ࡱ> CE@ABx~5@ bjbj22 nXXjx4 hX4 |h FfL($RgW WW WX  WH /(0??PH  ?H<xlڦrLh  z/X    EMBED PBrush  Company Name Here Cary, North Carolina  TITLE \* MERGEFORMAT User and Functional Requirements Specifications System Name:  DOCPROPERTY "Subject" \* MERGEFORMAT System Name and Version Number Prepared By: Name: Date:  DOCPROPERTY Author \* MERGEFORMAT Author, Title Department /// THIS PAGE MUST BE DELETED BEFORE PUBLICATION The purpose of this template is to assist in the interpretation, application, and preparation of the  TITLE \* MERGEFORMAT User and Functional Requirements Specifications according to Schering-Plough Research Institutes (SPRI) standard operating procedures relating to validating software applications. Paragraphs in blue italics font style are meant to serve as instructions to the Author and should be deleted in the final document. Paragraphs in black regular font style are sample wording that may be used as is or modified as needed. Should a paragraph not be applicable, delete it from the document altogether. Text in GRAY shading contains a field code, and will NOT automatically update. First, to assure that on your computer variable fields will display as gray in templates, select Tools from the menu and then Options from the drop down list. On the View tab, change the setting for Field Shading to display Always, by selecting it from the drop down list. Click OK. (Note: these gray fields will not be shaded when printing the document.) To change values associated with fields, select File from the menu and then Properties from the drop down list. Select the value in either the Summary tab or the Custom tab and change the value. For the Custom tab, then press the Modify button. To update the Table of Contents and all data displayed in field codes within the completed document, click on Edit / Select All from the menu and then press F9; select Update Entire Table and click OK. Text in should be replaced with the appropriate information by the Author. /// Approvals The individuals below agree that they have reviewed and approved the scope of the effort described in this  TITLE \* MERGEFORMAT User and Functional Requirements Specifications ( DOCPROPERTY "Title - Short" \* MERGEFORMAT URS-FRS) for  SUBJECT \* MERGEFORMAT System Name and Version Number, by signing this section. The  TITLE \* MERGEFORMAT User and Functional Requirements Specifications will be a living document and will serve as the primary means of communicating project change with regard to functionality. The signatures below represent the approval for the acceptance of the  TITLE \* MERGEFORMAT User and Functional Requirements Specifications ( DOCPROPERTY "Title - Short" \* MERGEFORMAT URS-FRS) and acceptance by PHARMASYS?? management representing both the user community and the implementation team. Approval Signatures APPROVED BY:FunctionNameSignatureDateTitle,  DOCPROPERTY Department \* MERGEFORMAT DepartmentNameCompliance/VQC/Validation Manager/LeaderNameTitle, System OwnerName Revision History Issue #DatePersonChange1.012/14/2006Nicholas RyanDocument Creation TABLE OF CONTENTS  TOC \o "2-3" \t "Heading 1,1" 1 Introduction  PAGEREF _Toc3787038 \h 7 1.1 Project Background  PAGEREF _Toc3787039 \h 7 1.2 Summary of the User and Functional Requirements Specifications  PAGEREF _Toc3787040 \h 7 1.2.1 Expected Benefits  PAGEREF _Toc3787041 \h 8 1.2.2 Consequences of Business Activities Failure  PAGEREF _Toc3787042 \h 8 1.2.3 Recommendations  PAGEREF _Toc3787043 \h 8 2 Purpose & Scope  PAGEREF _Toc3787044 \h 8 2.1 Goals & Objectives  PAGEREF _Toc3787045 \h 8 3 Assumptions, Exclusions and Limitations  PAGEREF _Toc3787046 \h 9 4 Abbreviations and Acronyms  PAGEREF _Toc3787047 \h 9 5 Reference Documents  PAGEREF _Toc3787048 \h 10 6 Requirements Specification  PAGEREF _Toc3787049 \h 11 6.1 Business Requirements  PAGEREF _Toc3787050 \h 11 6.1.1 Business Activities (Internal & External)  PAGEREF _Toc3787051 \h 11 6.1.2 Functional Description  PAGEREF _Toc3787052 \h 12 6.1.3 Outputs (Reports)  PAGEREF _Toc3787053 \h 12 6.1.4 Implementation Constraints  PAGEREF _Toc3787054 \h 12 6.2 Data Requirements  PAGEREF _Toc3787055 \h 13 6.2.1 Inputs  PAGEREF _Toc3787056 \h 13 6.2.2 Data Requirements (New or Existing System Integration)  PAGEREF _Toc3787057 \h 13 6.2.3 Data Migration  PAGEREF _Toc3787058 \h 14 6.3 Performance Requirements  PAGEREF _Toc3787059 \h 14 6.4 Environmental Requirements  PAGEREF _Toc3787060 \h 15 6.4.1 Facilities Requirements  PAGEREF _Toc3787061 \h 15 6.4.2 Technology Requirements  PAGEREF _Toc3787062 \h 15 6.4.3 System Topology  PAGEREF _Toc3787063 \h 16 6.4.4 Mechanical Requirements  PAGEREF _Toc3787064 \h 16 6.4.5 Special Equipment Requirements  PAGEREF _Toc3787065 \h 17 6.5 Security Requirements  PAGEREF _Toc3787066 \h 17 6.5.1 Passwords  PAGEREF _Toc3787067 \h 18 6.5.2 User ID / Authentication Controls  PAGEREF _Toc3787068 \h 19 6.5.3 Internal Software Controls  PAGEREF _Toc3787069 \h 20 6.5.4 Software COTS (Commercial Off the Shelf)  PAGEREF _Toc3787070 \h 21 6.5.5 Hardware  PAGEREF _Toc3787071 \h 21 6.5.6 Desktop / Laptop Dial-Up Controls  PAGEREF _Toc3787072 \h 22 6.5.7 Physical Security  PAGEREF _Toc3787073 \h 22 6.6 Audit Trail Requirements  PAGEREF _Toc3787074 \h 22 6.7 Documentation Requirements  PAGEREF _Toc3787075 \h 22 6.8 Maintenance Requirements  PAGEREF _Toc3787076 \h 23 6.9 Back-up, Restore and Archiving  PAGEREF _Toc3787077 \h 23 6.9.1 Archiving  PAGEREF _Toc3787078 \h 23 6.9.2 System Backup & Contingency  PAGEREF _Toc3787079 \h 23 6.9.3 Business Activities Interfaces  PAGEREF _Toc3787080 \h 24 6.10 Other Requirements  PAGEREF _Toc3787081 \h 25 7 Traceability Matrix  PAGEREF _Toc3787082 \h 25  Introduction The  TITLE \* MERGEFORMAT User and Functional Requirements Specifications ( DOCPROPERTY "Title - Short" \* MERGEFORMAT URS-FRS) documents the business and functional requirements of the  SUBJECT \* MERGEFORMAT System Name and Version Number system to be deployed. This is intended to be a living document. The requirements detailed in this  DOCPROPERTY "Title - Short" \* MERGEFORMAT URS-FRS document provide the definition of the  SUBJECT \* MERGEFORMAT System Name and Version Number from a user perspective: this includes the functional, security, data integrity, and performance capabilities that the  SUBJECT \* MERGEFORMAT System Name and Version Number must provide, in order to meet the business needs of users in the  DOCPROPERTY "Department" \* MERGEFORMAT Department ( DOCPROPERTY "Department - Short" \* MERGEFORMAT Dept.) department at Company Name Here. The  DOCPROPERTY "Title - Short" \* MERGEFORMAT URS-FRS will also provide additional information to expand the project plan for realistic tasks, dates and resources. Project Background /// Briefly describe the systems goals, objectives, and regulatory requirements. Mention if this system is an upgrade of a previous version or a new installation. What is the future status and effective date of the system / planned roll-out? Describe if it is a purchased product, what customization has been added on. Some of the words would be similar to those found in the beginning of the Validation Strategy Document (VSD). /// This  SUBJECT \* MERGEFORMAT System Name and Version Number is designed to /// qualify, quantify, collect, recordwhat data? /// The complete system includes <_______>. /// If applicable, include: /// The conceptual process flow of the system is found in section <_____> below. Summary of the User and Functional Requirements Specifications The purpose of this  DOCPROPERTY "Title - Short" \* MERGEFORMAT URS-FRS document is to define the requirements of the  SUBJECT \* MERGEFORMAT System Name and Version Number, the  DOCPROPERTY Division \* MERGEFORMAT Schering-Plough Research Institute and to be utilized by the department(s)/division(s) of <_________> at the following location(s): <_________>. /// Summarize the contents of the document and provide a very brief description of the systems subsystems, their operations, and interaction. Highlight any major discrepancy or specific focus that is specific to this system. /// Expected Benefits /// Discuss any relevant impact statements, management issues and considerations, the applicable business unit service levels for technical support, system uptime, etc. Provide all necessary information here that database personnel may require. /// Consequences of Business Activities Failure /// Discuss any business activity problems. Document potential risks. Discuss what would be the consequences to the business community or to the individual user, should the application fail in part or in its entirety (temporary glitch or catastrophic failure event). /// Recommendations /// Discuss any recommendations regarding the technology or applications to be used. Delete this section, if N/A. /// Purpose & Scope This section addresses the objectives of the  DOCPROPERTY "Title - Short" \* MERGEFORMAT URS-FRS and its structure. Included in this section are the scope of work, the users naming convention, applicable standards, and assumptions. Goals & Objectives The objectives of the  DOCPROPERTY "Title - Short" \* MERGEFORMAT URS-FRS are to collect and organize in writing a baseline of the user (business) and functional requirements of the system. All testing which follows will relate back to this  DOCPROPERTY "Title - Short" \* MERGEFORMAT URS-FRS to demonstrate that the completed design of the system does in fact consider and is proven to meet and satisfy all such requirements, as specified by the business user and the technical community that will be associated with it. Assumptions, Exclusions and Limitations /// Describe the specific assumptions, limitation and exclusions applicable to the validation of this system (for example, that all hardware and software was functioning correctly, that certain activities occurred prior to testing (e.g. levels of access were correctly set up, etc.)). List the software products, components, modules, interfaces, or functions that were excluded from testing (e.g. functions not utilized by the users, etc.) Provide rationale for each, as to why testing was not performed. /// Assumptions governing the  DOCPROPERTY "Title - Short" \* MERGEFORMAT URS-FRS of the  SUBJECT \* MERGEFORMAT System Name and Version Number system are as follows: /// Assumptions - Describe the specific assumptions that were applicable to the validation of this system. Some examples of assumptions are: Users targeted to create requirements have an appropriate level of computer and functional literacy /// Exclusions that apply to the  DOCPROPERTY "Title - Short" \* MERGEFORMAT URS-FRS of the  SUBJECT \* MERGEFORMAT System Name and Version Number system are as follows: /// Exclusions - List the software products, components, modules, interfaces, or functions that were excluded from testing conducted within the confines of this study. Provide rationale for each, as to why testing was not performed. An example of an exclusion is: Requirements designated for future releases are not included in this document. /// Limitations that apply to the  DOCPROPERTY "Title - Short" \* MERGEFORMAT URS-FRS of the  SUBJECT \* MERGEFORMAT System Name and Version Number system are as follows: /// Limitations - Describe any limitations, which were applicable (perhaps relating to the platform, versioning, etc.). Describe the risks that were inherent, if any. Describe the critical success factors relating to the application, as applicable. Some examples of limitations are: Any errors that require manual workarounds identified in previous testing. List any workarounds that are known and required at this stage. /// Abbreviations and Acronyms Refer to  DOCPROPERTY "Department - Short" \* MERGEFORMAT Dept. SOP ///600.011 - Glossary/// and Standard SPRI-05 - Validation of Computer Systems for standardized departmental terminology. Below is a list of terms and acronyms specific to this project. /// Add other terms, abbreviations, acronyms and definitions as applicable to specific document being prepared. Delete the table, if no terms are added. /// Term / AbbreviationAcronymDefinition A more comprehensive list of applicable abbreviations and acronyms can be found in the Validation Strategy Document (VSD). Reference Documents The current revisions of the documents listed below have been consulted in the preparation of this specification document or govern the content of this document. /// Do not repeat documents already identified in the VSD. If the VSD is not written yet, then you may reference them, such as: Internal SOPs which govern this  DOCPROPERTY "Title - Short" \* MERGEFORMAT URS-FRS or relate to the system List the applicable process flows/guidelines that relate to this system. IMPORTANT: Only reference those that reflect current business practice. Vendor-supplied documentation RFP Other /// /// For each listed reference, include the document number, full title, version/revision number, effective date, issuing department, and type of document: /// Document NumberDocument TitleIssue NumberEffective DateDocument TypeSPRI-05Validation of Computer SystemsApril 1, 2002SPRI, StandardCorporate PolicyPart 11Electronic Records; Electronic SignaturesAugust 27, 1997US CFR, Regulation Requirements Specification /// In this Requirements section, define the business needs of the typical user in a clear and precise way. Outline what major tasks the user expects the system to accomplish and any external interfaces that are required of the system. Describe what legacy system, if any, is being replaced and what method/phases would be required for phasing out the old, in the new. /// /// The detailed requirements are uniquely identified with a Requirement Number (Requirement # or Req. #, comprised of a sequential number prefaced by an alphanumeric identifier, which represents the Description Category of the applicable business requirement, as suggested in the table below.) NOTE: The numbering system is a suggestion and may be modified to suit the needs of the Author. An alternative method may be 4.4.7.1, 4.4.7.2, 4.4.7.3, etc. /// Requirement NumberDescription CategoryRS-1Enhanced Business ProcessesRS-2Systems InterfaceRS-3Data MigrationRS-4Systems IntegrationRS-5Data Management and AccessRS-6Code ManagementRS-7Compliance (Predicate Rules and Part 11 Compliance)RS-8Application Performance Business Requirements Business Activities (Internal & External) /// Briefly describe the daily activities of the business user. What is the role the user is expected to fill? Define logical business activities. As applicable, develop a process decomposition diagram. /// Requirement #DescriptionRS-BA-1RS-BA-2 Functional Description /// Describe the functional role/purpose of the system as part of the overall daily user activities. How does the system assist the user? Then provide a detailed description of the functional requirements of the system from a technical viewpoint. /// Requirement #DescriptionRS-FD-1RS-FD-2 Processing (Algorithms) /// Describe any critical, essential calculations, which the system uses to process its data. /// Outputs (Reports) /// List and describe all printout reports or export files generated by the  SUBJECT \* MERGEFORMAT System Name and Version Number. /// Requirement #DescriptionRS-OR-1RS-OR-1 Implementation Constraints /// Determine and discuss what system constraints would apply in implementation of the system: Time constraints, deadline for rollout. Cost constraints IT/technology constraints (equipment, support, software readiness, etc.) Resource constraints Any changes affecting the project scope, schedule, quality, or costs are subject to the change management process and formal approval. Constraints between existing systems. Number of users, their locations (spread out over wide-ranging locations) Users not having the correct operating system installed Speed of modem in dial-up and download Training issues Phase-in issues that would/could impact business activities /// Data Requirements /// Discuss the raw data that will comprise the input to the system and whether it is imported from another application. Include approximate typical and worst case size of file, frequency, delimiters, and any other limitations or constraints on the data format. State if any context-sensitive keys are required. Develop and include, as applicable: /// Requirement #DescriptionRS-DA-1Logical entity relationship diagramRS-DA-2Logical data flow diagram Inputs /// Describe the raw data and the format it is received in by the  SUBJECT \* MERGEFORMAT System Name and Version Number. /// Requirement #DescriptionRS-IN-1RS-IN-2 Data Requirements (New or Existing System Integration) /// Provide a description or diagram of the data flow between the  SUBJECT \* MERGEFORMAT System Name and Version Number and other Schering-Plough databases (IN and OUT). /// Requirement #DescriptionRS-DR-1Unique file names shall be utilized.RS-DR-2 Data Migration /// Explain what data migration requirements exist or what problems may be expected. Mention compatibility of databases/versions (if applicable), etc. Identify any regulatory issues surrounding migration of data. Define alternative methods for conversion, if any. Estimate conversion cost. /// Requirement #DescriptionRS-DM-1RS-DM-2 Performance Requirements /// State what specific performance criteria exist, which are measurable and testable, such as: /// Requirement #DescriptionRS-PR-1Response time (for example be downloaded via laptop in less than 3 minutes)RS-PR-2Logical data flow diagramRS-PR-3AvailabilityRS-PR-4Processing SpeedRS-PR-5StressRS-PR-6Peak load/volume/number of usersRS-PR-7Ease of useRS-PR-5Accuracy of calculationsRS-PR-8Database size & replication constrains /// NOTE: Ensure that all requirements listed are testable/measurable. /// Environmental Requirements /// Identify, as they apply, or are known: /// Requirement #DescriptionRS-ER-1Hardware platform(s)RS-ER-2Server(s)RS-ER-3Database(s)RS-ER-4Physical locations for all of the above (control room, city, building, etc.)RS-ER-5Platform(s) users will useRS-ER-6Physical location(s) of users (departments)RS-ER-7Compatibility of what other applications need be on the same platformRS-ER-8Required air conditioning power supply and ratingRS-ER-9Effluent discharge into the environmentRS-ER-10Special filters as needed Facilities Requirements /// List any special requirements that may be required to install and implement the  SUBJECT \* MERGEFORMAT System Name and Version Number. Include items, such as: /// Requirement #DescriptionRS-FR-1Conditioned power suppliesRS-FR-2Additional bench/room spaceRS-FR-3Load on HVAC system, water or sewageRS-FR-4Special or additional electrical wiring required Technology Requirements /// Define the technology required meeting the business and functional requirements of the  SUBJECT \* MERGEFORMAT System Name and Version Number. Include: /// Requirement #DescriptionRS-TR-1Technology architectureRS-TR-2I/O devicesRS-TR-3Computer platform (required vs. desired)RS-FR-4Networking requirementsRS-FR-5Environmental requirements (temperature-controlled room, etc.) ///If a vendor and specific software has already been selected, the technology requirements would as specified by the vendor, with possible modifications, as agreed to and allowed by the application. /// System Topology /// How many environments do you need. Identify all, which may include testing, training, production, development, production support, security, or any others that may be needed. /// Requirement #DescriptionRS-ST-1Testing EnvironmentRS-ST-2Training EnvironmentRS-ST-3Development EnvironmentRS-ST-4Production EnvironmentRS-ST-5Security Environment Mechanical Requirements /// Define the mechanical requirements for the system, such as: Requirement #DescriptionRS-MR-1Special tools or fixtures (safety valves, etc.)RS-MR-2Custom machinery Control Software Requirements /// Describe any requirements for control software (for example: control modules or equipment which will be programmed for specific input or output levels, user-programmable software to control special functions, etc.) /// Special Equipment Requirements /// Identify: /// Requirement #DescriptionRS-SE-1Workstations (quantity, type), which are needed.RS-SE-2Custom machinery that is not commercially available but required as part of the project.RS-SE-3Special equipment that may be needed (isolation booths for PC in clean rooms) Security Requirements The  SUBJECT \* MERGEFORMAT System Name and Version Number system must function under Schering-Plough Research Institutes security associated with the system platform and incorporated application security, as specified by the system administrator. /// State how many secure accounts will be required, the CRUD types of user roles, and with what level of access. Indicate which local or network security is required, if proxy servers are used and, if software is installed locally, if a firewall or other protection is required. Discuss the platforms and applications security approach. Address the logical and physical access to hardware. /// /// Address the following, as they apply: /// Requirement #DescriptionRS-SR-1Software accessRS-SR-2File protectionRS-SR-3Physical security requirementsRS-SR-4System access controlRS-SR-5Operator safety controlsRS-SR-6Some screens are only read-onlyRS-SR-7Certain screens be accessible to only certain levels of security access Passwords Requirement #DescriptionRS-PW-1Passwords have a Mix of Alpha and Numeric Characters: Passwords should be required to contain a unique mixture of alpha and numeric characters, such that passwords cannot be easily guessed by another user.RS -PW-2Retained Password History: Passwords can never be reused. (Verify against Corporate Policy)RS -PW-3Password entry cannot be Visible: Password entry must be masked.RS -PW-4Inactivity of Password: Passwords must be locked out after 90 days of inactivity.RS -PW-5Password Aging: System must support the ability to force passwords to be changed after a number of days, while also providing the ability to change the password at will.RS -PW-6Discrete Distribution of User Passwords: There must be a mechanism for discrete distribution of user passwords.RS -PW-7Notification Process for Change User ID Status: There must be a mechanism for deactivation of User ID upon change in status, i.e. termination.RS -PW-8Restriction On Commonly Used Passwords: The system must support a mechanism to disable use of commonly used passwords, such that passwords cannot be easily guessed by another user.RS -PW-9Blank Passwords Are Not Permitted: Passwords must not be blank.RS -PW-10Enforced Minimum Password Length: Passwords should be restricted to contain at least 5 characters. RS -PW-11Password Resets Verified by Application Security Administrator: There must be a mechanism by which only the Application Security Administrator has access to reset a password, i.e. employee forgot their password. User ID / Authentication Controls Requirement #DescriptionRS -ID-1Multiple Logons Not Permitted: System must restrict user to a single logon.RS -ID-2User Accounts Disabled after 3 Consecutive Tries: System must disable password after 3 consecutive invalid attempts at logging on.RS -ID-3Inactivity Timeout on User ID After X Number of Minutes: The system must support the ability to lock the User ID after x number of minutes of inactivity, by requiring that the user re-enter their password to continue operation.RS -ID-4Guest Account Protected or Deleted: Guest accounts must be protected from use or deleted.RS -ID-5Written Authorization for the Creation of User IDs: There must be a mechanism in place that requires written authorization prior to the creation of a User ID.RS -ID-6Notification Process for Change User ID Status: There must be a mechanism in place to notify the Application Security Administer of terminations of employment or changes in access.RS -ID-7Unique User ID/Account Supplied: System must require User IDs to be unique; User IDs may never be reused. /// If none were generated specifically for this system/project, be sure to reference the SPRI internal document/departmental SOP that govern such changes. Internal audits shall verify that such policies are followed. /// Auditing Requirement #DescriptionRS -AU-1Invalid Attempts are logged and maintained & Reviewed: The system must keep a log of invalid attempts at access to the system, and this log must be reviewed on a regular basis.RS -AU-2Audit Trail on Password History: System must keep a log of used and in use passwords.RS -AU-3Audit Trail of Backend Changes & Review: There must be a log of backend changes, and this log must be reviewed.RS -AU-4Audit Trail for Failed Attempts: The system must keep a log of failed attempts at access to the system..RS -AU-5Audit Trail for Tracking Attempts to Access Unauthorized System resources or Sensitive Information: The system must keep a log of attempts to access unauthorized system resources or sensitive information.RS -AU-6Monitoring of Operating System or Application Changes: There must be a mechanism for monitoring the operating system and/or application changes made to the system.RS -AU-7Change Control Process Documented and in Place: There must be a documented Change Control Process in place for changes to hardware, system software, and/or application software.. Internal Software Controls Requirement #DescriptionRS -IC-1User Menu Restrictions: There must be the ability to restrict access to menu items by either individual users and/or user groups.RS -IC-2Fields that are not editable: System must provide the ability designate certain fields as read-only.RS -IC-3Time Restrictions for Access: System must provide the ability to restrict access to the system based on time either hourly, daily, or monthly.RS -IC-4Version Control: The system and individual files must be version controlled.RS -IC-5User Classification of DataRS -IC-6Digital Certificates Software COTS (Commercial Off the Shelf) Requirement #DescriptionRS -SC-1Contractor/Vendor Familiar with SP Security PolicyRS -SC-2Vendor Updates/Installations DocumentedRS -SC-3Source Code Provided: Source Code must be provided or an escrow agreement must be in place.RS -SC-4Vendor Software Security Changed from Defaults & Configured to Operate Securely in SP EnvironmentRS -SC-5Configured to Operate Securely in SP EnvironmentRS -SC-6Contractor/Vendor Read and Signed Non-Disclosure Agreement Hardware Requirement #DescriptionRS -HW-1Power On Password Enabled Desktop/LaptopRS -HW-2Screen Saver Password EnabledRS -HW-3Laptop Encryption HDD Data EncryptedRS -HW-4Data of Greatest Sensitivity must be EncryptedRS -HW-5Desktop Acting as a Server Desktop / Laptop Dial-Up Controls Requirement #DescriptionRS -DC-1Data Transfer Encrypted Over Phone LinesRS -DC-23rd Party Software (PC Anywhere Secured)RS -DC-3Personal Firewall or Security Software EnabledRS -DC-4Workstation Activity Auditing NT Security Auditing Physical Security Requirement #DescriptionRS -PS-1Server Room SecuredRS -PS-2Workstation has Anti-Theft DevicesRS -PS-3Controlled Access to Computer Room /// Refer to existing departmental, RIS and SPRI SOPs, and work instructions, which define the procedures for controlling accounts and passwords (relating to uniqueness, deactivation when a person leaves the company, procedures for reactivation upon rehire, etc.) /// Audit Trail Requirements An audit trail will be required, to satisfy the regulatory requirements defined in 21 CFR Part 11. Each change and deletion should be traceable to the responsible individual, as well as a date and time stamp. /// Describe which ones are required and how they will be verified. /// Requirement #DescriptionRS-SR-1Audit Trails (System Level)RS-SR-2Identify metadata requirements Documentation Requirements /// List what user documentation is required. Discuss vendor documents vs. customized in-house documentation, specific to each user, explanation of business flow, etc. /// Requirement #DescriptionRS-DR-1Training ManualsRS-DR-2Foldout of keyboard shortcutsRS-DR-3User Manuals Maintenance Requirements Requirement #DescriptionRS-MN-1Contracts (External / Internal)RS-MN-2Routine (Scheduled) Back-up, Restore and Archiving Archiving /// Provide detailed requirements of the system relating to: Requirement #DescriptionRS -AR-1Archiving of files (procedure and frequency)RS -AR-2Back-up of the database (procedure and frequency)RS -AR-3Restore procedures System Backup & Contingency Requirement #DescriptionRS-BC-1Backups are Completed Regularly:RS-BC-2Backup Frequency includes Full System Backup, Incremental Backup, Weekly, and Monthly:RS-BC-3Backups Stored Securely Off Site:RS-BC-4Contingency Plan in Place:RS-BC-5Contingency Plan Updated Regularly:RS-BC-6Contingency Plan Tested: Business Activities Interfaces /// Describe the internal and external interfaces and the flow of the system for the typical user. Briefly outline: /// Requirement #DescriptionRS-BI-1What platform the user will be using (laptop dial-up or desktop, PC/Macintosh, Windows 95, Win NT, etc.)RS-BI-2Where the data will be coming from, via what input, what format, and from what groupRS-BI-3Frequency of use (daily, monthly, etc.) and how long of a download expectedRS-BI-4What data would be transferred/exported and to whereRS-BI-5What files require being storedRS-BI-6What reports will be generatedRS-BI-7What compatibility issues are expectedRS-BI-8The nature of the support that is required (such as help desk: 24-hour support or multilingual) /// Provide a diagram describing process dependency. As feasible, include diagrams that detail internal and external activity interfaces. /// External Interfaces /// Specify which external interfaces will control the performance of the system or the input/output data it manipulates or generates. /// User Interfaces /// Describe specific user interfaces required by the system, such as special function keys, web page/links, etc. /// Hardware Interfaces /// List in detail what hardware interfaces will the  SUBJECT \* MERGEFORMAT System Name and Version Number require, such as printers, fax machine, bar code scanner, etc. /// Software Interfaces /// List what other systems/applications will the  SUBJECT \* MERGEFORMAT System Name and Version Number interface with and provide details. /// Other Requirements /// List any other requirements which are needed, that were not mentioned anywhere else in this document. /// Requirement #DescriptionRS-OR-1RS-OR-2RS-OR-3 Traceability Matrix As part of the  DOCPROPERTY "Division - Short" \* MERGEFORMAT SPRI validation effort, a Traceability Matrix will be compiled. The purpose of the matrix, in the format of the table displayed below, is to provide testing coverage for the system being validated, by cross-referencing the requirements (Requirement Number from the  DOCPROPERTY "Title - Short" \* MERGEFORMAT URS-FRS) to the test steps executed as part of IQ/OQ or PQ/UAT (Test Script ID). /// Fill in the table below, including all detailed functions that are required of the specific system: input, output, processing, intricate details, screens, relating to the flow of the application, etc. /// #DescriptionRequirement NumberTest Script IDTest Script Title /// NOTES: The Requirement Number column indicates the unique identifier for the specific requirement described in the Description column. The Requirement Number and Test Script ID columns are required. /// /// This matrix may be included either here, as part of the Test Plan/UAT Test Scripts, the Validation Summary Report (VSR), or just referenced in any of these documents and saved as a separate document as part of the validation package. Mention here, which is the case for the validation of this system. ///     Issue Number:  DOCPROPERTY "Issue" \# #.0# \* MERGEFORMAT 1.1  CONFIDENTIAL Page  PAGE 1 of  NUMPAGES 1  FILENAME \p V:\Project Files\Current Projects\Schering-Plough\SCH0100483 - CSV Templates\5 Revised FINAL templates sent 3-13-02\User & Functional Requirements Specifications (URS-FRS) v1.1.doc  TITLE \* MERGEFORMAT User and Functional Requirements Specifications  SUBJECT \* MERGEFORMAT System Name and Version Number EMBED Word.Picture.8  Cary, North Carolina Issue Number:  DOCPROPERTY "Issue" \# #.0# \* MERGEFORMAT 1.1  CONFIDENTIAL Page  PAGE 7 of  NUMPAGES 26 '(<=?@WX / 0 6 7 K * + 5 »»»핇tttlh1B*ph$jh156B*U\]phh156B*\]phh16B*ph h15CJ$jh1CJ$U h1CJ$ h1>* h1>*CJHjh1>*CJHU h15CJ h='j^> h15CJUVmHnHuh1jh1U hh1)(=>?$*$@&a$$dha$$a$ $d*$@&a$$d)d)gdj ? 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