42 Background and Introduction: The Food and Drug Administration (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 helping the public get the accurate, science-based information they need to use medicines and foods maintain and to improve their health. As per FDA regulations an official system of records is required for most regulated human drug and therapeutic biologic products marketed in the US. Such a system contains proprietary business data, personal data covered by the Privacy Act of 1974 and the Freedom of Information Act (FOIA), and medical data covered by Health Insurance Portability and Accountability Act (HIPAA) and FOIA. These "Software" systems which ensure compliance with FDA regulations are referred to as Drug Safety System, Pharmacovigilance system or Safety Surveillance System. FDA regulations require manufacturers to submit reports; consumers and health care professionals submit reports voluntarily. Submitted data is reviewed and evaluated by clinical reviewers at FDA to detect safety signals and to monitor product safety. They form the basis for further epidemiological investigational studies when appropriate. As a result of these evaluations, the FDA may take regulatory actions to improve product safety and protect the public health. MultiVigilance provides project management and business-functional expertise in the implementation of software systems and processes for safety and pharmacovigilance, regulatory information management, regulatory compliance and validation to pharmaceutical and biotech companies. MultiVigilance services include - 1. Implementation of Drug Safety Software solution a. Requirements Elaboration and business, data and systems analysis b. Program Management c. Validation 2. Application Management Services 3. Signal Management, Data Analytics 1a. Requirements Elaboration and business, data and systems analysis Multivigilance team of expert provide advisory services in the areas of: 1. Translate user needs into business requirements. Ensure requirements are tested and provide expected functionality 2. Participate in user interviews, document analysis, requirements workshops, storyboards, surveys, business process descriptions, use cases, scenarios, business analysis, tasks and workflow analysis. 3. Define quality attributes, external interfaces, constraints and other non-functional requirements. 4. Represent requirements using alternative views, such as analysis models (diagrams, prototypes, or scenarios. 5. Elicit and document feedback from validation sessions and produce use cases identified as gaps. 6. Manage requirements traceability information and track requirements status throughout the project. 7. Manage changes to baseline requirements through effective application of change control processes and tools. 8. Conduct independent verification and validation of existing requirements. 1b. Program Management MultiVigilance team brings a strong services background with focus on implementation and upgrade of drug safety and regulatory solutions to achieve objectives and establish project plans, structures, processes, schedules, reporting requirements, communication channels and quality control functions necessary to successfully execute the delivery, configuration, implementation, and maintenance of the pharmacovigilance software. Program management services covers: 1. Monthly Status reporting and quarterly steering committee reporting 2. Establish communication protocol and define escalation procedure 3. Quality Management using proper quality assurance methods related to document control, records or information activities 4. Manage project risks to schedule, cost and quality and provide risk management strategies 5. Change management to establish an orderly and effective procedure for tracking the submission, coordination, review, evaluation, categorization, and approval of all changes to the project's baselines. 6. Release management to support the development and deployment of system releases to the appropriate environments. 7. Draft project supporting documentation such Project charter, work breakdown structure, Risk management plan and risk tracking log, system requirements specification, system design document, test planning and reporting, Training plan, user manual etc. 1c. Validation MultiVigilance provides full range of validation services and coordinate, lead and execute the user acceptance testing efforts. Validation services includes: 1. Plan activities to ensure alignment between UAT approach and other elements of the implementation such as implementation approaches, business needs, user requirements, informatics transitions and evolving user roles 2. Draft Validation plan and strategy 3. Draft Installation Qualification, Operational Qualification and Production Qualification scripts 4. Draft Test scripts that effectively translate project use cases into test scripts 5. Lead and facilitate overall execution of the validation plan and user testing 6. Identify, report and record validation failures 7. Verify and analyze validation results 8. Produce validation summary report 2. Application Management Services MCL team will provide various IT operations and maintenance support tasks as well as development of additional requirements / enhancements that have not yet been delivered. Application management services includes: 1. Maintenance releases and Operations and Maintenance Change Requests 2. Integration Support, Technology upgrades and New Mandates 3. Software Transition and Close out 4. Help Desk activities such as assist users with any complex database searches, tune and optimize system performance, update and insert changes to dictionaries and reference data, modify reference data or business rules, investigate defects reported by users, investigate changes to the system to implement requested changes to requirements, prepare corrections to data value changes to dictionary, update architecture documents, design documents, database schema, training manual and other essential documents 5. Data Refresh activities 6. MedDRA upgrade activities 7. Deliver software to correct defects in Emergency Releases. 8. Data Extract activities 3. Signal Management, Data Analytics Data analytics ad Signal management is performed on Drug Safety Adverse Event Dataset which is stored in a Drug Safety Data Warehouse. MCL team will provide drug safety signal management and data analytics services which includes 1. Data mining, data discovery and signal management (identifying, analyzing and documenting signals). 2. Reconcile Safety data across sources 3. Configure role-based dashboards 4. Develop and maintain out of the box software data reports, customized and adhoc reports 5. Signal assessment reports for specific product-event pair 6. Case report comparisons 7. Data extraction, transformation and load on to data warehouse 8. Integrate with most common data warehouse (e.g. HANA, Hadoop, Business Objects etc.)
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