The objective of this contract is to obtain the necessary resources to perform IT project management, operations and maintenance, development, modernization, and enhancement, and transition support for the QMiS application for the ORA Office of Quality Management System (OQMS) which is responsible for ensuring ORA meets its employees’ needs and complies with applicable standards and requirements.
QMiS has four (4) system modules: 1) Document, 2) Process, 3) Audit, and 4) Training Module. These modules are standard out-of-the-box features within the MasterControl COTS software and have been configured and customized for specific ORA business processes in QMiS. QMiS was deployed in phases by primary functionality: Document Control and Management, Management Review, and Record Control and Management. The system has been upgraded and enhanced with additional functionality including: Corrective Actions, Preventive Actions, Complaints and the Control of Non-Conforming Processes, Products, or Services, Training and Audit capabilities.
The scope of this effort includes the following tasks:
- Project Management Support
- Operations and Maintenance
- Development, Modernization, and Enhancements
- Transition Activities
The Contractor shall provide and perform project management activities for the FDA QMIS contract. These management activities shall establish control and management, monitoring, and notification mechanisms, and shall include working with and reporting to the FDA COR; to ensure that QMIS tasks stay on track and important milestones are met as defined and set by the Integrated Master Schedule…
The Contractor shall perform O&M services for QMIS, and related Modules. The Contractor shall perform ongoing production, test, and development maintenance support which includes O&M Minor Enhancements, O&M Major Enhancements and software upgrades. All tasks shall be performed in accordance with FDA’s Enterprise Performance Life Cycle (EPLC). The Contractor shall update or develop user documentation, system documentation, release notes, and FDA EPLC documentation as necessary to ensure that documentation is current.
In addition to the software maintenance and support delineated above in Section 5.2.1, the Contractor shall provide additional QMiS O&M support to include:
- Software Patch and Release Management
- System Administration
- Help Desk Support…