed as per the prescribed procedure given by the manufacturer. 7.9.24. The media used to take the backup are usually magnetic media and the surface test will be performed before being put into use. 7.9.25. Power Supply Equipment
SOP
7.9.26. The power supply equipment will be installed with the help of qualified electrical engineers as it involves handling of voltage directly or indirectly. 7.9.27. The equipment such as UPS and stabilizers are selected in such a way to suppress the spikes and surges. (range) 7.9.28. If a stabilizer is installed, then the input as well as the output voltage shall be checked. The frequency is set to be 50 Hz. 7.9.29. The details will be entered in the Working Sheet of the equipment (FRM/ITS/002). 7.9.30. Hardware Upgrading Procedure 7.9.31. While upgrading memory devices such as hard disk, RAM, a backup of old data will be taken on a CD and upgradation will be initiated. 7.9.32. The upgradation procedure supplied by the manufacturers of the hardware will be followed. 7.9.33. The device will be checked after upgradation and made sure that the device works perfectly as before. 7.9.34. In case the system doesn't work after upgradation, then the old configuration maintained in the computer inventory sheet will be restored. 7.9.35. The upgradation will be recorded in the Computer Work Sheet (FRM/ITS/002). 7.9.36. Hardware Maintenance Procedure 7.9.37. Maintenance procedure will be carried out as per the category of the system mentioned under item 6.1. 7.9.38. Specific procedure for the particular equipment will be followed as per the manufacturer's recommendations. 7.9.39. The maintenance of all the systems except new systems (all new systems have three year warranty and hence will be maintained by the supplier of the system for the 3 years) used in GLP is given to third party AMC (Annual Maintenance Contract). 7.9.40. The responsibilities of third party (AMC) are defined as follows: 7.9.40.1. Attending the problem reported by the test facility IT staff 7.9.40.2. Monthly PM (Preventive & Maintenance) 7.9.40.3. Spare parts replacement
SOP
7.9.41. Ensuring proper working of systems and necessary validation of hardware and software 7.9.42. However, the data stored in the computer will be maintained by the test facility IT staff and the third party AMC will not cover the stored data but they will have the responsibility of maintaining the storage devices to ensure that the data are stored and retrieved properly. 7.9.43. General Procedure to Maintain the System 7.9.44. All the computerized systems will be installed and maintained in a manner to ensure continuity of accurate performance. 7.9.45. The system will be installed in a location where it will not get affected due to high temperature, high voltage-passing area, nearby magnetic controlled device and fire oriented devices. 7.9.46. The Ultrim4 LTO device tape will be maintained as per the recommendations given by the manufacturers. 7.9.47. The UPS (Uninterrupted Power Supply) will be maintained in such a way that it will be given input voltage continuously for 24 h without any interruption if the power is present. However, there will be 4 5 Hours backup available in the UPS, if there is no power supply for a short period of time. 7.9.48. The responsibilities of IT In-charge for maintenance of Systems are defined as follows: 7.9.48.1. Remains the overall responsibility of the system maintenance. 7.9.48.2. If any problem is reported through computerized systems problem reporting form (FRM/ITS/003), the In-charge will check the nature of problem and accordingly it will be informed to the third party AMC. 7.9.48.3. If the system needs follow-up in the rectification process, then the IT In-charge has the responsibility of keep track of the problem solving. 7.9.48.4. The identification, assessment and selection of third party AMC will be done by the IT In-charge with prior approval from the management. 7.9.48.5. The complaint by the IT In-charge and service report given by the third party AMC will be documented. 7.9.48.6. Once problem attended the same will be document in the proforma
SOP
SOP No.: VBS/ITS/002 Valid Since: (FRM/ITS/021). Version Number: 01 Review Due Date: Revision Number: 00 Page No: Page 9 of 14
7.9.49. General Operation of systems 7.9.50. System will be switched on and the instruction displayed on the output device will be followed. 7.9.51. If anything goes wrong while the system is functioning, it will be reported to the In-charge. 7.9.52. Computer systems with input and output devices 7.9.53. The systems with minimum input such as keyboard and mouse, output devices such as printer and display unit will come under this category. 7.9.54. During the booting process the system will check the input and out put devices by glowing the light in keyboard and printer. 7.9.55. Then the user will be prompted to enter the password before booting. 7.9.56. Communication Systems 7.9.57. All the communication systems are automatic and no user intervention is needed for regular work. There is no manual operating part in the communication systems like switches, routers cables (UTP, fiber) 7.9.58. Backup Devices 7.9.59. The backup devices such as external drives or Tapes will be used by the backup-operators. 7.9.60. Before taking the backup on external drives and tapes, the integrity of the media will be checked.. 7.9.61. For taking backup in to a CD, CD burning software will be used. 7.9.62. Power supply systems 7.9.63. Power supply systems are source systems to the computers. It will be ensured that the power supply systems are kept in safe places. 7.9.64. The UPS/Stabilizer will be switched on using the switch on the front panel. If the power supply system is having the front panel display, the input and output voltage will be checked. The input voltage shall be 220 10 Volts and the output voltage shall be 225 5 V. 7.9.65. Validation Procedure for Hardware Systems 7.9.66. Computer system requirements will be prepared and reviewed by the IT In-charge.
SOP
7.9.67. A validation team headed by the IT In-charge will validate the computer systems based on the Validation Master Plan and a system validation review approval form will be raised through computerized systems problem reporting form (FRM/ITS/003). 7.9.68. The acceptance certificate for hardware will be prepared (FRM/ITS/022). 7.9.69. The periodicity of validation will be carried out once in a year. 7.9.70. Classification of software 7.9.71. The computer software at the test facility will be broadly classified in to 7 categories: 7.9.71.1. Operating Systems Windows 7, Windows 2008 Server 7.9.72. Data capture systems 7.9.73. Laboratory systems 7.9.74. Data processing systems 7.9.75. Order processing systems (M3) 7.9.76. Communication systems (email, VoIP, etc.) 7.9.77. Networking systems 7.9.78. Backup systems 7.9.79. Power supply systems 7.9.80. Security, access control, directory services systems 7.9.80.1. Word Processing Software 7.9.80.2. Spread Sheet Software 7.9.80.3. Presentation Software 7.9.80.4. Statistical Analysis Software 7.9.80.5. Utilities and Internet Software 7.9.80.6. The complete inventories of all the software, including in-house software's used at test facility will be given in Computer Software Inventory Sheet (FRM/ITS/009). 7.9.81. Operating Systems 7.9.82. Systems and control the input and output devices. The operating systems that are used in the test facility are Windows 7, Windows 2008 Server.
SOP
7.9.83.
7.9.84. Word Processing Software 7.9.84.1. Word Processing software will be used to prepare the scientific documents at test facility. Software like MS-Word will be used for preparing various documents. 7.9.85. Spread Sheet Software 7.9.85.1. The spreadsheet software will be used to prepare additional calculations for scientific reports. The software MS-Excel is used for this purpose. 7.9.86. Presentation Software 7.9.86.1. MS- Power Point will be used to make the presentation slides for conference, meeting, training and seminars. 7.9.87. Statistical Analysis Software 7.9.87.1. The statistical analysis software is used to analyze the data collected from experiments at test facility. In all the experiments the statistical methods will be used to analyze the data for the significance or the survival rate. 7.9.87.2. Software such as SPSS and NCSS 2000 will be used to analyze the data by the statistician. Apart from this software, there is in-house developed software like Probit, Pro which will be used to carryout statistical analysis. 7.9.88. Utilities and Internet Software 7.9.88.1. Maintenance of hard disk, taking backup of systems files and virus protection. The Internet Explorer will be used for the Internet applications. 7.9.89. Software 7.9.89.1. The nature of the software and to which category it belongs will be checked first. 7.9.89.2. The installation manual will be carefully read and the Operating system that can accommodate the software will be checked. 7.9.89.3. The memory size of the new software and the free disk space will be checked. 7.9.89.4. A separate new directory name will be assigned for the software to be installed. 7.9.89.5. If the software is so complicated to install, a detailed training about the installation of software will be requested from the supplier.
SOP
7.9.89.6. If a new operating system is getting installed, then backup of old files will be taken safely on a CD. 7.9.89.7. After installation of software, the readme. txt file shipped along with the software will be read carefully. 7.9.89.8. If a third party is installing software, then an installation report from the concerned people will be requested. 7.9.89.9. The software installation in the server will be avoided during the working hours of the test facility, since some software needs server to be restarted after the installation and it will affect the remote nodes connected to the server. 7.9.89.10. After the successful completion of the installation of the software, computer software inventory list will be updated along with the acceptance certificate (FRM/ITS/023). 7.9.90. Upgradation 7.9.90.1. Before upgradation of any software, backup of old versions and its data will be taken safely on CD/Backup device. 7.9.90.2. The upgradation manual will be read carefully and the same procedure will be followed. 7.9.90.3. After the successful completion of the installation of the software the changes will be recorded in the Software Inventory List. 7.9.91. Precautions 7.9.92. Precautions to remember while using the software: 7.9.92.1. The configuration files that are stored will not be changed. 7.9.92.2. The first time use of any software will be assisted by experts. 7.9.92.3. If anything goes abnormal with software while working, it will be immediately informed to the In-charge. 7.9.92.4. On-line help for the software will be referred for any assistance. 7.9.92.5. The Fl function key is usually the help command in any window-based software. 7.9.92.6. No files will be deleted without consulting the responsible personnel.
SOP
7.9.92.7. Always currently working files will be saved. 7.9.92.8. If the software is menu based short-cut keys will not be used unless otherwise they are very familiar. Some time, combination key will lead to damage of system or other files. 7.9.93. Validation of Software 7.9.93.1. Vendor Supplied 7.9.93.2. Vendor-supplied software will be reviewed by the IT In-charge based on the requirements. 7.9.93.3. A validation team will validate the software based on functional specifications given in the Validation Master Plan. 7.9.93.4. A software validation approval document will be prepared. 7.9.93.5. Based on software validation approval, the acceptance certificate for the software will be prepared. 7.9.93.6. Validation Team 7.9.93.7. QA Personnel, Management, if need one member from the IT and AMC/Third party. 7.9.93.8. Based on the validation protocol, the qualification document and validation report will be prepared. 8. Illustrations / Diagrams / Flow Charts Nil 9. References Nil 10. Change History Version No. 01 Revision No. 00 Effective date First issue Details of change(s) incorporated
SOP
11. Annexures Nil

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Vanta Bioscience (VBS) Plot No.

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