Amendment_0002_Attachment_E_Initial_ORA_IPS_TO_SOW_FINAL.docx

Office of Regulatory Affairs (ORA) Information Technology Program and Project Management Support Services (IPS) Initial Office of Regulatory Affairs (ORA) Task Order Statement of Work

Table of Contents

Background The FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health. FDA also has responsibility for regulating the manufacturing, marketing and distribution of tobacco products to protect the public health and to reduce tobacco use by minors. Finally, FDA plays a significant role in the Nation’s counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

The U.S Food and Drug Administration, Office of Regulatory Affairs (ORA) mission is promoting public health and safety by ensuring industry compliance with applicable laws and regulations. Information Technology (IT) is a key component of ORA’s enforcement toolbox.

The systems utilized by ORA are grouped into three major investments: Mission Accomplishment and Regulatory Compliances Services (MARCS); Regulatory Information Business Services (RBIS); and Automated Laboratory Management (ALM). Each of these investments manages multiple development projects, as well as maintenance and operations.

The current applications (not to be confused with systems) managed under these three investments are developed and maintained by other contracts. For context, a brief description of their current capabilities, complexity and environments are listed below:

· COMSTAT, the Compliance Status Information System is a Subsystem of MARCS-FACTS (Field Accomplishments and Compliance Tracking System) that summarizes key quality assurance information about facilities that manipulate drugs, devices, and certain biologics and makes that information available to external customers.

· eLEXNET, the Electronic Laboratory Exchange Network, provides the ability to compare and communicate data from laboratory analyses of food products as well as to detect unusual results and identify potentially harmful products. This includes:

· Records and Content Management

· DRUPAL (a free and open-source content management framework) will be replacing the COTS (Commercial off-the-shelf) Oracle Portal community inside of eLEXNET. The Oracle propriety software does not allow for mass migrations of records; support will be needed to manage, maintain, and migrate over 10,000 historical records to the new community structure within the CMS (Content Management System) tool (DRUPAL), while maintain compliant with record managements best practices. The migration of historical data records from the Oracle Portal Community functionality to DRUPAL content management will support and complete the 11g DME (Development, Modernization or Enhancement) task.

· CMS tools – managing, maintaining and migrating within FDA SharePoint and eLEXNET’s DRUPAL artifacts. The addition of numerous contractors, vendors and tools requires a restructuring and designing an efficient collaboration folder structures.

New DME Technical Standards & Methods / Tools & Techniques

· Numerous new DME activities, tools, are expected to be implemented within eLEXNET including iDAT, DRUPAL, Oracle BPM (Business Process Model), DROOLS ( a business rule management system), Data Exchange Standardization (DXS), FACTS&LIMS interfaces, APHL(Association of Public Health Laboratories) outreach activities, synchronization and bi-directional interfaces, etc.

· ORA require standards and methods that are consistent with technical standards and methodologies to support Program level management oversight. Assistance is needed to stay in compliance with this standards, as well as, basic project/program management best practices.

· eSAF, the electronic State Access to MARCS-FACTS, is an interface to MARCS-FACTS (see below) that collects information from state investigators, so that FDA can leverage their work.

· MARCS-FACTS, the Field Accomplishments and Compliance Tracking System, provides functionality that supports workload management, sample collections, sample analyses, consumer complaints, inspections and investigations, compliance operations and management of information about the firms regulated by the FDA.

· FMLS, the FIRMS Master List Service, was initially developed to clean up ORA’s list of firms. This capability was later leveraged to validate the registration of firms, submitted in response to the prior notice provision of the Bio Terrorism Act. Additionally, FMLS’ capability is being expanded to include the validation of information received from CBP (Customs and Border Protection)’s Automated Commercial System (ACS) and other registration systems in the FDA’s extranet.

· IMF, the International Mail Facility Prototype, interfaces with CBP systems to track the disposition of imported prescription drugs seized by Customs. IT was built under tight deadlines, using the TurboEIR notebook framework to respond to a change in CBP’s international mail processes.

· MI, the MARCS Interface project, is the front end of MARCS, Currently under development, it will implement a single access point for all ORA systems, control administration of roles and responsibilities, and provide a single interface to numerous Center databases, used by import reviewers during their investigations.

· MARCS-OASIS, ORA’s Operational and Administrative System for Import Support is a 24/7 mission critical system. MARCS-OASIS fully automates the screening and supports human review of the 18 million+ products lines received each day from CBP. Additionally, MARCS-OASIS provides a selective screening and review process for the 14 million products that submit PNSI (see next).

· PNSI, the Prior Notice System Interface to MARCS-OASIS, gives the public a means to submit prior notice that a food product is being shipped into the country without using a private broker to submit an entry through CBP.

· OPAS, the Online Program Analysis System, provides DPEM the data needed to respond to special requests for information from Congress, other Government agencies, and the public, particularly that related to accountability for Prescription Drug User Fee Act (PDUFA). OPAS also allows FDA to make risk based decisions and thus OPAS aligns tightly with part of the FDA strategic mission.

· ORADSS, ORA’s Decision Support System, the central information repository of the data warehouse, shares data with most ORA systems. Currently, it provides users with a single source for the information captured by FACTS, OASIS and Recalls Enterprise System (RES). In addition, it provides users with the tools to access information easily and rapidly. ORADSS will play the same role for MARCS.

· RES, FDA’s Recalls Enterprise System, captures, maintains and reports information about all product recalls of FDA interest. It replaces the stand-alone systems maintained by each Center. When fully implemented, it will be the public face of all FDA recall information on the Web.

· SERS, the Standardized Evidence Repository Service, is in development to meet ORA’s program needs for a module to control access to a repository for evidence collected during or generated by inspections and investigations. SERS will also support the needs of compliance activities in ORA and the Centers by linking data collected through multiple sources through standardizes meta data use.

· LIMS, the Laboratory Information Management System, is a Commercial off the shelf (COTS) product “suite” from a single vendor or a collection of COTS components from multiple vendors and/or custom code which, when fully and efficiently integrated, fulfills FDA enterprise and specifically ORA Laboratory and Field requirements as regards samples, sampling, and sample analysis within legal and scientific controls and parameters. Future planned development work include the LIMS solution to be integrated with ORA and other FDA systems, such as Mission Accomplishments and Regulatory Compliance Services (MARCS), Regulatory Business Information Services (RBIS), and other Automated Laboratory Management (ALM) systems, including the Quality Management Information System (QMiS) and the Electronic Laboratory Exchange Network (eLEXNET).

· QMiS - Quality Management Information System (QMiS) supports program quality, process standardization and improvement of Quality Managers performance in ORA. Quality Management Information System (QMiS) complements and supports the ORA Quality Management System (QMS). Nine QMS procedures are implemented and managed/controlled using QMiS: 1.) Document Control and Management, 2.) Control of Records, 3.) Management Review, 4.) Audits, 5.) Control of Non-Conforming Processes, Services and Products, 6.) Continual Improvement, 7.) Corrective Action, 8.) Preventative Action, and 9.) Complaints/Feedback.

· MDM (Master Data Management) - The FDA's collection of Establishment data continues to experience significant growth. At the same time, there is a heightened need to improve data quality and data sharing across the FDA. These two factors compel the FDA to implement a comprehensive, modern enterprise MDM platform to manage shared critical business information on firms and facilities. The MDM project will develop an MDM strategy and roadmap; gather business, functional, and technical requirements; conduct business and systems impact analyses; develop and implement governance and standards processes for the maintenance of the firm and facility data; initiate the MDM Pilot using the off-the-shelf MDM solution by Informatica with the goal of publishing a “Golden Record” of the regulated assets for use across the FDA. The goal of MDM is to:

· Improve timeliness and availability of data and information

· Improve quality of information to reduce time in decision making

· Free up time from data gathering & analysis to value-add analysis

· Create a shared behavior with metrics to ascertain progress and process improvements

· Connect the dots between different IT groups, the business and data stewards/governance groups

· Determine proper resource loads within a scalable repeatable

Additional information about the investments (programs) and corresponding projects is provided on the FDA IT Dashboards. The dashboards for these three investments are provided on the Federal IT Dashboard websites at https://itdashboard.gov/investment?buscid=310, (MARCS), https://itdashboard.gov/investment/project-summary/318?order=data_controller_column_3&sort=asc (RBIS), and https://itdashboard.gov/investment/project-summary/299?order=data_controller_column_2&sort=asc (ALM).

Objectives The objective is to provide Information Technology Support Services to the Office of Regulatory Affairs Business investments throughout all phases of Enterprise Performance Life Cycle (EPLC).

Project Task Order Scope IPS support includes: program management services concept development and project initiation, configuration design and functional area analysis, program and systems analysis and modeling, quality assurance, service oriented architecture, audit activities as well as mentoring and program and project coordination support, senior and junior level assistance with the daily management of their projects including administrative assistive and process tools, documentation, and privacy implementation.

These services include knowledge transfer in a wide range of activities including: project initiation, planning, preparing and overseeing project schedules, maintaining spreadsheets to track cost expenditures (Monthly Contract Financial/Activity Status Briefing); Interacting with various points-of-contact for specific tasks regarding progress, issues and concerns; Preparing reports and briefs; management in support of project goals; Developing and reviewing requirements and monitoring their implementation & applications, to ensure that business needs are met; Providing business and technical expertise to assist in planning and managing FDA projects; Providing technical writing capabilities in support of technical and program management project decision-making, and monitoring program status and relating any trends as they become known.

The ORA Project Matrix in Section 4.5 Support of FDA Software Releases and Infrastructure Upgrades, documents the three major ORA investments, the estimated number of projects by system, and the number of projects by life cycle phase.

1 Description of Task Area Work The Contractor shall furnish all necessary services, qualified personnel, material, tools and methodologies, not otherwise provided and subject to approval by the FDA, as needed to perform IT program support services. Artifacts shall meet organizational standards or be of a quality that leads to adoption as organizational standards (such as meeting the criteria for acceptance in the Capital Planning and Investment Control (CPIC) portfolio system for investment type work).

Transition Activities Transition activities efficiently transfer the task order requirements from the incumbent Contractor to the new Contractor. The Contractor shall support transition-in and out activities.

Transition-In The Contractor shall develop a Transition-In Plan to describe Transition‐In services in order to provide an orderly transition of work activities, products and knowledge from the incumbent Contractor to the new Contractor. The Contractor shall work toward the Government’s goal of ensuring minimal disruption to ORA’s investments and projects.

The Contractor shall:

· Develop and maintain Transition‐In plan to successfully transition existing support services from incumbent contractors

· Participate in Transition‐In meetings

· Participate in knowledge transfer activities such as “shadowing”

· Conduct and coordinate all on‐boarding activities with the Government and obtaining secure badging for team personnel

· Ensure staff identified as key personnel are available to work with Subject Matter Experts (SME) from the Government and the incumbent Contractor immediately after Task Order award

· Engage in regularly scheduled meetings.

Concept Development and Strategic Planning The Contractor shall provide services for IT concept development and strategic planning. The Contractor shall perform the following tasks:

· Participate in early phase Stage Gate and Baseline Reviews

· Assist various program staff in developing the high level business models and define business requirements at the level needed for Concept evaluation and approval by FDA management

· Format and finalize (edit) Initiation and Concept Phase documents

· Review EPLC deliverables, such as: Business Needs Statements and or Issue Papers, Business Case, Operational Assessment, Project Charter, Boundary Documents, Initial Project Management Plan, Privacy Impact Assessment

· Document business needs in Issue Papers, Boundary Documents, Concept Documents, and Concepts of Operations

· Assist FDA program staff involved in planning and executing FDA regulatory processes in the gathering and documentation of requirements

· Participate in strategic planning sessions to recommend analysis of alternative approaches; to include the tentative 64 software releases and infrastructure upgrades listed in Section 4.5 - Support of FDA Software Releases and Infrastructure Upgrades.

· Participate in the planning activities required by OMB, HHS and the FDA EPLC and document the results: (i.e. Cost benefits analysis; Risk assessments; Alternatives analysis)

· Assist FDA in establishing performance goals and metrics

· Assist FDA in development of functional and system requirements for FDA systems

· Conduct requirements review and analysis of functional, system, and user requirements documents

· Participate in programs working groups and provide technical input into regulatory/rule development where appropriate

· Review requirements for proofs of concept or prototypes to help prove technical concepts

· Review cost, schedule, and scope estimates for future acquisitions, and/or provide input/recommendations to facilitate informed management decisions

· Review technical concept designs and recommend approaches for implementation

· Perform Program/Project investment analysis

· Assist FDA in updating and developing Business Cases (Approximately 3 updates planned for each project per year)

· Review processes for specific program or project repository content management and ownership

· Provide technical and business expertise to assist Government staff in evaluating alternative approaches to meeting the objectives defined in the Initiation and Concept phase documentation.

· Meet with FDA Program staff to support the technical decisions for investments

· Meet FDA program staff involved in planning and executing regulatory processes

· Interact with FDA staff to ensure that systems will support FDA cross- cutting initiatives

· Generate Concepts of Operations, white papers, briefings, Process Agreements

· Provide Cost Benefit Analysis of a particular approach or technology and prepare recommendation(s) Program and Project Control The Contractor shall provide Information Technology Support and Program Management Support Services for ORA’s project management teams to help facilitate the execution of daily program management planned tasks, reviews, and technical activities performed under this Task Order. The Contactor shall:

· Maintain and follow up on tasks/action items for the IT project management team;

· Facilitate, participate, and provide support for project status, planning, and deliverable review meetings for project schedule;

· Monitor, review, and track status updates of development contractor deliverables; provide quality control; and present recommendation(s)

· Review, identify, and document project risks, and facilitating mitigation strategies development;

· Providing expert consulting on software development, IT processes, project management best practices, and solution approaches, etc.

· Monitoring and reviewing IT project performance

· Supporting the IT project quality monitoring and standards enforcement

· Support the performance of project health checks and post-project reviews Program and/or Project Planning The Contractor shall:

· Provide expert consulting on software development, IT processes, project management best practices, and solution approaches, etc.

· Provide estimating, scheduling and risk management expertise to IT PM teams

· Maintain document repositories, collaboration tools, updating project artifacts to SharePoint and Enterprise Content Management System (ECMS), and folder structure;

· Provide support in developing requirements documentation – including project plans, Work Breakdown Structure (WBS), communication plans, and collaboration tools for licenses, instrument support and supporting applications;

· Support SOW development, provide technical writing support of technical and program/project management project decision-making, monitoring program status and relating any trends, as they become known.

· Perform quality assurance and present recommendation(s) on EPLC artifacts Support of FDA Software Releases and Infrastructure Upgrades The Contractor shall support and facilitate planning for software releases and infrastructure upgrades. The Contractor shall provide services to develop plans for individual software releases and infrastructure upgrades. A few upgrades are major projects (will be identified by COR), but most are small and do not require major project planning as described under the planning activity. The distribution of releases will be as follows tentatively:

Systems/Major Investments

O&M 3-5/month Avg. 5 per project

The Contractor shall provide full EPLC artifacts reviews on major releases only. Minor releases will have document review and support from tailored EPLC process specific to the release. The Contractor will support the FDA overview for these activities in support of software and infrastructure release planning and shall perform the following activities:

· Scheduling - Prepare and oversee work plans and schedules.

· Issue Resolution - Use technical, and subject matter expertise to resolve business and technical issues and document.

· Technical Support - Interpret system requirements and review deliverables

· Risk Management - Conduct ongoing assessments of potential risks assessments and following through on mitigation strategies where needed.

Develop and Document Program-Level Technical Standards & Methods

ORA’s IT investments are programs made up of multiple interrelated projects. In addition to project planning, ORA, requires projects to adhere to standards and methods that are consistent at the investment level such as IT Standards applicable to the projects include adherence to the FDA’s Enterprise Performance Life Cycle, (EPLC) applicable federal security and privacy regulations and directives, and other capital investment management and reporting requirements. The Contractor shall:

· Participate in reviews that focus on the ORA’s existing technical standards and methodologies to that support Program level management oversight.

· Provide suggestions for improvements to standards and methods. Program level technical standards and methods currently under development include:

· Change Management

· Integrated Scheduling and Investment Roadmaps

· Program artifact Configuration Management.

· Service Oriented Architecture

· Other Program Level standards and/or Methodologies.

The Contractor shall document this research and suggestions in Recommendations for Technical Standards & Methods Paper, to be produced periodically as recommendations are identified.

Research and Recommend New Tools and Techniques The Contractor shall research and recommend new tools or techniques that could be useful in meeting ORA’s IT investments and FDA’s mission needs. Such analyses may include research and lessons learned in other related environments. All analysis activities that are appropriate to the existing product or process should be taken into consideration while doing research and recommending new tools and techniques.

Numerous new DME activities, tools, are expected to be implemented (for example, within eLEXNET: iDAT, DRUPAL, Oracle BPM (Business Process Model), DROOLS ( a business rule management system), Data Exchange Standardization (DXS), FACTS&LIMS interfaces, APHL(Association of Public Health Laboratories) outreach activities, synchronization and bi-directional interfaces, etc.)

Recommendations made by the Contractor shall be aligned with ORA’s requirements for uniform standards and methods are uniform, in compliance and follow best practices, as applicable. The Contractor shall document this research and resulting recommendations a Recommendations for Tools and Techniques Paper, to be produced periodically as recommendations are identified.

Process and Procedure Improvements The contractor shall provide ongoing review of existing Software development life cycle processes and procedures discussed in project meetings and artifacts to identify areas of where improvements can be made and to recommend ways to make changes that will benefit the quality, efficiency and/or effectiveness of the ORA’s IT software products(Including infrastructure projects). The Contractor shall participate in regular meetings to provide collaborative opportunities to discuss and share suggestions for improvements. The Contractor shall:

· Participation in ORA and/or FDA working groups.

· Reviewing SDLC deliverables and providing comments/recommendations as appropriate.

The Contractor shall document potential process and procedure improvements in a Process and Procedure Improvements Paper, to be prepared as improvements are identified.

Support With and Using Business Tools The Contractor shall provide business tool services to leverage the features available for use in the product, whether acquired in house or commercially, and enhance the presentation layer of a product that is in use at FDA. Examples of areas for support include the user configurations for graphic user interfaces (GUI) such as office suite software, content, collaboration and knowledge management software, and visual basic code. Typical business tool recommendations include the type of configuration to enhance the task areas in this section including creation of templates, configuration, set up and support of functionality of SharePoint as related to the out of the box features available for use, work flows, reports, and other business office type functions.

Database Administration Facilitation Services The Contractor shall facilitate technical discussions on database administration requirements for software releases and infrastructure upgrades. The Contractors shall work with Project Managers to review plans for individual test and release plans. The objectives of this task area are:

1. Improve timeliness and availability of data and information

1. Improve quality of information to reduce time in decision making

1. Free up time from data gathering & analysis to value-add analysis

1. Create a shared behavior with metrics to ascertain progress and process improvements

1. Connect the dots between different IT groups, the business and data stewards/governance groups

1. Determine proper resource loads within a scalable repeatable and sustainable process.

The Contractor shall perform the following activities:

· Facilitate the inclusion of database architecture information for the release management process with the project team and FDA environment controls

· Provide guidance and prepare requests for change (RFCs) associated with database architecture upgrades and releases

· Provide guidance and prepare versions of the Architecture and Implementation Configuration Request (ACR) and the Target State Diagram (TSD)

· Facilitate/coordinate and track data management, data modeling and control activities associated with a system release or infrastructure upgrade.

Security The contractor shall provide input into security planning, including the assessment of security risks, preparing responses to security related data calls (e.g. Privacy Act responses) and supporting Certification and Accreditation activities, including tracking Plan of Action and Milestone tracking (PO&AM). While not a resource intensive activity, adequate support requires expertise in security standards and regulations, the specific applicability at FDA is the Office of Management and Budget (OMB) Circular A-130, Appendix III, Security of Federal Automated Information Resources, and the FDA Certification and Accreditation Program that applies to all FDA IT application systems. The Contractor shall review security related EPLC artifacts such as:

· Systems Security Plan

· Contingency and Disaster Recovery Plan

Meetings The contractor shall participate in meetings as summarized below. As required, the contractor shall prepare the following: meeting agenda, minutes or notes, issues and action items. Additionally, the contractor may be required to distribute the related documentation (generally by email), and actively contribute to the meetings. On average, support staff can expect to attend 2-4 meetings per week for each task, though these are only estimates.

The contractor shall convene and participate in the following meetings:

· Task Order Kickoff Meeting - Contractor will coordinate this meeting within 10 working days of contract award. Purpose of this meeting is to introduce contractor staff to the government staff that will be managing the task order. This meeting will include expectations for future work and follow-on meetings to report on task order costs, burn rates, schedule, and any factors that may affect the task order.

· Status Update Meetings – Contractor shall coordinate, at a minimum, monthly meetings with responsible government staff (Task Order COR, and if necessary, IDIQ COR and/or CO) for reporting the status of the task order. During these meetings, Contractor shall report on costs, burn rates, scheduling and any other factors that may affect the task order.

· For all the above meetings the Contractor shall prepare the following: agenda, minutes or notes, issues and action items, distributing related documentation, and actively contributing to the meeting to meet its goal. On average, Contractor staff can expect to attend 2-4 meetings per week.

Briefings The Contractor shall prepare and participate in briefings. Briefings are short, high level, and primarily focused on transmission of specific technical information or management related information. The Contractor will integrate information from other related activities into focus and develop meaningful briefing materials that aids in Government decision making.

Responding to Data Calls The contractor shall respond to data calls that may originate from FDA, HHS, OMB, GAO and others. There are approximately 50 data calls in a 3-year period of varying complexity, from one-page answers to a single question to 25+ page complex spreadsheets. Calls for information typically include:

· FDA mission needs and their relationship to system functionality

· Status of planned or existing projects or systems

· Platforms/tools/technologies of existing or planned projects or systems

· Budgets/schedule/risks associated with planned projects of systems

Responses shall be vetted through the task order COR prior to response, unless otherwise provided written direction by the COR.

Quality Assurance The Contractor shall provide Subject Matter Expertise to support FDA’s Quality Assurance activities for the three ORA investments and their associated projects and systems. The Government performs surveillance to determine whether the contractor exceeds, meets or does not meet the standards. If the Contractor does not meet a task order performance standard, the Government will inform the Contractor. The Contractor shall perform the following activities:

· Review and analyze performance standards that support Quality Assurance activities.

· Review and provide feedback regarding project/program development, implementation plans, and schedules to ensure they adhere to EPLC guidelines or that the standards processes have been appropriately tailored to the needs of the specific project.

· Participate in EPLC stage gates reviews at the end of each development cycle to ensure that industry best practices have been followed, to assure correctness and completeness of EPLC required deliverables.

· Provide input for developing appropriate QA plans, establishing metrics, and providing critical analysis of EPLC-related artifacts as required by the FDA management teams. Typical QA EPLC deliverables are as follow:

· Version Description Document (VDD)

· Test Cases Specifications

· Requirements Traceability Matrix (RTM)

· Review ,analyze and provide recommendations to the FDA on implementation plans for software releases, infrastructure upgrades and enhancement capabilities

· Review software contract EPLC artifacts for alignment to FDA standards and provide recommendations to the Government for improvements

· Review Stage Gate documents, and provide recommendations to the Government

· Review and analyze performance testing strategy and analysis and documentation of execution results

· Perform ongoing review and modification of EPLC standards and best practices

· Provide review and analysis of system requirements artifacts

· Review program/project security plans and provide feedback and recommendations on identified security risks

· Review and/or recommend improvements to internal procedures and processes that could improve the quality, efficiency and effectiveness of FDA’s IT software projects

· Participate in FDA working groups as subject matter expert

· Provide recommendations for modifications of the FDA’s Investment Life Cycle (general system development modifications or suggested modifications for adapting the lifecycle to infrastructure projects)

· Update of program/project document repository and intranet/internet with approved recommendations, reviews, and updated documentation

· Perform complex analysis and reporting, utilizing data within and external to the program repository to support business planning activities

· Provide recommendations for modify current processes and templates for infrastructure projects

· Provide review and analysis of Quality Control Plan

Test Management The Contractor shall provide test management oversight services and review of quality control activities associated with ORA’s investment projects. The Contractor shall perform the following activities:

· Provide reviews and analysis of plans and strategy for requirements, system, unit, Section 508 compliance, security, UAT testing and applicable EPLC artifacts.

· Provide review and input for test cases and business scenarios for projects, as requested

· Review and provide input for project test plans and applicable EPLC documentation

· Track, monitor and manage testing related issues, processes, change requests, prioritization of changes, and briefings.

· Analyze and provide feedback related to test results, test issue resolution, risks, mitigation and analysis.

· Analyze and make recommendations to refine the requirements, system, test plan, processes or documentation

· Plan and execute independent business process testing to support releases of FDA applications at the end of each EPLC phase. This work is performed in parallel with development system testing. In addition, the contractor shall provide development and test teams with performance test script creation, execution

· Perform performance test execution and results analysis and summarize them in a management level report to support the Implementation Stage Gate review and the resulting management decisions.

· Assist in acceptance testing upon request, by documenting issues and tracking issues until resolutions are provided

· Facilitate and coordinate activities required to make sure that FDA dev/test/preprod/prod environment is ready for regression and performance testing to support regression and performance testing on ORA’s applications prior to release into the production environment by analyzing corresponding TSDs (Target State Diagrams).

· Review, maintain and execute test scripts to test application software prior to release. All results will be documented how and included as part of the input to Implementation Readiness Reviews. The contractor shall do all the testing related work per FDA required Standards (see Standards Section 4.6).

Task Order Management and Control A plan shall be submitted in accordance with the requirements of Attachment C,section 5 of the base contract’s statement of work (SOW).

Deliverables and Milestones Deliverables and schedule shall be coordinated by the FDA IPS ORA COR. Standard templates for reports/recommendations, and other documents, shall be provided as needed.

1. Work assignment of the contractor will be done per the IT Governance requirements (http://www.hhs.gov/ocio), including FDA tailored EPLC (http://sharepoint.fda.gov/orgs/DelMgmtSupport/IntakeProc/EPLCv2/SitePages/v2/eplcHome.aspx) and the direction of COR.

2. The Contractor shall provide the following, as a result of specific tasking in performance of the activities in Sections 4 and 5 above:

The Contractor shall provide FDA copies of its work papers, organized and easily accessible. Through each Phase of work, the Contractor shall work with Agency personnel to ensure that appropriate knowledge transfer occurs with key Agency personnel. All documentation/artifacts delivered to the FDA shall be provided in a format specified and approved by the COR.

The Contractor shall submit all preliminary, intermediate and final task order deliverables in electronic formats to the FDA. For automated formats, the following software packages shall be used:

· Reports – Microsoft Word 2003 or 2010

· Spreadsheet – Microsoft Excel 2003 or 2010

· Project Schedules – Microsoft Project 2003 or 2010

· Presentations – Microsoft PowerPoint 2003 or 2010 If not possible to include graphics and images (for example for figures and illustrations) in the same electronic file, FDA will accept text in one of the above formats and the graphics and images as separate files. Acceptable graphic and image files formats are:

· jpg

· tif

· bmp

· vsd All deliverables as defined by this Statement of Work shall be provided to the COR and any authorized personnel of COR in draft electronic form for FDA’s review and comment.

Reports shall be sent to the following addresses as specified:

Contracting Officer’s Representative (COR)

One (1) Electronic Copy via email and/or CD One (1) Original Hardcopy

Key Personnel All contractor personnel supporting this Task Order shall sign non-disclosure agreement, FDA Form 3398: Contractor’s Commitment to Protect Non-Public Information (NPI) Agreement and provide the signed agreement to the Task Order COR. All subject matter expert(s) and the project manager supporting this order are considered “Key Personnel” pursuant to HHSAR clause 352.242-70.

Period of Performance The duration of this order shall be twelve (12) months from date of task order award.

Place of Performance The place of performance is defined as the Government’s facility located in North Bethesda, MD.

Government Furnished Equipment (GFE)

The FDA will provide the contractor with computers and access to general office equipment during performance of this order. GFE shall only be used expressly to satisfy the requirements of this order. A GFE addenda accounting for equipment by serial and FDA property tag ID shall be incorporated into this task order following award.