User Requirement Specification: - User Requirement Specification is the Documentation Process of System Requirement of Different Parameter i.e Business, Process, Legal, Safety , regulatory performance and quality aspects of the future system as Per Gxp and Non Gxp Requirement.
Following Parameter will be Cover in URS Documentation.
1.
Purpose:-.
The Purpose of this User
Requirement Specification (URS) to define the User requirement Specification
for System Name .
2.
Scope :-
In- Scope <Describe
the Scope>
Out-of-Scope <Describe
the Scope>
3. Overview <System Overview>
System Design <Describe System Design>
4. Requirement <Detail>
1. Business Process Requirements
2. Business Process Control Requirements
3. Security Requirements
4. Reporting Requirements
5. Interface Requirements including Data
requirement
6. Non Functional Requirement
7. Electronic Record and Electronic
8. Migration Requirements
9. Data Backup, Archive and restore requirements
10. Other Requirement
<Templete>
4.1 Business Process Requirements
|
Requirement :- |
Requirement Description |
|
|
|
|
|
|
4.2 Business Process
Control Requirements
|
Requirement :- |
Requirement Description |
|
|
|
|
|
|
4.2 Security
Requirements
|
Requirement :- |
Requirement Description |
|
|
|
|
|
|
4.3 Reporting
Requirements
|
Requirement :- |
Requirement Description |
|
|
|
|
|
|
4.4 Interface
Requirements including Data requirement
|
Requirement :- |
Requirement Description |
|
|
|
|
|
|
4.5 Non Functional
Requirement
|
Requirement :- |
Requirement Description |
|
|
|
|
|
|
4.6 Electronic Record
and Electronic Signature Requirements
|
Requirement :- |
Requirement Description |
|
|
|
|
|
|
4.7 Migration
Requirements
|
Requirement :- |
Requirement Description |
|
|
|
|
|
|
4.8 Data Backup,
Archive and restore requirements
|
Requirement :- |
Requirement Description |
|
|
|
|
|
|
4.8 Other Requirement
|
Requirement :- |
Requirement Description |
|
|
|
|
|
|
0 Comments