EPLC_System_Req_Spec_v2.1.doc

SUBJECT \* MERGEFORMAT Requirements Definition

Version: 1.0 Error! Unknown document property name.

Food and Drug Administration

<Project Name & Release Version #> Enterprise Performance LifeCycle

SYSTEM REQUIREMENTS SPECIFICATION

Document Version Number: <<#.#> Document Version Date: <mm/dd/yyyy> Notes to the Author

[This document is a template of a System Requirements Specification document for a project. The template includes instructions to the author, boilerplate text, and fields that should be replaced with the values specific to the project.

· Blue italicized text enclosed in square brackets ([text]) provides instructions to the document author, or describes the intent, assumptions and context for content included in this document.

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· Text and tables in black are provided as boilerplate examples of wording and formats that may be used or modified as appropriate to a specific project. These are offered only as suggestions to assist in developing project documents; they are not mandatory formats.

When using this template, the following steps are recommended:

1. Replace all text enclosed in angle brackets (e.g., <Project Name>) with the correct field document values. These angle brackets appear in both the body of the document and in headers and footers. To customize fields in Microsoft Word (which display a gray background when selected) select File->Properties->Summary and fill in the appropriate fields within the Summary and Custom tabs.

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These actions must be done separately for any fields contained with the document’s Header and Footer.

2. Modify boilerplate text as appropriate for the specific project.

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5. Before submission of the first draft of this document, delete this instruction section “Notes to the Author” and all instructions to the author throughout the entire document.

VERSION HISTORY

[Provide information on how the development and distribution of the System Requirements Specification will be controlled and tracked. Use the table below to provide the version number, the author implementing the version, the date of the version, the name of the person approving the version, the date that particular version was approved, and a brief description of the reason for creating the revised version.] Version Number Implemented

By Revision

Date Approved

By Approval

Date Description of Change

Table of Contents 61.0 Introduction

61.1

PURPOSE

62.0 Business Requirements Overview

62.1

ASSUMPTIONS / CONSTRAINTS

62.2

STAKEHOLDERS AND USERS

62.3

SYSTEM SCOPE

63.0

FUNCTIONAL REQUIREMENTS

73.1

FUNCTIONAL REQUIREMENTS GROUP 1

73.2

BUSINESS RULES

73.3

SYSTEM MESSAGES

74.0 Non-Functional Requirements

74.1

DESIGN CONSTRAINTS

74.2

HARDWARE REQUIREMENTS

74.3

SOFTWARE REQUIREMENTS

84.4

PERFORMANCE REQUIREMENTS

84.5

CAPACITY REQUIREMENTS

84.6

RELIABILITY REQUIREMENTS

94.7

SUPPORTABILITY REQUIREMENTS

94.8

USER DOCUMENTATION REQUIREMENTS

94.9

RECORDS MANAGEMENT REQUIREMENTS

94.10

INTERFACE STANDARDS

104.11

SECURITY AND PRIVACY REQUIREMENTS

104.12

COMPLIANCE AND STANDARDS REQUIREMENTS

154.13

LICENSING REQUIREMENTS

154.14

LEGAL, COPYRIGHT, AND OTHER NOTICES

154.15 Applicable Data-exchange and Terminology Standards

155.0 Business Process Model

156.0 Logical Data Model

167.0 Requirements Traceability Matrix

17APPENDIX A: SYSTEM REQUIREMENTS SPECIFICATION APPROVAL

18APPENDIX B: REFERENCES

19APPENDIX C: KEY TERMS

20APPENDIX D: Business Process Model

21APPENDIX E: Logical Data Model

1.0 Introduction

1.1 PURPOSE

[Provide the purpose of the Functional System Requirements Specification Document. This document should be tailored to fit a particular project’s needs.]

[The System Requirements Specification defines the functional, non-functional, and technical requirements. The System Requirements Specification document is created during the Requirements Analysis Phase of the project. Its intended audience is the project manager, project team, project sponsor, client/user, and any stakeholder whose input/approval into the System Requirements Specification process is needed.]

2.0 Business Requirements Overview

[Describe here the business requirements that the project work will fulfill and how and/or where the completed project product will fit into any existing systems. Business requirements can often be described as “features.” Assign a unique ID number to each requirement.]

2.1 ASSUMPTIONS / CONSTRAINTS

[Describe any overall assumptions / constraints related to project requirements]

2.2 STAKEHOLDERS AND USERS

[Describe the stakeholders, users, and list all stakeholders’ needs. Include a context diagram if appropriate. ]

2.3 SYSTEM SCOPE

[Describe the features and interfaced systems. Include a context diagram if appropriate.]

3.0 FUNCTIONAL REQUIREMENTS

[Functional requirements capture and specify intended behavior of the system being developed. They define things such as system calculations, data manipulation and processing, user interface and interaction with the application, and other specific functionality that show how user requirements are satisfied. Assign a unique ID number to each requirement.

The functional requirements are grouped according to the project’s needs, and maybe influenced by the requirements tools and techniques used. ]

3.1 FUNCTIONAL REQUIREMENTS GROUP 1

[Functional Requirements 1]

3.2 BUSINESS RULES

[Describe the business rules as applied to this application.]

3.3 SYSTEM MESSAGES

[Describe system messages (status and error messages, acknowledgements, departure messages, etc.).]

4.0 Non-Functional Requirements

[Describe the existing non-functional (also referred to as Quality of Service by the International Institute of Business Analysts, Business Analysis Body of Knowledge), technical environment, systems, functions, and processes. Include an overview of the non-functional requirements necessary to achieve the project’s objectives.]

4.1 DESIGN CONSTRAINTS

[Describe hardware/software requirements that will limit the design or COTS options. These may include laws, regulations, hardware limitations, interfaces, development environment, operational environment, criticality, safety, and/or security. Assign a unique ID number to each requirement.]

4.2 HARDWARE REQUIREMENTS

[Describe hardware requirements and any related processes. Include a detailed description of specific hardware requirements and associate them to specific project functionality/deliverables. Include information such as type of hardware, brand name, specifications, size, security, etc. Assign a unique ID number to each requirement.]

4.3 SOFTWARE REQUIREMENTS

[Describe software requirements and any related processes. Include a detailed description of specific software requirements and associate them to specific project functionality/deliverables. Include information such as in-house development or purchasing, security, coding language, version numbering, functionality, data, interface requirements, brand name, specifications, etc. Assign a unique ID number to each requirement.]

4.4 PERFORMANCE REQUIREMENTS

[Describe performance requirements and any related processes. Include a detailed description of specific performance requirements and associate them to specific project functionality/deliverables. Where available include specific response times. Some topics to cover regarding performance requirements may include:

· Response time for a transaction (average, maximum)

· Transactions to be processed within certain time periods

· Degradation modes (what is the acceptable mode of operation when the system has been degraded in some manner)

· Resource utilization, such as memory, disk, numbers of files and records to be handled, sizes of files and records, and maximum usage of resource capacity, communications.

Assign a unique ID number to each requirement.]

4.5 CAPACITY REQUIREMENTS

[Describe all of the technical requirements that affect capacity. Some examples are:

· Number of simultaneous users supported

· Throughput (transactions per second)

· Load-balancing requirements

· Capacity (the number of customers or transactions the system can accommodate) Assign a unique ID number to each requirement.]

4.6 RELIABILITY REQUIREMENTS

[Describe all of the technical requirements that affect availability such as hours of operation, level of availability required, down-time impact, support availability, accuracy, etc. Suggested reliability qualities may include:

· Availability - specifies the percentage of time available (xx.xx%), hours of use, maintenance access, degraded mode operations, and so on.

· Mean Time Between Failures (MTBF) – specify hours, days, months, or years.

· Mean Time To Repair (MTTR) - How long should the system allowed to be out of operation after it has failed?

· Accuracy - Specify precision (resolution) and accuracy (by some known standard) that is required in the system’s output.

· Maximum Bugs or Defect Rate - Express in terms of bugs per thousand lines of code (bugs/KLOC) or bugs per function-point (bugs/function-point).

· Bugs or Defect Rate - categorized in terms of minor, significant, and critical bugs: the requirement(s) must define what is meant by a “critical” bug; for example, complete loss of data or a complete inability to use certain parts of the system’s functionality.

Assign a unique ID number to each requirement.]

4.7 SUPPORTABILITY REQUIREMENTS

[Describe all of the technical requirements that affect supportability and maintainability such as coding standards, naming CONVENTIONS; maintenance access, required utilities, etc. Assign a unique ID number to each requirement.]

4.8 USER DOCUMENTATION REQUIREMENTS

[Describe the requirements, for any special or on-line user documentation or help systems, glossary, etc. Assign a unique ID number to each requirement.]

4.9 records management REQUIREMENTS

[Include the metadata for Final_Action/Close_Date. Specify Cutoff_Date, and Delete_Date/Transfer_Date in order to calculate the disposition date at a record level. When eligible for disposition, the data will either be deleted or transferred to the National Archives and Records Administration (NARA), depending on whether the records are temporary or permanent. The level of implementation (system level or higher level) will be determined by the IT and business owners]

4.10 INTERFACE STANDARDS

[Describe all of the interface requirements (such as user interface, technical (hardware and software interface) and communications interface requirements. Assign a unique ID number to each requirement.]

4.10.1 USER INTERFACE STANDARDS

[This subsection of the System Requirements Specification describes the user interfaces that will be implemented by the system. Describe screen location of navigation controls or command items, refer to keyboard accessibility, display of data, use of independent windows, etc.]

4.10.2 HARDWARE INTERFACE STANDARDS

[This subsection of the System Requirements Specification defines the hardware interfaces that will be supported by the software, including logical structure, physical addresses, expected behavior, etc.]

4.10.3 SOFTWARE INTERFACE STANDARDS

[This subsection of the System Requirements Specification describes the software interfaces between the items identified in this document to other components of the system. These may be purchased components, components reused from another application or components being developed for subsystems outside of the scope of this document.]

4.10.4 COMMUNICATIONS INTERFACE

[This subsection of the System Requirements Specification describes any system communications interfaces with other systems or devices such as local area networks, remote serial devices, etc.]

4.11 SECURITY AND PRIVACY REQUIREMENTS

[Summarize and refer to the Privacy Impact Assessment produced during Planning phase and its impact on security requirements. Provide justifications for why a specific privacy item is needed. Provide Security Categorization if available.

Describe all of the technical requirements that affect security such as security audits, cryptography, user data, system identification/authentication, resource utilization, facility access times, etc.

Identify the security environment within which the software must operate and the level of security to be provided in accordance with NIST SP 800-53. Reference the Security Risk Assessment Report and the safeguards required to minimize those risks. The results of the NIST SP 800-53 analysis will describe the security steps that must be taken to assure the system is adequately protected. Include any privacy considerations that must be provided in accordance with the Privacy Provisions of the e-Government Act of 2002.

Assign a unique ID number to each requirement. ]

4.12 COMPLIANCE AND STANDARDS REQUIREMENTS

[Describe the existing compliance environment as it affects project requirements, and the standards the system development must follow. Include an overview of the compliance or standards requirements necessary to achieve the project’s objectives. List all that are applicable to the project. Assign a unique ID number to each requirement.]

4.12.1 SECTION 508 COMPLIANCE

[This section applies to the systems that are required to be Section 508 compliant.

The "Accessibility" page of the FDA Intranet site can be found at: http://www.fda.gov/AboutFDA/AboutThisWebsite/Accessibility/default.htm The following requirements come directly from the 508 PAR: Product Accessibility Review document. Select the requirements that best fit project.

Describe if and how the Section 508 of the Rehabilitation Act affects the system; cite the technical standards it must meet.]

4.12.1.1 Software Applications and Operating Systems

(a) When software is designed to run on a system that has a keyboard, product functions shall be executable from a keyboard where the function itself or the result of performing a function can be discerned textually.

(b) Applications shall not disrupt or disable activated features of other products that are identified as accessibility features, where those features are developed and documented according to industry standards. Applications also shall not disrupt or disable activated features of any operating system that are identified as accessibility features where the application programming interface for those accessibility features has been documented by the manufacturer of the operating system and is available to the product developer.

(c) A well-defined onscreen indication of the current focus shall be provided that moves among interactive interface elements as the input focus changes. The focus shall be programmatically exposed so that Assistive Technology can track focus and focus changes.

(d) Sufficient information about a user interface element including the identity, operation, and state of the element shall be available to Assistive Technology. When an image represents a program element, the information conveyed by the image must also be available in text.

(e) When bitmap images are used to identify controls, status indicators, or other programmatic elements, the meaning assigned to those images shall be consistent throughout an application’s performance.

(f) Textual information shall be provided through operating system functions for displaying text. The minimum information that shall be made available is text content, text input caret location, and text attributes.

(g) Applications shall not override user-selected contrast and color selections and other individual display attributes.

(h) When animation is displayed, the information shall be displayable in at least one non-animated presentation mode at the option of the user.

(i) Color coding shall not be used as the only means of conveying information, indicating an action, prompting a response, or distinguishing a visual element.

(j) When a product permits a user to adjust color and contrast settings, a variety of color selections capable of producing a range of contrast levels shall be provided.

(k) Software shall not use flashing or blinking text, objects, or other elements having a flash or blink frequency greater than 2Hz and lower than 55Hz.

(l) When electronic forms are used, the form shall allow people using Assistive Technology to access the information, field elements, and functionality required for completion and submission of the form, including all directions and cues.

4.12.1.2 Web Based Internet Information and Applications

(a) A text equivalent for every non-text element shall be provided (e.g., via "alt", "longdesc", or in element content).

(b) Equivalent alternatives for any multimedia presentation shall be synchronized with the presentation.

(c) Web pages shall be designed so that all information conveyed with color is also available without color, for example from context or markup.

(d) Documents shall be organized so they are readable without requiring an associated style sheet.

(e) Redundant text links shall be provided for each active region of a server-side image map.

(f) Client-side image maps shall be provided instead of server-side image maps except where the regions cannot be defined with an available geometric shape.

(g) Row and column headers shall be identified for data tables.

(h) Markup shall be used to associate data cells and header cells for data tables that have two or more logical levels of row or column headers.

(i) Frames shall be titled with text that facilitates frame identification and navigation

(j) Pages shall be designed to avoid causing the screen to flicker with a frequency greater than 2 Hz and lower than 55 Hz.

(k) A text-only page, with equivalent information or functionality, shall be provided to make a web site comply with the provisions of this part, when compliance cannot be accomplished in any other way. The content of the text-only page shall be updated whenever the primary page changes.

(l) When pages utilize scripting languages to display content, or to create interface elements, the information provided by the script shall be identified with functional text that can be read by Assistive Technology.

(m) When a web page requires that an applet, plug-in or other application be present on the client system to interpret page content, the page must provide a link to a plug-in or applet that complies with 1194.21(a) through (l).

(n) When electronic forms are designed to be completed on-line, the form shall allow people using Assistive Technology to access the information, field elements, and functionality required for completion and submission of the form, including all directions and cues.

(o) A method shall be provided that permits users to skip repetitive navigation links.

(p) When a timed response is required, the user shall be alerted and given sufficient time to indicate more time is required

4.12.1.3 Video and Multi-media Products

(c) All training and informational video and multimedia productions which support the agency's mission, regardless of format, that contain speech or other audio information necessary for the comprehension of the content, shall be open or closed captioned.

(d) All training and informational video and multimedia productions which support the agency's mission, regardless of format, that contain visual information necessary for the comprehension of the content, shall be audio described.

e) Display or presentation of alternate text presentation or audio descriptions shall be user-selectable unless permanent.

4.12.1.4 Functional and Performance Criteria

(a) At least one mode of operation and information retrieval that does not require user vision shall be provided, or support for Assistive Technology used by people who are blind or visually impaired shall be provided.

(b) At least one mode of operation and information retrieval that does not require visual acuity greater than 20/70 shall be provided in audio and enlarged print output working together or independently, or support for Assistive Technology used by people who are visually impaired shall be provided.

(c) At least one mode of operation and information retrieval that does not require user hearing shall be provided, or support for Assistive Technology used by people who are deaf or hard of hearing shall be provided.

(d) Where audio information is important for the use of a product, at least one mode of operation and information retrieval shall be provided in an enhanced auditory fashion, or support for assistive hearing devices shall be provided.

(e) At least one mode of operation and information retrieval that does not require user speech shall be provided, or support for Assistive Technology used by people with disabilities shall be provided.

(f) At least one mode of operation and information retrieval that does not require fine motor control or simultaneous actions and that is operable with limited reach and strength shall be provided.

4.12.1.5 Information, Documentation, Support

(a) Product support documentation provided to end-users shall be made available in alternate formats upon request, at no additional charge.

(b) End-users shall have access to a description of the accessibility and compatibility features of products in alternate formats or alternate methods upon request, at no additional charge.

(c) Support services for products shall accommodate the communication needs of end-users with disabilities.

4.12.2 APPLICABLE INFORMATION EXCHANGES

[This section applies to the systems that are required to exchange data with other systems within the Federal Health Architecture and National Health Information Network. Describe if and how the Healthcare Information Technology Standards Panel and National eHealth Collaborative affects the system; cite the technical standards it must meet.]

4.12.3 INFORMATION STANDARDS AND TERMINOLOGIES

[This section applies to all systems that are required to be compliant with the Department of Health and Human Services’ adopted information standards and vocabularies. Describe applicability of information standards and vocabularies to data elements collected by the system and interchanged between internal and external information systems; cite the technical standards it must meet.]

4.13 LICENSING REQUIREMENTS

[Describe any licensing enforcement requirements or other usage restriction requirements that are to be used and / or enforced by the software, whether purchased or developed. List all that are applicable to the project.]

4.14 LEGAL, COPYRIGHT, AND OTHER NOTICES

[Describe any necessary legal disclaimers, warranties, copyright notices, patent notices, word mark, trademark, or logo compliance issues for the software, whether purchased or developed. List all that are applicable to the project.]

4.15 Applicable Data-exchange and Terminology Standards

[Describe any data-exchange or terminology standards to be utilized by this project. Pay particular attention to data-exchange and terminology standards already identified by the FDA Data Standards Council. For a readily available list of data-exchange and terminology standards, contact the OIM EA Team.]

5.0 Business Process Model

[Include the Business Process Model as an appendix.]

See Appendix D - <Project Name> Business Process Model.

6.0 Logical Data Model

[Include the Logical Data Model as an appendix.] See Appendix E - <Project Name> Logical Data Model.

7.0 Requirements Traceability Matrix

[In the Requirements Analysis phase, the matrix is populated with requirements identified in the System Requirements Specification. It is a living document that should be populated with information throughout design, construction, and test phases, etc. The Requirements Traceability Matrix should be attached as a separate document and referred to within this section. An EPLC Requirements Traceability Matrix Template is available in the EPLC eRoom.]

APPENDIX A: SYSTEM REQUIREMENTS SPECIFICATION APPROVAL

The undersigned acknowledge that they have reviewed the <Project Name> System Requirements Specification and agree with the information presented within this document. Changes to this System Requirements Specification will be coordinated with, and approved by, the undersigned, or their designated representatives.

Signature:

Date:

Print Name:

Title:

APPENDIX B: REFERENCES

[Insert the name, version number, description, and physical location of any documents referenced in this document. Add rows to the table as necessary.]

The following table summarizes the documents referenced in this document.

APPENDIX C: KEY TERMS

The following table provides definitions and explanations for terms and acronyms relevant to the content presented within this document.

APPENDIX D: Business Process Model

[Insert Business Process Model here.] APPENDIX E: Logical Data Model

[Insert Logical Data Model here.]

Template Version 2.1 (Last Modified on Oct, 29 2010)

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EPLC_System_Req_Spec_v#.#.doc