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Software development of XXX
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T$829 &1 ,&.T9.TS
1 %ntrod#ction /
1.1 Document overview 3
1.2 Scope 3
1.3 Abbreviations and Glossary 3
1.4 References 3
1.5 onventions 3
7 Pro:ect (anagement ;
2.1 !eam " #uman resources 5
2.2 Responsibilities 5
2.3 ustomer $%ser involvement 5
2.4 !as&s " 'lannin( $ )ilestones 5
2.5 *n(ineerin( environment 5
2.+ ,t#er Resources 5
2.- Software life cycle model 5
2.. Reviews 5
2./ Software con0(uration mana(ement +
2.11 Documentation mana(ement +
2.11 2eri0cation +
/ Speci6cations <
3.1 States -
3.2 'erformance -
3.3 Safety3 security3 and privacy protection -
3.4 %ser maintenance -
3.5 %sability and #uman$factors en(ineerin( -
3.+ System environment -
3.- *4ternal interfaces -
3.. Resources .
3./ 5nternal data .
3.11 Adaptation .
3.11 2eri0cation .
3.12 'ersonnel and trainin( .
3.13 'ac&a(in( and installation .
4 $rchitect#re = ,onception >
4.1 Arc#itecture /
4.2 onception /
; Veri6cation 10
5.1 !est 'lan 11
5.2 !ests Description 11
? Tests )es#lts 17
+.1 Rationale for decision 12
+.2 Results 12
< )e@#irements tracea-ilit" 1/
Doc # Version: 01 Page / / 14
1 %ntrod#ction
$ummary:
This is the all-in-one template for soft#are de&elopment
This template doesn/t co&er the ris" management
1t is )lled incrementally during the pro2ect.
1 suggest incrementing the &ersion number #hen a chapter is full:
3e&1: chapter 1 4 2
3e&2: chapter 5 4
3e&5: chapter -
3e&: chapter 6
Chapter , is )lled in re&ision 1 and re&ision 2.
1.1 Document overview
This document contains the organi7ation* the speci)cations* the conception* and
&eri)cation tests of 888 soft#are de&elopment pro2ect.
1t co&ers the follo#ing goals:
888.
1.2 Scope
10701 %denti6cation
This document applies to the 888 de&ice9s: de&eloped in the 888 pro2ect.
10707 &verview
'ro2ect !&er&ie#
1.3 Abbreviations and Glossary
10/01 $--reviations
;dd here abbre&iations
10/07 Alossar"
;dd here #ords de)nitions
1.4 References
10401 Pro:ect )eferences
< %ocument
1denti)er
%ocument Title
=31> 1% ;dd your documents references.
!ne line per document
10407 Standard and reg#lator" )eferences
< %ocument
1denti)er
%ocument Title
=$T% ;dd your references
1>
1.5 onventions
3e?uirements listed in this document are constructed according to the follo#ing
structure:
)e@#irement %d
Requirement title
3e?uirement description
3e?uirement &ersion
@Aample:
S)S!XXX!000
Title of XXX-000 requirement
%escription of 888-000 re?uirement
Bersion of 888-000
Typographical con&ention.
;ny other con&ention.
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7 Pro:ect (anagement
Cor each of the sub-sections* if you already ha&e a $!' in your DM$ that co&ers
the topic* add a reference to the $!'* and a little eAplanation if necessary.
The section describes the organi7ational structure of the 888 pro2ect.
2.1 !eam " #uman resources
The team is described in the diagram belo#.
1nsert diagram of organi7ation
2.2 Responsibilities
The team of the pro2ect has the follo#ing responsibilities:
Technical (anager: 888
Pro:ect (anager: 888
XXX
2.3 ustomer $%ser involvement
%escribe ho# the end user is in&ol&ed in the soft#are de&elopment: meetings*
re&ie#s* and presentations of intermediate &ersions E
The customer may or may not be the end-user
2.4 !as&s " 'lannin( $ )ilestones
The planning belo# contains all tas"s of the pro2ect and the lin"s bet#een tas"s.
1nsert a table or list or diagram describing the planning.
2.5 *n(ineerin( environment
Fhat "ind of #or"station / ser&er do you use and e&ery other hard#are.
2.+ ,t#er Resources
1f speci)c resources are need for the pro2ect such as a calibrated measurement
tool or a simulator* they shall be identi)ed* referenced and managed in
con)guration.
1f not* add the follo#ing sentence
There is no particular resource needed for the pro2ect such as a calibrated
measurement tool or a simulator. +ence* no speci)c identi)cation of resources is
needed for the pro2ect* the hard#are and soft#are resources are interchangeable
C!T$.
2.- Software life cycle model
Faterfall / 3G' / ;gile* ?uote your model
2.. Reviews
The pro2ect begins #ith a launch re&ie# and ends #ith a )nal re&ie#.
T#o types or re&ie#s occur during the pro2ect:
%esign 3e&ie#s
Tests 3e&ie#s
2a#nch )eview is a formal* documented and systematic meeting during #hich
the pro2ect team members get ac?uainted #ith the goals of the pro2ect and all
other information contained in the management plan.
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Design )eviews are formal* documented and systematic meetings during #hich
the current design of a product 9system* sub system etc.: is re&ie#ed and
compared #ith the re?uirements. %esign 3e&ie#s are scheduled in the pro2ect
planning. The ob2ecti&e of %esign 3e&ie#s is to critically appraise the design and
de&elopment in accordance #ith the re?uirement* and to con)rm and appro&e
technical aspects.
Test )eviews are formal* documented and systematic meetings during #hich
the current design of a product is tested. Tests re&ie#s are scheduled in the
pro2ect planning.
1inal )eview is a formal* documented and systematic meeting during #hich the
'resident/'ro2ect manager/any other &alidates the 888 product 9see &alidation
process in soft#are ?uality assurance plan ref. 8:. The re&ie# contains also a part
de&oted to the return on eAperience on progress of the pro2ect and on the
processes used during the pro2ect.
2./ Software con0(uration mana(ement
%escribe con)guration management: #hat tool do you use. Fhat are the
repositories 9eg:#or"* integration* deli&ery* )nal:.
2.11Documentation mana(ement
%escribe ho# documents are identi)ed* managed* stored* archi&ed. +o# their
re&isions are managed
%escribe also the appro&al cycle
@ach pro2ect technical or management document is &eri)ed:
Technical #ise* by a member of the team*
Hy the ?uality manager
; member of the team appro&es each document.
'ro2ect meeting reports are &eri)ed by the attendants of the meetings.
2.112eri0cation
%escribe ho# &eri)cation is done and managed. 3e&ie#s* documentation E $ee
also chapter -
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/ Speci6cations
This chapter is an eAtract of the $oft#are 3e?uirements $peci)cations template.
+a&e a loo" at the $3$ template to see some eAamples of re?uirements.
3.1 States
C!! soft#are #or"s in three states:
$tarting: the soft#are loads its componentsI
1n use: all the functionalities of the soft#are are a&ailable to the usersI
$topping: the soft#are is being stopped.
Maintenance: the soft#are is in maintenance mode
;nd so on E
;dd a diagram #ith states and transitions if necessary
3.2 'erformance
This is the core of your $3$. 1t contains the purpose of your soft#are eApressed in
technical re?uirements
Fhat are its functions
Fhat are the algorithms used
E
3.3 Safety3 security3 and privacy protection
This section is about soft#are features li"e con)dentiality* integrity control*
reliability* and a&ailability. $ee Cyber$ecurity re?uirements of C%; and +1';;
re?uirements if necessary
3.4 %ser maintenance
Maintenance functions 9logs* archi&es* E:
3.5 %sability and #uman$factors en(ineerin(
The re?uirements here may ha&e traceability #ith result of 62566 standard
implementation
/0;01 (an machine interface la"o#t
The layout of 888 is E.
1nstead of a do7en of teAt re?uirements* a moc"-up of the soft#are JG1 is &ery
appreciated
;dd only re?uirements for #hich a description of layout/beha&iour is necessary
and/or re?uested by a user.
/0;07 Belp
The user guide is al#ays &ery important for medical de&ices. 1t may be online* in
this case add re?uirements here about the online help E.
;n about #indo# is a good #ay to identify soft#are &ersionE.
3.+ System environment
1f soft#are is integrated in a speci)c system* describe brieKy the system and add
speci)c re?uirements to #hich your soft#are shall comply
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3.- *4ternal interfaces
This section describes hard#are and soft#are interfaces of the soft#are in the
system
/0<01 Bardware interfaces
Cor '@M$/@lectro-medical %e&ices* add re?uirements about integration of
soft#are and hard#are.
/0<07 .etwor interfaces
;lso add here communication and net#or"s stuL* li"e 1'* #ireless* Hluetooth E
/0<0/ Data eDchange
1f 888 soft#are is in interface #ith other soft#are* describe here the
re?uirements on data eAchanges.
3.. Resources
1n #hat en&ironment runs the soft#are
/0C01 Bardware reso#rces
+ard#are re?uirements
/0C07 Software reso#rces
!$* libraries* eAternal programs re?uirements
3./ 5nternal data
1f speci)c re?uirements for internal data* li"e databases* binary )les* Aml E
3.11Adaptation
1f speci)c re?uirements adaptability of con)guration of soft#are
3.112eri0cation
$pecial functions to test the soft#are* if necessary. Cor eAample a hidden function
to acti&ate a log )le during beta tests
3.12'ersonnel and trainin(
3e?uirements about the capabilities/"no#ledge of users* the training the shall
ha&e before using soft#are
3.13'ac&a(in( and installation
3e?uirements about pac"aging* install shield E
Doc # Version: 01 Page > / 14
4 $rchitect#re = ,onception
4.1 Arc#itecture
Mot mandatory for class ;
40101 $rchitect#re overview
Ji&e a general description of the system* from the point of &ie# of the user :
1n #hat en&ironment it #or"s 9home* near patient bed* operating room E:
Fho the users are
Fhat it is for*
The main functions*
The main interfaces* inputs and outputs.
40107 2ogical architect#re overview
%escribe the top le&el soft#are components and their interactions/relationships.
Gse GML pac"age diagrams and/or layer diagrams and/or interface diagrams.
%escribe also the operating systems on #hich the soft#are runs.
4010/ Ph"sical architect#re overview
%escribe the hard#are components on #hich soft#are runs and their
interactions/relationships
Gse components diagrams* deployment diagrams* net#or" diagrams* interface
diagrams
4.2 onception
;bsolutely not mandatory for class ;.
Hut* if you #ant to do a better 2ob:
1f there are some parts that deser&e a more detailed conception* describe it here.
@g: a speci)c algorithm* memory cache management* details about the use of a
frame#or"* of a library* of a communication protocol* of a database modelE
; Veri6cation
This chapter is mandator"0
3arning this doc#ment maes the ass#mption that there is onl" one
test phase
5.1 !est 'lan
;0101 Test environment
This section describes the en&ironment of tests* from the point of &ie# of your
organi7ation and logistics.
%escribe #here is located the test platform.
%escribe the hard#are used to test your soft#are
1dentify accurately the soft#are used for test :
!$Ns and ser&ice pac"s
!$ dri&ers 9if speci)c for you:
Hac"up / reco&ery tools
Feb* blogs* CM$* %atabases engines*
Memory* dis" usage* C'G* and net#or" analysers*
Test co&erage or test management tools
$imulator* data generator of soft#are or hard#are that you don/t ha&e
;ny tiny 9or big: soft#are made by you to do the tests
Cor simple pro2ects* most of these may be tools pro&ided #ith the !$ 9df* du* ps*
top* dmesg* tas"manager* control panel E:* or consumer products 9M$ !Oce*
open oOce E:.
%escribe the sets of data used during tests. Their identi)cation* structure*
content* location* storage* 9structure and content may already be described in
the conception documents:*
input )les*
data )les*
scripts to generate data*
!utput )les* log )les
%escribe #hich documentation is deli&ered for the tests 9eg this document*
1nstructions Cor Gse E:* if it is printed or online.
1f speci)c hard#are is re?uired : paper in eAotic format* a stop#atch* a ruler* a
compass* a #illy #aller 2006
;nd also pi77as* bier* red bull* champagne E
;0107 ,#stomer/ 1ield test site
1f your product is tested in a health care centre* or if your customer is a medical
de&ice manufacturer* ha&e in mind that you may pro&ide your customer #ith
hard#are* soft#are* data and documentation. (ou may install it and maintain it.
+is opening hours may be constrained* his personnel shall ha&e speci)c
?uali)cations E
1f you #or" directly #ith praticians 9of your medical ad&isory board* for eAample:*
#ho are going to test your product in their oOces* describe ho# tests
input/output data are managed* ho# tests logs and bugs reports are collected.
5.2 !ests Description
;0701 Test identi6cation and content
@ach test is uni?ue and contains:
; uni?ue identi)er*
; teAtual description of test ob2ecti&e*
The traceability of the re?uirement9s: in P5*
The &eri)cation method 91* ;* %* T:*
%ata recording* post-processing and analysis procedure*
;ssumptions and constraints* if any
$afety* security and pri&acy concerns* if any.
The identi)er has the follo#ing structure:
%e)ne your o#n uni?ue identi)ers.
Cor eAample* concat the chars QT-Q* the P5 re?uirement 1% being tested*
Q-R* and an incremental number 9if more than 1 test is need to &erify the
re?uirement:.
;0707 Tests description
The traceability bet#een tests and re?uirements in P5 and tests belo# is listed in
the P, 3e?uirements traceability.
; re?uirement may re?uire more than one test to be &eri)ed. 1n this case* it
appears in all tests* #hich &erify it.
%escribe each test #ith the pattern belo#.
Cor most of tests* only a subset of )elds in the table is used* mar" M/; 9non
applicable: the unused )elds.
Test %D T!)9E!001
Test
description
$mall description
Beri)ed
3e?uirement
$3$-3@D-001 Beri)cation method: 1*;*%*T
1nitial
conditions
The state of soft#are before
test
(ou may reference a procedure
or it may be the result of
pre&ious test
Tests inputs 1nput data from any test tool*
input )les name and location
to use the test tool
%ata
collection
actions
3ecording and post processing
of output data
to record data #ith a test tool
Tests outputs !utput data )les names and
location* logs E
Ji&e uni?ue name out output
data )les.
;ssumptions
and
constraints
1f any* may be limited access
to a tool* license E
@Apected
results and
criteria
List here the results of test ;nd the criteria to e&aluate the
result
Test
proced#re
Step
n#m-er
&perator actions 9Dpected res#lt and
eval#ation criteria
1 $tart foo Coo is started
Doc # Version: 01 Page 1/ / 14
? Tests )es#lts
+.1 Rationale for decision
;fter eAecuting a test* the decision is de)ned according to the follo#ing rules:
&F: The test sheet is set to S!TS state #hen all steps are in S!TS state.
The real result is compliant to the eApected result.
.&F: The test sheet is set to SM!TS state #hen all steps of the test are set
to SM!TS state or #hen the result of a step diLers from the eApected result.
.&T )G.: %efault state of a test sheet not yet eAecuted.
.&T ,&(P29T9D: The test sheet is set to SMot CompletedS state #hen at
least one step of the test is set SMot 3unS state.
+.2 Results
Ji&e a fe# information about tests.
The 888 soft#are 9&ersion A.y.7: #as tested on the AAA test platform located in
AAA* from the yyyy/mm/dd to the yyyy/mm/dd. The tests of the test phase 9ref.
soft#are test plan: #here eAecuted.
Testers #here: Uohn %oe* Marc $mith
3epeat the list of tests* #ith one more column named QresultR.
1n result* add !T or M!T or Mot 3un. 1f M!T* add a bug id.
Test %D T!)9E!001 &V9)$22 )9SG2T &F
Test
description
$mall description
Beri)ed
3e?uirement
$3$-3@D-001 Beri)cation method: 1*;*%*T
1nitial
conditions
The state of soft#are
before test
or it may be the result of
pre&ious test
Tests inputs 1nput data from any
test tool* input )les
name and location
to use the test tool
%ata
collection
actions
3ecording and post
processing of output
data
to record data #ith a test tool
Tests
outputs
!utput data )les
names and location*
logs E
Ji&e uni?ue name out output
data )les.
;ssumptions
and
constraints
1f any* may be limited
access to a tool*
license E
@Apected
results and
criteria
List here the results
of test
;nd the criteria to e&aluate the
result
Test
proced#re
Step
n#m-er
&perator actions 9Dpected res#lt and
eval#ation criteria
)es#lt
1 $tart foo Coo is started !T
< )e@#irements tracea-ilit"
This table gi&es the traceability bet#een re?uirements and tests* and the method
of test.
The &eri)cation methods of the re?uirements are de)ned belo#:
1nspection 91:: control or &isual &eri)cation
;nalysis 9;:: &eri)cation based upon analytical e&idences
%emonstration 9%:: &eri)cation of operational characteristics* #ithout
?uantitati&e measurement
Test 9T:: &eri)cation of ?uantitati&e characteristics #ith ?uantitati&e
measurement
Cor each re?uirement of the $3$* a &eri)cation method is de)ned. Method is
abbre&iated 1* ;* % or T.
Cor each re?uirement* there shall be at least one test.
)e@0 %D )e@0 la-el Test %D Test desc0 (et
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