Business Requirement Specification Template - DOC

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Business Requirement Specification Template - DOC Powered By Docstoc
					Computer Validation Documentation




                           REQUIREMENTS


                        [SYSTEM NAME]
              [ACRONYM SPELLED OUT IF APPLICABLE]
                               SYSTEM VERSION: [X.X]


                             DOCUMENT REVISION: [X]



                       SYSTEM OWNER:
                        BUSINESS AREA:
                  SYSTEM RESPONSIBLE:
                        BUSINESS AREA:
(Company Name) -- Computer Validation Documentation
REQUIREMENTS, REVISION [X]                                                                             Page 2 of 6
[SYSTEM NAME], SYSTEM VERSION [X.X]


                                             [System Name]
                                    [Acronym Spelled Out if Applicable]
                                          System Version: [X.X]

AUTHOR:
The author’s signature indicates that this document was written for the named system to meet the [Company Name]
Quality Standard for Computer Validation requirements for system documentation.


Signature                                                 Initials     Date                               Unit
[Typed/Printed Name]

[Since approvals differ from business area to business area, the approvals shown are the minimum that
should be considered on a Computer Validation Plan. The business area may add or subtract signatures as
required.]

                               REVIEW AND APPROVAL SIGNATURES
The signatures below indicate that this document meets the [Company Name] requirements for documenting
business area requirements, while accurately reflecting the business area functional requirements for the named
system.

REVIEWED BY IT RESPONSIBLE (IF REQUIRED BY THE BUSINESS AREA.)


Signature                                                 Initials     Date
[Typed/Printed Name]

APPROVED BY QUALITY ASSURANCE (REQUIRED):


Signature                                                 Initials     Date
[Typed/Printed Name]

APPROVED BY SYSTEM RESPONSIBLE (IF REQUIRED BY THE BUSINESS AREA.)


Signature                                                 Initials     Date
[Typed/Printed Name]

APPROVED BY SYSTEM OWNER OR DESIGNEE (REQUIRED):


Signature                                                 Initials     Date
[Typed/Printed Name]




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(Company Name) -- Computer Validation Documentation
REQUIREMENTS, REVISION [X]                                               Page 3 of 6
[SYSTEM NAME], SYSTEM VERSION [X.X]



                                         Table of Contents




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[SYSTEM NAME], SYSTEM VERSION [X.X]


[Instructions for completing this document: Delete the pink text and this section from the final
version of the document. It is included for informational purposes only.

Requirements must be traceable to user testing, and be written in such a manner as to be testable
and/or verifiable. It should be recognized that one testable statement in the Requirements often
results in several test procedures in the test plan. Requirements serve as a source of information
for developing test plans to verify that the computer system was properly designed and
developed. Requirement statements must contain unambiguous, testable statement of sufficient
detail that test conditions with expected results can be written.]
                         1.
1.     SCOPE
       This document establishes the [Company Name] [name of business area] business and
       technical requirements for [name of the system and version number].

2.     OVERVIEW AND OBJECTIVE
       [Provide a summary of the problem that describes the main concepts of the solution and
       the objective to be achieved with the solution.]

3.     BUSINESS JUSTIFICATION
       [Describe why the business needs this computer-based solution.]

4.     BUSINESS REQUIREMENTS
       [Provide the business requirements that describe the basic work process or business
       process, and how and/or where the computer system will fit into that process (i.e. steps
       that will be automated). Spreadsheets, flowcharts, the process model, or similar
       documentation can be attached if applicable.
       4.1     BASIC WORK/BUSINESS PROCESS
               4.1.1 Requirement
               4.1.2 Requirement
       4.2     PROCESSES TO BE AUTOMATED
               4.2.1 Requirement
               4.2.2 Requirement

5.     TECHNICAL REQUIREMENTS
       [Describe the current technical environment and the proposed new technical requirements
       for improving/correcting the current technical environment (include performance
       requirements, hardware requirements, and operating environment). Describe what
       technical requirements are necessary to meet the stated business requirements. Depending
       on the complexity of the system, these requirements may be a separate document or
       included in the Specification document. There is a separate Specifications template, as
       well as a Requirements and Specifications template for smaller systems/validations.]
       5.1     HARDWARE REQUIREMENTS
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[SYSTEM NAME], SYSTEM VERSION [X.X]


               5.1.1 Requirement
       5.2     SOFTWARE REQUIREMENTS
               5.2.1 Requirement
               [Address if hard-coded configuration (not changeable) is required from the vendor
               for the proposed software, or if in-house configuration (resetting flags in the code)
               will be utilized.]
6.     FUNCTIONAL REQUIREMENTS
       [Address what the system is required to do.]
       6.1   DATA ACQUISITION REQUIREMENTS
             6.1.1 Requirement
       6.2   DATA ANALYSIS REQUIREMENTS
             6.2.1 Requirement
       6.3   DATA OUTPUT REQUIREMENTS
             6.3.1 Requirement
7.     SECURITY AUTHORIZATION REQUIREMENTS
       [Describe the security requirements for the proposed solution/software. Some questions
       to consider are: Does the solution require sophisticated logical access controls? Does
       more than one user, with different levels of access, need to access the same data?
       Security requirements impact the design and maintenance of the computer system.]
       7.1     PHYSICAL SECURITY
               7.1.1 Requirement
       7.2     LOGICAL SECURITY
               7.2.1 User ID
               7.2.2 Password
8.     COMPLIANCE REQUIREMENTS
       [Address all compliance issues, such as architecture, security, regulatory, legal, electronic
       record, electronic signature requirements, etc. These items can impact the design and
       maintenance of the computer system.]
       8.1     GXP SYSTEM
               [Address whether or not the system is required to be GxP and the impact the
               system will have on the XXXX, or if will perform a function(s) specifically
               required by GMP, GCP, GLP regulations.]
       8.2     DATE/TIME ISSUES
               [Address year 2037, leap years, time zones (if applicable) century, military time,
               etc.]
       8.3     COMPANY OFFICE AUTOMATION REQUIREMENTS
               [Address whether or not the operating environment is required to be in
               compliance with company standards.]
       8.4     21 CFR PART 11 – ELECTRONIC RECORDS AND ELECTRONIC SIGNATURES

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[SYSTEM NAME], SYSTEM VERSION [X.X]


               [Address the company policy and how the policy and regulation relates to this
               system.]
       8.5     AUDIT TRAIL
               [Address requirements for audit trail.]
       8.6     DATA RETENTION
               [Address the company policy on records retention and how those relate to the
               requirements of this system.]

       8.7     PREDICATE RULES
               [Address the GLP GCP GMPs that must be met or address by the named system.]
9.     OPERATE, SUPPORT, AND USE REQUIREMENTS
       9.1  SYSTEM OPERATION AND SUPPORT REQUIREMENTS
       9.2  SERVICE/MAINTENANCE REQUIREMENTS
            9.2.1 Geographic Distribution
            9.2.2 System Use Statistics
                   9.2.2.1 Number of Users [range]
                   9.2.2.2 Number of Transactions [estimate]
                   9.2.2.3 Volumes of Data [Estimated amount of data. This info is used to
                           determine the amount of disk space used for data retention.]
                   9.2.2.4 Disaster Recovery/Business Continuity [Info used to determine
                           what Infrastructure needs to put in place.]
10.    DATA REQUIREMENTS
       [Provide a detailed description of data requirements (including data model) for the
       proposed computer solution.]
11.    TEST REQUIREMENTS
       [Each business/technical requirement stated in this document will be tested. Provide any
       additional information required for successful user testing of the proposed computer
       solution. Address any special testing requirements, such as whether or not automated
       testing tools will be required.]
12.    GLOSSARY OF TERMS
       [Optional.]
13.    APPENDICES
       [Optional.]




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