FDA Sources Sought: Empirica Signal Support Operational & Maintenance

Notice ID

FDA-SS-75F40124Q00067

Task Area 1 – Program Management

The Contractor shall perform program management activities for the overall contract down to the sub­ Task level that are necessary to support the execution of its approach to the management and technical aspects of this contract. The Contractor shall adhere to and comply with the FDA’s Enterprise Performance Lifecycle (EPLC) management process.

Task Area 2 – Project Management

The Contractor shall provide project management to establish control, management, monitoring and notification mechanisms, ensuring that contracted tasks stay on track and important milestones and performance measures are met. The Contractor shall prepare a Management Plan describing the technical approach, organizational resources, risk management and other management controls to be employed to meet the cost, performance and schedule requirements throughout execution.

•             Representative activities include:

o             Status and progress of tasks

o             Schedule Management

o             Cost Management

o             Earned Value Management

Prepare and manage to a Risk Management Plan which clearly documents the Contractor’s risk management approach to address risk identification, tracking, communications, and analysis, prioritization, and mitigation strategies

•             Progress against service level agreements

•             Establishing and tracking metrics and SLAs including but not limited to:

o             Defects

o             Availability rate

o             Issue resolution

o             Issue escalation

o              Customization/enhancement

o             Testing progress and results

o             Staffing

o             Communication

Quality Management to include developing a Quality Assurance Plan detailing the specific methodologies, performance measures and metrics, management tools and quality control measures to be used to ensure contract services meet CTPs service level agreements.

•             Develop and submit Request Quality Services and Technology (RQST-IT) requests and tracking them from inception through completion

•             Formal and Informal Meetings- Conduct or participate in meetings to include preparing and tracking meeting agendas, minutes, issues, risks, and action items

•             Monthly and Weekly Reporting

Task Area 3 – Transition activities

If applicable, transition activities take place to efficiently transition all activities to the new Contractor. As tasked, the Contractor shall develop transition–in and transition-out plans and conduct transition activities.

Task Area 4 – System Configuration, Customization, Testing and Deployment Support

Deliverable products shall be validated and tested to ensure that they meet applicable/specified standards, policy, business requirements and quality measures. The FDA works within an Integrated Project Team that will assist in identifying testers and facilitate overall testing engagements. However, as tasked, the Contractor shall support FDA testing processes by ensuring proper configuration, tracking bugs or change requests, versioning and other activities to assist in a successful testing cycle of the product.  Typically, the product is tested as frequently as appropriate to ensure timely implementation of an agreed upon release scope…