SOP FOR INFORMATION TECHNOLOGY AND DATA MANAGEMENT IN THE LABORATORY
1.0 Purpose:
To ensure effective maintenance of if systems for trouble-free operation of all the peripherals and LIS Installed in the laboratory
including upkeep and management of the same to protect data from Infringement,
loss, and easy retrieval
2.0 Scope:
The scope of this procedure covers the availability, maintenance, and calibration of the following
a. Computers including peripherals
b. IT and the LIS System
3.0 Reference:
Quality System Manual.
Details:
4.1 Computer Systems & Peripherals Commissioning and
Decommissioning
4.1.1 ResearchNeeds provides computer systems and
peripherals depending on the use/requirement of the personnel. The type and
configuration of the system are decided based on the requirement of the user and
is approved by the Director.
4.1.2 It is the responsibility of the IT- Personnel to make the
management aware of the latest systems and current software packages available
in the market.
4.1.3 A List of all computers and peripherals Installed at
ResearchNeeds is prepared and maintained by IT personnel. All the computers and
peripherals are uniquely numbered for the purpose of Identification this list
is revised when the new system is added or the old system is removed. The list also
includes any additional privileges given to any user like internet of purchased
software etc.
4.1.4 Decommissioning of the System: In case of any system is
faulty or not as per the required configuration. The same is informed to the IT
section. If the section would analyze the system and cost Involved in the repair/
upgrade of the system and present it to the management. After approval, the same
is repaired/ upgraded. In case the repair / up gradation cost is not justified
or the system is beyond repairs, the decision is taken to dispose of the system and
purchase a new system.
Log of IT asset is maintained by the if section along with
details of decommissioning if any in the format.
4.2 Preventive Maintenance & Breakdown servicing of Installed
Computers & Peripherals:
4.2.2 Maintenance of computers and peripherals is the prime
responsibility of outsourced form. The routine maintenance of Installed
computers is taken care of by a visiting engineer for the purpose. In case of any
breakdown, the user functional head Initiates the Company representative to rectify the
fault. In the absence of the visiting engineer assigned to ResearchNeeds, backup
personnel assigned by Progressive attends to the compliant/ breakdown call,
A log is generated
for every breakdown/complaint generated and rectification of the same in the
following format
CALL DETAILS
Case No.:
Log Date & time:
Log By:
User Email:
Phone/Ext No.:
Department:
COMPLAINT…….
Service Line: Severity:
Assigned To: Progressive Factory
Complaint Category:
Complaint Type: Case Detail:
CALL STATUS..........
Call Status:
Solution:
Comments:
4.2.3 In case any system or peripheral is sent outside the
premises for maintenance and repairs, a Gate Pass is Issued for the same. The
details of the receipt of the material are noted on the retained copy of the
Gate Pass.
4.2.4 Bench Work Instructions for Operation and. Maintenance
of the Instrument are available for easy reference of the staff along with the
Instrument Manuals
4.3 Data Security of Installed Computers and Peripherals
4.3.1 The computers are protected from unauthorized access
by the use of passwords that govern access limitation to Read. Write or Modify
functions. The passwords are updated regularly at an interval of 50 days and
are under the direct control of respective personnel to whom it is assigned in
a unit-specific manner. The system is configured to automatically prompt the
user to change passwords before 15 days of expiry. The passwords are defined by alpha-numeric characters. All the computer systems are configured for manual log-in and log-out.
4.3.2 All the computer systems are configured to
automatically limit the number of logins. The system gets locked in case the
login attempts exceed 5. The record of such failures is generated automatically.
4.3.3 Computers are used as standalone units of single-user
function and data from one computer cannot be accessed from another computer
unless any data is shared for specific use: This ensures that data/ Information
confidentiality is maintained at all times. All the computers are programmed
for auto lock within 2 minutes of the computer being ideal.
4.3.4 When an employee leaves an organization, their access to
software/ computer system is blocked following mall from HR. The details of the
handover are recorded in 'IT services form- ……… of the procedure manual-HR
4.3.5 Computer programs are checked for proper performance
when first Installed and after any changes or modifications. Any changes or
modifications to the systems are monitored on a regular basis by the IT section which
includes, but is not limited to unauthorized software installation, usage of
personal laptops, access to unauthorized websites, unauthorized data transfer, etc. For the internet security firewall is in place and unauthorized access is
not allowed.
4.3.6 All the routes of data transfer like USB Interface.
Floppy drives and CD drives are blocked by IT team. In case any port or
interface is opened for use like backup/ transfer of data, the same is
authorized by the respective section-in-charge and after the completion of work
same is again blocked. A record of any such event is maintained by the
personnel - IT systems.
4.3.7 Systems attached to any measuring Instruments / equipment sare maintained by the respective vendor for the Instrument, Care is taken to
Include all such major instruments under AMC.
4.3.8 It is the sole responsibility of the Section-in-charge to
take backup of the data stored in the systems attached to any instrument/
equipment. The schedule of the backup is decided based on the usage of the
system and the frequency of data generated. The backup is taken either in pen drive
or hard drives provided to respective section-in- charge for that matter. Apart
from taking back up on the hard drive a copy of the same is transferred to
"File server' allocated to each section-in-charge. A record of the same is
kept with each section-in- charge.
4.3.9 Any changes to the computer systems are restricted and
the laboratory director or designee approves all changes, additions and
deletions in programs, and major computer functions before they are released.
For any modification, requisition is accepted through written document either
in form of email or circular, Also, confirmation is taken from the originator
of change request. Record of any such communication is retained for at least
two years beyond the service life of the system.
4.3.10 Restricted entry to server room ensures prevention of
un authorized access to the server and related peripherals. Log of any person
visiting the server is maintained by the IT section
4.3.11 The laboratory maintains the disk space log when a
new system is issued to user. The capacity provided is ensured that it should
be enough to meet the need of user.
4.4 Laboratory Information System: Maintenance, Security and
Data Management
A Maintenance & Up gradation
Step wise Instructions for operation of Laboratory
Information System have been laid down for easy understanding and operation of
LIS apart from the User Manual provided by the vendor
4.4.2 The users are trained to use the LIS and in case of
any change or updating the software, same is communicated to all the users
either via circular or during training sessions, in house IT personnel are
trained by the vendor who in turn train the users
4.4.3 The up gradation and major maintenance is done by the
vendor Busy Soft' Minor maintenance and Inclusion of data like client list,
pricing and updating list of tests are done In-house by the IT section
4.4.4 All the users are given login ID and password specific
for them which they need to change before expiry. The access rights are defined
by respective section heads depending on their role in the dept.
4.4.5 Requisition for new test code and user ID in the US is
forwarded in the respective formats to the Head - Lab Systems after approval
from Lab Director. The Head-Lab Systems then verifies the correctness of
Information provided before generating a new test code or user ID and
authorized If personnel executes the same.
4.4.6 The users of the software are given security rights
depending on their role in the organization and the same is approved by SIC and
C.O.O before implementation: Accessioning team is given rights to perform
accessioning of patient data and orienting of reports. Technical team is given
rights for result entry and only SICs are authorized for report authentication
and modification in patient results. The e signatures are appended to the
report only after final authorization by the respective section in charge. The
e signatures are in secured format such that it cannot be copied in soft form
from the US Record of the authorized signatories is maintained by the IT
personnel along with areas specialized to which they are authorized
4.4.7 All the patient report before release are verified and
validated by respective section in charge to check the result against a defined
reportable range and critical results for the fest, and ensure that the
appropriate number of decimal places are present. Also during validation,
correctness of result entry is checked against the worksheet(s) of the patient.
For any unacceptable specimen, report is released with the comments on specimen
quality Auto-verification of reports is not done.
4.4.8 Any modifications and deletions are recorded automatically
by the software and con be verified by monitoring audit report gered bby the
software which das species the me and details of user and the system Proved Any
change in the entry is authorised by the respecte section in charge and Head
Lobi tystems the audi tras con only be generated by authorised if personnel and
of other uses are bored fom activity
B Downtime and Data Retrieval
4.4.9 Any issues related to software are communicated to the
Head Lab systems who in turn communicate the same to Bury Soft' in case of any
minor change in the software the vendor sends the e the via mall to head lab
systems and authorized personnel if the responsibility of to update the
excel file on systems of all the use A record of the some is maintained
4.4.10 Downtime is planned and documented via mail or
circular to minimize interruption of service the schedule of the downtime is
planned in off-work hours or at least-won hours. The delay in reporting if any is
informed to all customers during partial or complete downtime and recovery of
the system
4.4.11 After partial or complete shutdown and recovery of
systems, the dummy patient registration and reporting is done to ensure
complete recovery of data and ensure proper functionality of the software
Downtime register is maintained and the procedure of restoring & documenting.
4.4.12 In case of unscheduled downtime, if required, the
reports are released in Word/excel format to meet the set TAT
C Data Security
4.4.13 Unauthorized access to the server and inducement of any changes
& prevented by restricting access to the server room, A log of any
personnel visiting the server room is maintained in the absence of any if personnel in the server room a kept locked, Backup up key for emergency purposes available with
the security guard
D Data Back up and retrieval
4.4.14 Data back done daily, weekly basis and
monthly basis is maintained at the remote location to ensure the preservation of data
ResearchNeeds has an agreement with '………' and '…….’ to maintain and preserve dala
at the remote location. Daily and weekly Data back-up media/ mass storage drive is
sent to 'Rouse Avenue' dolly by the IT personnel, Monthly data back-up media/
mass storage drive for yearly retention is sent to ……IT's copy of the gate pass
is retained with I section. This procedure also helps in the preservation of
data and equipment in case of an unexpected destructive event leg., fire,
flood). software failure and/or hardware failure, and for The timely
restoration of service.
4.4.15 Once in a month, stored data is checked for its
completeness, For the same, one of the old patient reports, stored in backup
data is randomly selected and retrieved by if person and then it is cross-checked for its completeness Including patient demographic, final result,
Interpretive comments footnote, original reference ranges by Head lab systems.
The comparison is made with the report saved in current data and the log of the
same is maintained. Only when the two reports are the same, They are accepted. In
case of any discrepancy. The manufacturing team is Informed.
4.5 Environment Conditioning & General Upkeep
Management:
4.5.1 Suitable arrangements are planned and Implemented for
provision of good work environment & security provision by management. This
is to ensure following:
a. Sufficient space.
b. Latest and upgraded systems.
c. Safety of server room.
d. Optimized environmental conditions
e. Adequate back up.
f. Appropriate fire fighting equipments
g. Appropriate environmental conditions
4.5.2 Uninterrupted power supply: All servers, bench
desktops, laptops, printers are connected through Uninterrupted Power Supplies
to avoid any kind of surges and unconditioned power. The server room gets power
from UPS. The UPS is being monitored on regular basis.
5.0 List of Formats & Records:
List of computer/ peripherals and status
Requisition for generating New Test Code in US
Requisition for generating new User ID in LIS
log of weekly retention- daily back up Log of monthly
retention-weekly back up
log Yearly retention- monthly back up
Log-Temporary access to data transfer ports
Log-Up-gradation of the LIS
Log if data back-up from instruments and equipments
Log of personnel visiting Server Room
Record of List of computer/.peripherals and status
Record of Requisition for generating New Test Code in LIS
Record of Requisition for generating new User ID in LIS
Record of log of weekly retention- daily back up Record of
Log of monthly retention-weekly back up
Record of log Yearly retention-monthly back up
Record of Log-Temporary access to data transfer ports
Record of Log-Up-gradation of the LIS
Record of Log if data back-up from instruments and
equipments
Record of Log of personnel visiting Server Room
END OF THE DOCUMENT
1. List of All SOPs and Documents for In-vivo Laboratory
2. List of All SOPs and Documents for Study Protocol
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