ࡱ> >@;<= Rbjbj yDDD+++++++++8+,|+.1:V1V1l1X5rDl6I8OQQQQQQZxQ+nK5@X5nKrKQN++V1l1fNNNvK+RV1+l1ONnKONN.Hb+"+/`O~+$MBK|0AtNt/N+/nKnKnKD ):    TABLE OF CONTENTS  TOC \o "1-2" 1 Introduction  PAGEREF _Toc203741747 \h 3 1.1 Document overview  PAGEREF _Toc203741748 \h 3 1.2 Scope  PAGEREF _Toc203741749 \h 3 1.3 Abbreviations and Glossary  PAGEREF _Toc203741750 \h 3 1.4 References  PAGEREF _Toc203741751 \h 3 1.5 Conventions  PAGEREF _Toc203741752 \h 3 2 Project Management  PAGEREF _Toc203741753 \h 5 2.1 Team human resources  PAGEREF _Toc203741754 \h 5 2.2 Responsibilities  PAGEREF _Toc203741755 \h 5 2.3 Customer -User involvement  PAGEREF _Toc203741756 \h 5 2.4 Tasks Planning - Milestones  PAGEREF _Toc203741757 \h 5 2.5 Engineering environment  PAGEREF _Toc203741758 \h 5 2.6 Other Resources  PAGEREF _Toc203741759 \h 5 2.7 Software life cycle model  PAGEREF _Toc203741760 \h 5 2.8 Reviews  PAGEREF _Toc203741761 \h 5 2.9 Software configuration management  PAGEREF _Toc203741762 \h 6 2.10 Documentation management  PAGEREF _Toc203741763 \h 6 2.11 Verification  PAGEREF _Toc203741764 \h 6 3 Specifications  PAGEREF _Toc203741765 \h 7 3.1 States  PAGEREF _Toc203741766 \h 7 3.2 Performance  PAGEREF _Toc203741767 \h 7 3.3 Safety, security, and privacy protection  PAGEREF _Toc203741768 \h 7 3.4 User maintenance  PAGEREF _Toc203741769 \h 7 3.5 Usability and human-factors engineering  PAGEREF _Toc203741770 \h 7 3.6 System environment  PAGEREF _Toc203741771 \h 7 3.7 External interfaces  PAGEREF _Toc203741772 \h 7 3.8 Resources  PAGEREF _Toc203741773 \h 8 3.9 Internal data  PAGEREF _Toc203741774 \h 8 3.10 Adaptation  PAGEREF _Toc203741775 \h 8 3.11 Verification  PAGEREF _Toc203741776 \h 8 3.12 Personnel and training  PAGEREF _Toc203741777 \h 8 3.13 Packaging and installation  PAGEREF _Toc203741778 \h 8 4 Architecture Conception  PAGEREF _Toc203741779 \h 9 4.1 Architecture  PAGEREF _Toc203741780 \h 9 4.2 Conception  PAGEREF _Toc203741781 \h 9 5 Verification  PAGEREF _Toc203741782 \h 10 5.1 Test Plan  PAGEREF _Toc203741783 \h 10 5.2 Tests Description  PAGEREF _Toc203741784 \h 10 6 Tests Results  PAGEREF _Toc203741785 \h 12 6.1 Rationale for decision  PAGEREF _Toc203741786 \h 12 6.2 Results  PAGEREF _Toc203741787 \h 12 7 Requirements traceability  PAGEREF _Toc203741788 \h 13  Introduction Summary: This is the all-in-one template for software development This template doesnt cover the risk management It is filled incrementally during the project. I suggest incrementing the version number when a chapter is full: Rev1: chapter 1 & 2 Rev2: chapter 3 & 4 Rev3: chapter 5 Rev4: chapter 6 Chapter 7 is filled in revision 1 and revision 2. Document overview This document contains the organization, the specifications, the conception, and verification tests of XXX software development project. It covers the following goals: XXX. Scope Identification This document applies to the XXX device(s) developed in the XXX project. Overview Project Overview 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 references 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 Typographical convention. Any other convention. Project Management For each of the sub-sections, if you already have a SOP in your QMS that covers the topic, add a reference to the SOP, and a little explanation if necessary. The section describes the organizational structure of the XXX project. Team human resources The team is described in the diagram below.  USERPROPERTY \* MERGEFORMAT Insert diagram of organization Responsibilities The team of the project has the following responsibilities: Technical Manager: XXX Project Manager: XXX XXX Customer -User involvement Describe how the end user is involved in the software development: meetings, reviews, and presentations of intermediate versions The customer may or may not be the end-user Tasks Planning - Milestones The planning below contains all tasks of the project and the links between tasks. Insert a table or list or diagram describing the planning. Engineering environment What kind of workstation / server do you use and every other hardware. Other Resources If specific resources are need for the project such as a calibrated measurement tool or a simulator, they shall be identified, referenced and managed in configuration. If not, add the following sentence There is no particular resource needed for the project such as a calibrated measurement tool or a simulator. Hence, no specific identification of resources is needed for the project, the hardware and software resources are interchangeable COTS. Software life cycle model Waterfall / RUP / Agile, quote your model Reviews The project begins with a launch review and ends with a final review. Two types or reviews occur during the project: Design Reviews Tests Reviews Launch Review is a formal, documented and systematic meeting during which the project team members get acquainted with the goals of the project and all other information contained in the management plan. Design Reviews are formal, documented and systematic meetings during which the current design of a product (system, sub system etc.) is reviewed and compared with the requirements. Design Reviews are scheduled in the project planning. The objective of Design Reviews is to critically appraise the design and development in accordance with the requirement, and to confirm and approve technical aspects. Test Reviews are formal, documented and systematic meetings during which the current design of a product is tested. Tests reviews are scheduled in the project planning. Final Review is a formal, documented and systematic meeting during which the President/Project manager/any other validates the XXX product (see validation process in software quality assurance plan ref. X). The review contains also a part devoted to the return on experience on progress of the project and on the processes used during the project. Software configuration management Describe configuration management: what tool do you use. What are the repositories (eg:work, integration, delivery, final). Documentation management Describe how documents are identified, managed, stored, archived. How their revisions are managed Describe also the approval cycle Each project technical or management document is verified: Technical wise, by a member of the team, By the quality manager A member of the team approves each document. Project meeting reports are verified by the attendants of the meetings. Verification Describe how verification is done and managed. Reviews, documentation See also chapter 5 Specifications This chapter is an extract of the Software Requirements Specifications template. Have a look at the SRS template to see some examples of requirements. 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 What are its functions What are the algorithms used 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 User maintenance Maintenance functions (logs, archives, ) 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. 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 . An about window is a good way to identify software version. System environment If software is integrated in a specific system, describe briefly the system and add specific requirements to which your software shall comply 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 In what environment runs the software Hardware resources Hardware requirements Software resources OS, libraries, external programs requirements 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 Packaging and installation Requirements about packaging, install shield Architecture Conception Architecture Not mandatory for class A Architecture overview Give a general description of the system, from the point of view of the user: In what environment it works (home, near patient bed, operating room ) Who the users are What it is for, The main functions, The main interfaces, inputs and outputs. Logical architecture overview Describe the top level software components and their interactions/relationships. Use UML package diagrams and/or layer diagrams and/or interface diagrams. Describe also the operating systems on which the software runs. Physical architecture overview Describe the hardware components on which software runs and their interactions/relationships Use components diagrams, deployment diagrams, network diagrams, interface diagrams Conception Absolutely not mandatory for class A. But, if you want to do a better job: If there are some parts that deserve a more detailed conception, describe it here. Eg: a specific algorithm, memory cache management, details about the use of a framework, of a library, of a communication protocol, of a database model Verification This chapter is mandatory. Warning this document makes the assumption that there is only one test phase Test Plan Test environment This section describes the environment of tests, from the point of view of your organization and logistics. Describe where is located the test platform. Describe the hardware used to test your software Identify accurately the software used for test: OSs and service packs OS drivers (if specific for you) Backup / recovery tools Web, blogs, CMS, Databases engines, Memory, disk usage, CPU, and network analysers, Test coverage or test management tools Simulator, data generator of software or hardware that you dont have Any tiny (or big) software made by you to do the tests For simple projects, most of these may be tools provided with the OS (df, du, ps, top, dmesg, taskmanager, control panel ), or consumer products (MS Office, open office ). Describe the sets of data used during tests. Their identification, structure, content, location, storage, (structure and content may already be described in the conception documents), input files, data files, scripts to generate data, Output files, log files Describe which documentation is delivered for the tests (eg this document, Instructions For Use ), if it is printed or online. If specific hardware is required: paper in exotic format, a stopwatch, a ruler, a compass, a willy waller 2006 And also pizzas, bier, red bull, champagne Customer/ Field test site If your product is tested in a health care centre, or if your customer is a medical device manufacturer, have in mind that you may provide your customer with hardware, software, data and documentation. You may install it and maintain it. His opening hours may be constrained, his personnel shall have specific qualifications If you work directly with praticians (of your medical advisory board, for example), who are going to test your product in their offices, describe how tests input/output data are managed, how tests logs and bugs reports are collected. Tests Description Test identification and content Each test is unique and contains: A unique identifier, A textual description of test objective, The traceability of the requirement(s) in 3, The verification method (I, A, D, T), Data recording, post-processing and analysis procedure, Assumptions and constraints, if any Safety, security and privacy concerns, if any. The identifier has the following structure: Define your own unique identifiers. For example, concat the chars T-, the 3 requirement ID being tested, -, and an incremental number (if more than 1 test is need to verify the requirement). Tests description The traceability between tests and requirements in 3 and tests below is listed in the 7 Requirements traceability. A requirement may require more than one test to be verified. In this case, it appears in all tests, which verify it. Describe each test with the pattern below. For most of tests, only a subset of fields in the table is used, mark N/A (non applicable) the unused fields. Test IDT-REQ-001Test descriptionSmall descriptionVerified RequirementSRS-REQ-001Verification method: I,A,D,TInitial conditionsThe state of software before testYou may reference a procedure or it may be the result of previous testTests inputsInput data from any test tool, input files name and locationYou may reference a procedure to use the test toolData collection actions Recording and post processing of output dataYou may reference a procedure to record data with a test toolTests outputsOutput data files names and location, logs Give unique name out output data files.Assumptions and constraintsIf any, may be limited access to a tool, license Expected results and criteriaList here the results of testAnd the criteria to evaluate the resultTest procedureStep numberOperator actionsExpected result and evaluation criteria1Start fooFoo is started Tests Results Rationale for decision After executing a test, the decision is defined according to the following rules: OK: The test sheet is set to "OK" state when all steps are in "OK" state. The real result is compliant to the expected result. NOK: The test sheet is set to "NOK" state when all steps of the test are set to "NOK" state or when the result of a step differs from the expected result. NOT RUN: Default state of a test sheet not yet executed. NOT COMPLETED: The test sheet is set to "Not Completed" state when at least one step of the test is set "Not Run" state. Results Give a few information about tests. The XXX software (version x.y.z) was tested on the xxx test platform located in xxx, from the yyyy/mm/dd to the yyyy/mm/dd. The tests of the test phase (ref. software test plan) where executed. Testers where: John Doe, Marc Smith Repeat the list of tests, with one more column named result. In result, add OK or NOK or Not Run. If NOK, add a bug id. Test IDT-REQ-001OVERALL RESULTOKTest descriptionSmall descriptionVerified RequirementSRS-REQ-001Verification method: I,A,D,TInitial conditionsThe state of software before testYou may reference a procedure or it may be the result of previous testTests inputsInput data from any test tool, input files name and locationYou may reference a procedure to use the test toolData collection actions Recording and post processing of output dataYou may reference a procedure to record data with a test toolTests outputsOutput data files names and location, logs Give unique name out output data files.Assumptions and constraintsIf any, may be limited access to a tool, license Expected results and criteriaList here the results of testAnd the criteria to evaluate the resultTest procedureStep numberOperator actionsExpected result and evaluation criteriaResult1Start fooFoo is startedOK Requirements traceability This table gives the traceability between requirements and tests, and the method of test. The verification methods of the requirements are defined below: Inspection (I): control or visual verification Analysis (A): verification based upon analytical evidences Demonstration (D): verification of operational characteristics, without quantitative measurement Test (T): verification of quantitative characteristics with quantitative measurement For each requirement of the SRS, a verification method is defined. Method is abbreviated I, A, D or T. For each requirement, there shall be at least one test. Req. IDReq. labelTest IDTest desc.Meth     Software development of XXXDoc #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 Thank-you for downloading the All In One Template! 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. The documents produced by filling the templates are outside the scope of the license. However, the modification of templates to produce new templates is in the scope of the license and is not allowed by this license. 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