Quality record number/version：QP11G03R04/5.
File Type Technical File Process Code /
File Number CE-I03B-018 File Version 1.0
Scope of Application FA-160,FA-100
Software Validation Report
Related Files
File Number File Name Version
File Status
File Approval
identification
Department Name Date
Author R&D Zhang Yun 2020.02.25
R&D Zhang Yong 2020.03.25
Reviewer
Approver R&D Wang Zheng 2020.05.13
Dispatch
department
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Revise Record
ECN/PCN Effective
Version Description of Revise Author
Number Date
1.0 / First version Zhang Yun 2020.05.13
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Table of Content
Revise Record..................................................................................................................................... 2
Section 1 Software Description......................................................................................................... 4
Section 2 Software Requirements Specification............................................................................ 6
Section 3 Architecture Design Chart................................................................................................ 7
Section 4 Software Development Environment Description.........................................................8
Section 5 Verification and Validation Documentation................................................................. 10
Section 6 Software Risk Evaluation............................................................................................... 15
Section 7 Revision Level History.................................................................................................... 16
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Section 1 Software Description
1.1 Purpose and Scope
This document gives a comprehensive overview of the Lateral Flow Immunoassay Analyzer
system features that are controlled by software, and describe the intended operational
environment.
1.2 Referenced Standard
IEC 62304:2006 Medical device software - Software life cycle processes
1.3 Device features controlled by software
Software features Note
The system will prompt the current
analytical test of the
Sample Test test status during the test , and the
sample
test finish uploading the LIS data
Setup the test item and Setup the test item and Sample Type according
Settings
Sample Type to the necessary ,otherwise affect the test result
Use the Calibration material
Monitor the machine
produced by Shenzhen Lifotronic
Calibration performance and find
Technology Co., Ltd., otherwise
the problem early
affect the Calibration result
Data query including delete all the
Inquire the patients’ data. If you want to delete all data,
Data Query
test result you need to open the “delete all
data”function in the system settings.
Setup the time,
automatic print,
System Setup correctly according to the
Generate Sample ID
Settings necessary
and other system
function
Operation / Test Environment
The description of the intended operation environment should include the following:
1) Program language: C language
2) Microprocessor: STM32F103VCT6
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3) Complier: Keil uVision4
4) Writer: SerialPort
5) Software Ver.: 01.00.00
The detail of the software please refers to the user manual.
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Section 2 Software Requirements Specification
2.1 Hardware requirement to software:
item Requirements
CPU Frequency 72MHz
ROM 256KB
RAM 48KB
2.2 Programming Language Requirements
1) Program language: C- language
2.3 Interface Requirements
Interface requirements generally include both communication between system components
and communication with the user such as:
Item Requirements
Power supply +12V
voltage
Input Current +4A
2.4 Software Performance and Functional Requirements
Item Requirements
Test Sample Test, display tests real-time status, LIS data upload
Query Query, delete print, browse the result of the test,, LIS data upload
Setting Setup the test type and dilution rate
System System settings, senior maintenance, test history, etc
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Section 3 Architecture Design Chart
Calibrati
on
Searc Return Select Syste
h Return Select m
Select Homep Return
Select age Return
Test Clock
Return Select
Select Return
Setup
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Section 4 Software Development Environment
Description
4.1 We defined 6 stages for the Lateral Flow Immunoassay Analyzer System software
development life cycle.
1) Define system requirements
2) Design
3) Verification and Validation
4) Installation
5) Maintenance
6) Surveillance and Decommission
4.2 Stage description
4.2.1 Define system requirements
The process owner is software development engineer in this stage. Software engineer need
to work with customer representative, sales, hardware engineer and QA as a team to define
the Software Requirements Specification (SRS).
The SRS shall be an input of Risk Management to be reviewed by risk management team.
The hazard of software shall be controlled.
4.2.2 Design
Software Engineer (SE) establishes the architecture of Lateral Flow Immunoassay Analyzer
System software firstly, reviewed and approved by R&D project team.
Regarding to the architecture of software, SE draft the document of models (Software
Development Specification, SDS).
SE writes the code of every module, integrate it as software. It will be tested on PC to debug
it.
4.2.3 Verification and validation
We install the software in the Engineering Sample of Lateral Flow Immunoassay Analyzer
System; verify the following function of software:
1) Installation of software in embedded system.
2) Performance.
The verification result will be approved by customer representative as validation. The result
please refers to the document on Section 5.
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4.2.4 Installation
Verify the software installation to embedded system.
4.2.5 Maintenance
Any change of the Lateral Flow Immunoassay Analyzer System software, such as
configuration, code or function shall be reviewed and verified. The change of history and
reversion will be recorded.
So far, Lateral Flow Immunoassay Analyzer System change record is as following:
Date Change Rev
4.2.6 Surveillance and Decommission
Regarding the post production surveillance requirements, customer feedback related with
software will transfer to SE according to company’s vigilance system. SE shall Test the
customer complaints on software, such as the bug, error and unreason breakdown. And SE
needs to revise the software according to the complaints and Risk Management result.
The software will be used until Lateral Flow Immunoassay Analyzer System stop production.
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Section 5 Verification and Validation Documentation
5.1 Verification and Validation plan
In this process we will verify the following functionalities:
Item Requirements
Test Sample Test, display Test real-time status, LIS data upload
Search Query, delete print, browse the result of the test,, LIS data upload
Setup Setup the test type and dilution rate
System System settings, senior maintenance, test history, etc
5.2 Tested by: XXXXXX
5.3 Sample: Lateral Flow Immunoassay Analyzer system V01.00.00
5.4 Test Date：2013-XX-XX
5.5 Test Procedure and Setting
1)、 Turn on the power switch —〉Swiping card—〉The instrument tenter the main menu
interface—〉Click on the "Test" into the sample Test interface
Put test strip added sample in the test channel;
Press the start button on the LCD, to start the Test of the test channel;
Waiting for Test to finish, the LIS data upload automatically.
2)、Click on the "Query" button to enter the data query interface
Click on the "previous/next page" button can query data up and down;
Click on the "delete" button to delete the current sample information;
Click on the "delete all" button to delete all the sample information;
Click on the "print" button to print the current sample information;
Choose a line sample data, can upload the LIS data;
Input "sample number"/" date ", according to the number"/" by according to the date "can
inquire samples.
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3）、Click on the " Setting " button to enter project parameters settings interface
Click on the "Sample type", Choose Serum，Plasma or Whole Blood test mode;
Click on the "Test item", Choose PCT，CRP or CTnI as test item.
4）、Click on the " System " button to enter system settings interface
Click "system settings", and sets the system time, automatic print and other system
parameters;
Click on the " senior maintenance”, input the correct password, enter the senior
maintenance interface, test and check the hardware status;
Click on the "System state”, check the state about the whole system;
Click on the "manufacturer information", check the manufacturer information and contact
details;
Click on the "about", check the software version and models, and the copyright
statement.
The specific steps to see the table below：
5.6 Testing Result
Items/ Requirement + test Due Result Result—Remar Verdic
functions setting k t
1、Analyze the sample 1、analyze 1、 analyze
which is put into test strip normally normally
in the channel 2、setup normally 2、setup
2、Setup the sample 3、change normally
number of current normally 3、change
Sample sample ,bar code guns 4、operate normally
P
Test scan or manual input normally 4、operate
3、change the Test 5、display data normally
sample types and operate 5、display data
4、During the Test, all normally and operate
operations can be 6、print normally normally
operated but the 7、after finishing 6、print normally
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Items/ Requirement + test Due Result Result—Remar Verdic
functions setting k t
maintenance and Test, data will be 7、after finishing
calibration uploaded Test, data will be
5、 After finishing Test, normally uploaded
the results of sample normally
Test can be queried in
the query page
6、If automatic printing
is set , the system will
print the test report after
finishing Test
7、The LIS data will be
uploaded
1、The first page: 1、 display
1、display
display the latest 4 normally
normally
records 2、display
2、display
2、The next normally
normally
page:backward browse 4 3、query
3、query normally
records normally
4、the current
3、The previous page: 4、the current
records are
forward browse 4 records are
Data deleted P
records deleted
Query 5、delete all the
4、Delete: delete the 5、delete all the
records are
currently selected records are
deleted
records deleted
6、print normally
5、Delete all: delete all 6、print normally
7、return
the records 7、return
normally
6、Print: print the normally
8、upload the
currently selected 8、upload the
data normally
records data normally
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Items/ Requirement + test Due Result Result—Remar Verdic
functions setting k t
7、Query: query
according to the number
and time
8、Select an item,
upload the LIS data
1、Setup the sample
types: hypersensitivity 1、setup types 1、setup types
Serum，Plasma or Whole normally normally
P
Setting Blood 2、setup test item 2、setup test
2、Choose PCT，CRP or normally item normally
CTnI as test item
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Items/ Requirement + test Due Result Result—Remar Verdic
functions setting k t
1、System settings:
setup the system time,
1、setup
printer, etc 1、setup normally
normally
2、Senior maintenance: 2、display
2、display
need a password to hardware
hardware
enter, maintain the parameter
parameter
machine hardware and normally and the
normally and the
performance machine state is
machine state is
3、Calibration:find the normal
normal
potential problem early 3、Calibration
3、Display P
System 4、System state: display normally
normally
the temperature,battery 4、display
4、display
state ect statistics curve
statistics curve
5、Manufacturers normally
normally
information: display 5、display
5、display
manufacturer information normally
normally
and contact details 6、display
6、display
6、About: software normally
normally
version and copyright
statement
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Section 6 Software Risk Evaluation
Refer to A8: Risk management report.
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Section 7 Revision Level History
The following is the software revision level history of the Lateral Flow Immunoassay
Analyzer system.
Date Change Review
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