Attachment 3 CSTAR Task Order 2 SOW.doc

Attachment 3

Task 2 – CSTAR Architecture and Interface Refresh (Labor Hour) Background As the original system in the CSTAR (Center Submission Tracking and Reporting) suite of applications, the Center Tracking System, or CTS, has gone from supporting a subset of premarket business processes and a subset of users in a single division to supporting many other areas of CDRH, including postmarket, compliance, and RadHealth. The true strengths of CTS are its strong alignment with CDRH business processes and its widespread acceptance by the user community. CTS is where and how people do or track much of their work. Users are generally well familiar with the features and the functionality offered by CTS.

While CTS has an engaged and supportive user community, it does have a number of technology-oriented shortcomings that prevent CDRH from utilizing the system to its fullest potential. Much of the system is custom code, with embedded business rules and a lack of modularized features. Although CTS integrates with other systems, most of the interchange occurs through backend database connections. No application program interface (API) or web services architecture exists within CTS for exchanging information. These limitations hinder CDRH from incorporating major new functionality, adding complicated business processes, or reworking legacy functionality in a sustainable, cost-effective manner.

Likewise, although the CDRH Ad-Hoc Reporting System (CARS) has been in production in 2007, it has not met the expectations of the user community due to technical limitations, unsatisfactory user interfaces, and data quality issues. CARS is CDRH’s data warehouse that integrates data from various operational systems and loads data from these systems at regular intervals. CARS is geared towards the business intelligence and reporting requirements of the Center.

In preparation for the new contract, CDRH business management has purposely delayed some of the requested major enhancements to the existing CTS and CARS systems. Therefore, this task will be used to refresh the architecture and interface of the systems in conjunction with deferred high-priority enhancements.

Objective The primary objective of this task is to perform FDA Enterprise Performance Life Cycle (FDA EPLC) Development, Modernization, and Enhancement (DME) activities to assess and implement architecture and interface changes to the CTS and CARS systems in conjunction with specific enhancement requests.

The Government seeks innovation in suggesting technology improvements, which will create a more extensible and scalable foundation for the integration of future capabilities, features, and system integrations.

At a minimum, the contractor shall work with designated government personnel to assess the baseline systems and recommend and implement the best approaches to the following deferred high-priority enhancements:

CTS - Center Tracking System

· Consult Architecture Improvements - Develop a web service version of the CTS eConsult module that facilitates the creation of both associated and standalone Consults from other CDRH applications, and implement a capability within CTS to uniquely reference any and all Consults, including associated and standalone;

· User Interface Enhancements - Replace the current expandable/collapsible vertical window view with a tab-based view, per requirements gathered from the CDRH business community, ensuring that any modifications are compliant with Section 508 of the Rehabilitation Act of 1973;

· Improved Search/Reporting - Establish improved searching/reporting capabilities to enhance analytics and business activity monitoring (BAM) capabilities as per requirements gathered from the CDRH business community;

· Document Management Integration – Utilize Content Management Interoperability Services (CMIS) and Apache Chemistry to provide CMIS-compliant document management repository services to CTS users as per requirements gathered from the CDRH business community;

CARS - CDRH Ad-Hoc Reporting System

· Architectural Performance Enhancements - Optimize the data warehouse architecture, design, and ETL processes to reduce back-end loading time and to improve front-end performance of queries and reports;

· Improved Data Quality - Resolve data quality issues within the data warehouse and work with source transactional system owners to help resolve their data anomalies;

· User Interface Improvements - Implement additional reports, dashboards, or other visual analytics, per requirements gathered from the CDRH business community, to improve the user experience.

Description of Work

In conjunction with all relevant terms, conditions, requirements and guidance of the CENTER SUBMISSION TRACKING AND REPORTING contract, the contractor shall analyze, document, design, develop, test, and implement a FDA-specified solution, according to EPLC and FDA IT standards. These practices also include the use of software development life cycle tools, including JIRA (change requests), Subversion (source code), and Traction (documentation). Overall Program Management (PM) support shall be provided throughout the performance period using internal processes consistent with principles outlined in the Project Management Institute’s (PMI) PMBOK® Guide.

The contractor’s work shall be performed in accordance with tailored EPLC processes and templates, including Stage Gate Reviews. For this task, the contractor shall be required to perform the following work, in an iterative fashion, for these FDA EPLC phases:

1. Initiation & Concept Phase Within the FDA EPLC framework, the Initiation Phase and Concept Phase shall be combined into one phase to assess the current CTS and CARS systems. The purpose of this combined phase is to: 1) Identify significant assumptions and constraints on potential solutions relative to the business objectives, and 2) Explore alternative concepts and methods to satisfy the business requirements. The contractor shall be required to perform the following work in this phase:

CTS - Center Tracking System

· Focusing on the CTS Objectives defined earlier, perform an assessment of the relevant, current CTS architecture, features, and interface through inspection, reviews, and interviews;

· Document CTS findings, gaps, and recommendations and identify EPLC system artifacts that need to be updated;

· Present CTS findings, gaps, and recommendations formally to the FDA COTR/Project Manager, CDRH business management, and other identified stakeholders;

CARS - CDRH Ad-Hoc Reporting System

· Focusing on the CARS Objectives defined earlier, perform an assessment of the relevant, current CARS architecture, features, and interface through inspection, reviews, and interviews;

· Document CARS findings, gaps, and recommendations and identify EPLC system artifacts that need to be updated;

· Present CARS findings, gaps, and recommendations to the FDA COTR/Project Manager, CDRH business management, and other identified stakeholders;

From this point, using the knowledge attained from the assessment and gap analysis, the CTS and CARS teams will independently perform the same EPLC-based activities to implement the agreed-upon approach for the deferred high-priority enhancements identified in the Objectives section and any other recommendations that the Government approves.

2. Planning Phase

The purpose of the Planning phase is to apply project management rigor by ensuring that project work is broken down into specific tasks and subtasks and that milestones are established. The contractor shall be required to perform the following work, based on the Objectives, in this phase:

· Formalize the EPLC Project Process Agreement (PPA);

· Review and update, as necessary, the Project Management Plan;

· Develop the Project Schedule for the release;

· Hold an internal Stage Gate Review to ensure the Government and Contractor agree upon the scope for the release.

3. Requirements Analysis Phase

The purpose of the Requirements Analysis phase is to establish the functional and non-functional system requirements. These system requirements will further define the enhancements in more detail with regard to inputs, processes, outputs, and interfaces, providing the basis for alternative technical solutions. The contractor shall be required to perform the following work, based on the Objectives, in this phase:

· Plan, schedule, lead, and document the system requirements gathering sessions;

· Create, review, or update the Systems Requirement Specifications (SRS) to capture the functional and non-functional requirements;

· Supplement the validation of written system requirements using graphical means, such as, but not limited to, prototypes, context diagrams, mockups, flow diagrams, wireframes, functional decomposition diagrams, storyboards, use cases, scenarios, etc;

· Validate, update, and maintain the Data Dictionary;

· Design and update the Logical Data Models;

· Schedule, facilitate, and document the outcome of reviews and sign-off meetings with the Integrated Project Team (IPT) and business community;

· Hold a Stage Gate Review to ensure the project passes the exit criteria of critical partners before proceeding to the next phase.

4. Design & Development Phase

Within the FDA EPLC framework, the Design Phase and Development Phase shall be combined into a single “Design & Development” phase. The purpose of this combined phase is to develop detailed design specifications, emphasizing the physical solution, which will be transformed into machine-executable form. The solution will ensure that all of the individual components of the business product function correctly and interface properly with other components. The contractor shall be required to perform the following work, based on the Objectives, in this phase:

· Perform the design of the system based on the detailed requirements;

· Update the System Design Document;

· Design and update the Physical Data Models;

· Review and update the system requirements for accuracy and completeness while the system enhancements are being designed and developed;

· Update the Data Dictionary as necessary;

· Create or update the Interface Control Document (ICD);

· Implement the solution according to the system design;

· Ensure that the solution is 508 compliant;

· Create or update the System Architecture Document;

· Prepare the Version Description Document (VDD) for the release;

· Perform thorough unit testing of the enhancements;

· Create the Software Unit Test Report;

· Start developing testing artifacts (plans and test cases) for the Test Phase;

· Provide input into security documentation created by OIM staff;

· Hold a Stage Gate Review to ensure the project passes the exit criteria before proceeding to the next phase.

5. Test Phase

The purpose of the Test phase is to perform controlled and focused testing to uncover errors and bugs in the business product and to fix them before final implementation. The contractor shall be required to perform the following work, based on the Objectives, in this phase:

· Finalize the Master Test Plan and Release Test Plan;

· Finish the detailed Test Case Specifications;

· Create, review, or update the Requirements Traceability Matrix (RTM) to validate the requirements;

· Perform thorough functional testing, integration testing, and regression testing of the enhancements;

· Start developing updates to the Operations and Maintenance Manual;

· Fix bugs and errors uncovered during testing, re-deploying to the environments, and re-testing;

· Support user acceptance testing (UAT);

· Provide input into security documentation created by OIM staff;

· Hold a Stage Gate Review to ensure the project passes the exit criteria before proceeding to the next phase.

6. Implementation Phase

The purpose of the Implementation Phase is to install and deploy the solution in FDA’s production environment. The contractor shall be required to perform the following work, based on the Objectives, in this phase:

· With user acceptance and passed tests, deploy the release to production;

· Provide post-deployment input in security documentation;

· Provide post-deployment input into a Contingency and Disaster Recovery plan;

· Finalize updates to the Operations and Maintenance Manual.

Assumptions

1. After each successful production deployment of CTS and CARS DME releases, the enhancements will be maintained through the Operations and Maintenance (O&M) task.

Key Personnel

The following is a list of key personnel and associated responsibilities that are minimally required for this effort:

· Principal Systems Architect - In addition to any qualifications required by this labor category under the contract, the Principal Systems Architect must have the following qualifications:

· Knowledge/experience developing web services

· Experience in developing applications/services in a service oriented architecture (SOA)

· Experience in developing applications/services in a Java environment

· Senior Computer Systems Analyst - In addition to any qualifications required by this labor category under the contract, the Senior Computer Systems Analyst must have the following qualifications:

· Knowledge/experience of business analysis standards and methodologies

· Experience in analyzing and modeling business processes

· Senior Systems Architect - In addition to any qualifications required by this labor category under the contract, the Senior Systems Architect must have the following qualifications:

· Knowledge/experience developing Business Objects reports and services

· Experience in developing applications/services in a database environment using end-user metadata for analyses and implementation

· Database Management Specialist - In addition to any qualifications required by this labor category under the contract, the Database Management Specialist must have the following qualifications:

· Knowledge/experience designing and administering Oracle-based data warehouses

Government Furnished Information/Government Furnished Equipment

FDA will provide laptops, tokens (fobs), and any essential accessories along with FDA network access along with FDA network access to all members under this task order. FDA will provide the development, test, pre-production, production and any other server based environment necessary to accomplish the stated work.

Place of Performance

The contractor will be required to interact with FDA staff in multiple locations throughout the Washington, DC metropolitan area. All CDRH business staff is located at FDA’s White Oak campus in Silver Spring, MD. FDA’s Office of Information Management (OIM) staff is located at facilities in the Rockville, MD area. As of now, the Government expects that space for contractor staff will be available at an FDA site, but space has become more of a premium recently. Therefore, the contractor shall be prepared to work offsite at its own facility, at any point, during this period of performance.

Deliverables

The EPLC deliverables were specified earlier in the Description of Work section, and in addition to those, this task requires the following:

Business Management

Business Management

Business Management

Business Management

Minutes – 3 working days following the meeting

COTR/PM

Business Management

Projected Schedule CDRH anticipates that the period of performance for this task will be 12 months from contract award. The period of performance is based on the project start date per the EPLC framework. The Contractor shall inform the FDA COTR/Project Manager, CDRH business management, and Contracting Officer, in writing, of the official project start date.

Note: All functional and technical improvements in a release will be agreed upon by the FDA COTR/Project Manager, CDRH business management, and the contractor, per FDA EPLC guidelines, and will fall within the budget and period of performance for this task order. Change Control Requests (CCRs) from DME tasks may be grouped with O&M/SS activities in a single software release to limit the number of deployments.

CTS – Center Tracking System

CARS - CDRH Ad-Hoc Reporting System