ࡱ>  ;bjbj 3G-, 8LCzF : F$. t/42ED4$@F$D4H4(6 p(6(6(6L4R  (6D4(6(6b68".@n~j5nVJ0Cćj۔(6۔.(6.D4D4D4 R:    TABLE OF CONTENTS  TOC \o "1-3" 1 INTRODUCTION  PAGEREF _Toc189651973 \h 2 1.1 Document overview  PAGEREF _Toc189651974 \h 2 1.2 Abbreviations and Glossary  PAGEREF _Toc189651975 \h 2 1.2.1 Abbreviations  PAGEREF _Toc189651976 \h 2 1.2.2 Glossary  PAGEREF _Toc189651977 \h 2 1.3 References  PAGEREF _Toc189651978 \h 2 1.3.1 Project References  PAGEREF _Toc189651979 \h 2 1.3.2 Standard and regulatory References  PAGEREF _Toc189651980 \h 2 1.4 Conventions  PAGEREF _Toc189651981 \h 2 2 REQUIREMENTS  PAGEREF _Toc189651982 \h 4 2.1 States  PAGEREF _Toc189651983 \h 4 2.2 Performance  PAGEREF _Toc189651984 \h 4 2.3 Safety, security, and privacy protection  PAGEREF _Toc189651985 \h 4 2.4 User maintenance  PAGEREF _Toc189651986 \h 5 2.5 Usability and human-factors engineering  PAGEREF _Toc189651987 \h 5 2.5.1 Man machine interface layout  PAGEREF _Toc189651988 \h 5 2.5.2 Help  PAGEREF _Toc189651989 \h 5 2.6 System environment  PAGEREF _Toc189651990 \h 6 2.7 External interfaces  PAGEREF _Toc189651991 \h 6 2.7.1 Hardware interfaces  PAGEREF _Toc189651992 \h 6 2.7.2 Network interfaces  PAGEREF _Toc189651993 \h 6 2.7.3 Data exchange  PAGEREF _Toc189651994 \h 6 2.8 Resources  PAGEREF _Toc189651995 \h 6 2.8.1 Hardware resources  PAGEREF _Toc189651996 \h 6 2.8.2 Software resources  PAGEREF _Toc189651997 \h 6 2.9 Internal data  PAGEREF _Toc189651998 \h 6 2.10 Adaptation  PAGEREF _Toc189651999 \h 7 2.11 Verification  PAGEREF _Toc189652000 \h 7 2.12 Personnel and training  PAGEREF _Toc189652001 \h 7 2.13 Packaging and installation  PAGEREF _Toc189652002 \h 7 3 VERIFICATION METHODS  PAGEREF _Toc189652003 \h 8 4 REQUIREMENTS TRACEABILITY  PAGEREF _Toc189652004 \h 10 5 CRITICAL REQUIREMENTS  PAGEREF _Toc189652005 \h 11  INTRODUCTION Document overview This document presents the software requirements specifications of XXX software development project. It describes: Requirements of functionalities, performances, interfaces, environment Tests principles and definitions of validation methods of requirements, The compliance of requirements to customer needs, The relative importance and precedence of requirements Abbreviations and Glossary Abbreviations Add here abbreviations Glossary Add here words definitions References Project References #Document IdentifierDocument Title[R1]IDAdd your documents references. One line per document Standard and regulatory References #Document IdentifierDocument Title[STD1]Add your documents references. One line per document Conventions Requirements listed in this document are constructed according to the following structure: Requirement Id Requirement title Requirement description Requirement version Example: SRS-XXX-000 Title of XXX-000 requirement Description of XXX-000 requirement Version of XXX-000 REQUIREMENTS Note: have a look at  HYPERLINK "http://en.wikipedia.org/wiki/Requirement" http://en.wikipedia.org/wiki/Requirement, article in wikipedia. Its well written and the links at the bottom are useful. States FOO software works in three states: Starting: the software loads its components; In use: all the functionalities of the software are available to the users; Stopping: the software is being stopped. Maintenance: the software is in maintenance mode And so on Add a diagram with states and transitions if necessary Performance This is the core of your SRS. It contains the purpose of your software expressed in technical requirements SRS-XXX-010 SAMPLE Sample requirement about a function FOO software shall compute the zzz parameters with the a, , c and d input parameter, with the use of the XXX algorithm. V1.0 SRS-XXX-020 SAMPLE Sample requirement about a function FOO software shall save the result of computations in boo-bar format. V1.0 Safety, security, and privacy protection This section is about software features like confidentiality, integrity control, reliability, and availability. See CyberSecurity requirements of FDA and HIPAA requirements if necessary SRS-XXX-030 SAMPLE Patient data XXX ensures that the displayed patient data are the same as read in the input files. The patients data are: Name, Date of birth, V1.0 User maintenance SRS-XXX-040 SAMPLE Application logs XXX generates a log file containing: The state of the application and the steps performed to reach that state, The possible error logs, if any. V1.0 Usability and human-factors engineering The requirements here may have traceability with result of 62366 standard implementation Man machine interface layout The layout of XXX is . Instead of a dozen of text requirements, a mock-up of the software GUI is very appreciated Add only requirements for which a description of layout/behaviour is necessary and/or requested by a user. SRS-XXX-050 SAMPLE Menu items and other widgets XXX software has the following items: Menu file ... Widgets in the main window (slider, button, radiobutton, textfield). V1.0 Help The user guide is always very important for medical devices. It may be online, in this case add requirements here about the online help . SRS-XXX-060 SAMPLE Online user guide XXX contains an online user guide V1.0 An about window is a good way to identify software version. SRS-XXX-070 SAMPLE About XXX XXX shall display an About window. This window displays the current version of the application. V1.0 System environment If software is integrated in a specific system, describe briefly the system and add specific requirements to which your software shall comply Warning: for PEMS/Electro-medical Devices with a big system architecture, a system architecture document is necessary to describe the system/software architecture. External interfaces This section describes hardware and software interfaces of the software in the system Hardware interfaces For PEMS/Electro-medical Devices, add requirements about integration of software and hardware. Network interfaces Also add here communication and networks stuff, like IP, wireless, Bluetooth Data exchange If XXX software is in interface with other software, describe here the requirements on data exchanges. Resources Hardware resources SRS-XXX-080 SAMPLE Hardware configuration XXX shall run with the expected response times on a PC with the following minimal configuration: 2 Go RAM ... V1.0 Software resources SRS-XXX-090 SAMPLE Software configuration XXX runs in the following software environment: (describe OS version), V1.0 Internal data If specific requirements for internal data, like databases, binary files, xml Adaptation If specific requirements adaptability of configuration of software Verification Special functions to test the software, if necessary. For example a hidden function to activate a log file during beta tests Personnel and training Requirements about the capabilities/knowledge of users, the training the shall have before using software SRS-XXX-USR-010 SAMPLE E-learning XXX is delivered with e-learning module. V1.0 Packaging and installation SRS-XXX-PAK-010 SAMPLE Packaging XXX shall be delivered on zzz media. V1.0 SRS-XXX-PAK-010 SAMPLE Install-shield XXX shall be installed with the use of an install shield. V1.0 VERIFICATION METHODS The verification methods of the requirements are defined below: Inspection (I): control or visual verification Control of the physical implementation or the installation of a component. The control verifies that the implementation or the installation of a component is compliant with the requirements of diagrams. Control of the documentation describing a component. The control verifies that the documentation is compliant with the requirements. Analysis (A): verification based upon analytical evidences Verification of a functionality, performance or technical solution of a component by analyzing the data collected by tests in real conditions, by simulation of real conditions or by a analysis report. Analysis of test data or of design data is used as appropriate to verify requirements. The verification is based upon analytical evidences obtained by calculations, like modeling, simulation and forecasting. Analysis is used when an acceptable level of confidence cannot be established by other methods or if analysis is the most cost-effective solution. Demonstration (D): verification of operational characteristics, without quantitative measurement Verifying a requirement by demonstration implies that the required functionality specified by a requirement is complete. Demonstration is used when quantitative measurement is not required for verification of the requirements Demonstration includes the control of the technical solutions specified by the non-functional requirements. Test (T): verification of quantitative characteristics with quantitative measurement Verifying a functionality, performance or technical solution of a component by executing testing scenarios in predefined, controlled and traceable testing conditions. Tests require the use of special equipment, instrumentation, simulation techniques, or the application of established principles and procedures, Data produced during tests is used to evaluate quantitative results and compare them with requirements. For each requirement of the SRS, a verification method is defined. Method is abbreviated I, A, D or T. Requirement IDRequirement TitleMethodREQ-001Verify that the speed is displayed in rpmDREQ-001Verify that the color of background is blueI Note: do not mistake the two meanings of the word test in this document: The method of verification, named Test and abbreviated (T), as defined above. A test, or test case, is a sequence of actions to verify a requirement. Tests are defined in the software test plan. Examples of tests methods: Inspection: Verify that the color of background is blue, Verify that the user manual has the CE mark on its cover Verify that the PC has 4Gb memory Verify that firmware version on electronic card is 1.0.1 Demonstration Verify that when the user closes the window, a confirmation message appears Verify that the file is saved in the output directory Verify that the result is shown Verify that if a value is out of range, a warning is displayed Analysis: Verify that the statistical distribution of results of xxx algorithm is a Gaussian with mean=x and stdev=y, when input data are blah blah Verify that the linear regression of results of xxx algorithm is a line which value is 1 on the y-axis, at zero on the x-axis, Test: Verify that a file of 1Gb is processed in less than 3s Verify that the response time of the server is 15ms with 20 simultaneous requests Rule of thumb for software, 80% of requirements are verified by demonstration, 15% by inspection and 5% by analysis or test methods. REQUIREMENTS TRACEABILITY Add a table with traceability of technical requirements of this document with functional requirements. Example SRS Req.Req TitleFunctional Req.Req. TitleSRS-REQ-001Reading ECG valuesFUN-REQ-00AECG post treatmentSRS-REQ-002Writing resultsFUN-REQ-00AECG post treatment CRITICAL REQUIREMENTS If necessary, add a list of critical requirements, or a list of reference to requirements in previous sections. This list may be the result of risk analysis (ISO 14971). Examples Requirement IDRequirement TitleOriginREQ-001Alarm when value out of rangeRisk AnalysisREQ-002Do not open file if no patient nameRisk AnalysisREQ-003Display negative values in red colorHuman factor engineering     Software Requirements Specifications of XXX softwareDoc #Version: 01Page  PAGE 1 /  NUMPAGES 1 This Template is the property of Cyrille Michaud License terms: see  HYPERLINK "http://blog.cm-dm.com/post/2011/11/04/License" http://blog.cm-dm.com/post/2011/11/04/License More templates to download on the:  HYPERLINK "http://blog.cm-dm.com/pages/Software-Development-Process-templates" Templates Repository for Software Development Process (click here) Or paste the link below in your browser address bar: http://blog.cm-dm.com/pages/Software-Development-Process-templates This work is licensed under the: Creative Commons Attribution-NonCommercial-NoDerivs 3.0 France License: http://creativecommons.org/licenses/by-nc-nd/3.0/fr/ Waiver: You can freely download and fill the templates of blog.cm-dm.com, to produce technical documentation. 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