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Regulated Product Submissions

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Regulated Product Submission Release 2

1. Project Information

RPSr2 Project Scope Statement

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

Iteration 2

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

Iteration 1

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

Coming Soon...

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

RPS R2 Iteration 1 Overview presentation - Jason Rock: File:Overview RPS-R2-I1.pdf

Test Case Creation Process - Dottie Byrne: File:TestCaseDevelopmentProcess BostonSci.pdf

For support during test case development please email

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

Communication Documentation

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 [[1]]

How To:

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]

2. At the bottom of the page - you will see a link for EA Lite (under the zip icon); or download EA Lite[3], 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.