Regulated Product Submissions
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- 1 Regulated Product Submission Release 2
- 2 6.Regulated Product Submission Release 1
- 3 How To:
Regulated Product Submission Release 2
1. Project Information
This is the page that we will add RPS specific information RPS Meeting Calendar
The RPS Glossary contains a list of terms, abbreviations and definitions used by the RPS project.
The RPS Project Management page contains the project plan and risks/issues/change management logs.
To link to content for the Regulated Product Submission Release 2, click here RPS R2 Project
2. Requirements Subgroup Information
Meeting Schedule: RPS_Requirements_Subgroup_Meetings
To go to update Domain Analysis Model, click here RPS R2 Iteration 2 - DAM
To go to the Multi-Product Submission "DRAFT" Scenarios, click here RPS R2 Iteration 2 - Multi-Product Submissions
To go to the Multi-Regulator/Multi-Applicant Submission "DRAFT" Scenarios, click here RPS R2 Iteration 2 - Multi-Regulator Submissions
To go to updates to previous storyboards, click here RPS R2 Iteration 2 - Updated Storyboards
To go to the Business Scenarios, click here Regulated Product Submission Release 2 (RPS R2) Business Scenario Development
To go to the conceptual modeling discussion, click here Regulated Product Submission Release 2 (RPS R2) Conceptual Model
To go to the Storyboards, click here Regulated Product Submission Release 2 (RPS R2) Storyboards
To go to the Terminology Mapping Document, click here Media:RPS Terminology revised 081105.doc
3. Development Subgroup Information
4. Testing Subgroup Information
The Testing Subgroup goals and objectives are to ensure that R2 as developed meets both the requirements and the objectives set out by the team and uncovers any specific new requirements or implementation enhancements for future releases of RPS. The objective is to ensure enough varied stakeholder participation to ensure specific stakeholders get (sufficient) experience with the implementation of the RPS R2 model in order to validate that the model was implemented correctly and works for their specific needs as well as to make decisions on future requirements.
In order to create test cases you will need the test case template File:RPS R2 Test Case Template.doc. The following PDF of the RPS R2 Iteration 1 test case inventory spreadsheet captures the development tasks, time frames and resources for the development of the test cases. File:RPS R2 All Iterations Test Case Inventory.pdf For support during test case development please email support@RPShelp.com.
Test Cases to date: Domain: Medical Device Region: US FDA File:TC D2-Ex5.doc File:TC D2-Ex1b.doc File:TC D2-Ex1a.doc File:TC D1-Ex5.doc File:TC D1-Ex2b.doc File:TC D1-Ex1.doc File:TC C1-Ex4.doc File:TC C1-Ex3.doc File:TC C1-Ex2.doc File:TC C1-Ex1.doc
5. Communications Team Subgroup Information
Meeting Schedule: RPS_Communications Team_Subgroup_Meetings
To come.... communication and educational material
6.Regulated Product Submission Release 1
To link to content for Release One of the Regulated Product Submission Standard, click here []
How to view the RPS Listserve Forum and a thread of discussion, see attached Media:List Serve Forum Instructions.doc
How to download EA Lite - the Enterprise Architect Viewing tool:
1. Go to: Sparx Systems 
2. At the bottom of the page - you will see a link for EA Lite (under the zip icon); or download EA Lite, the FREE read-only version of Enterprise Architect. Registered users can distribute EALite when sharing UML models with customers and colleagues.
3. Download EA files from RPS R2 DAM page and open with viewer.