Operations and Compliance

SAIC is focused on enhancing operational efficiencies, compliance, and uptime within laboratories and manufacturing. Our core competencies include Regulatory Affairs & Quality Compliance; Pharmacovigilance & Risk Management; Integrated Document Management; Knowledge Management; IT Outsourcing; Enterprise Asset Management, Process Automation, and Environmental, Health & Safety Automation.

To provide customers complete solutions, we have relationships with Sensyo, a leading provider of life science enterprise operation management technology, MRO Software, a leading asset management provider, SAS Institute, and Documentum.

As the number one priority for many FORTUNE 500® COOs, shop floor enterprise operations management has come to sit at the heart of every enterprise infrastructure strategy. It is the foundation for time to market, information technology, supply chain and compliance integration, all of which are major return on investment focuses of large, global organizations today. SAIC and Sensyo, a leading French provider of life science enterprise operations management technology have entered into a strategic alliance agreement. The strategic alliance agreement establishes an understanding by both companies to deliver high value integration services in the implementation of Sensyo's SmartAdvance® technology solutions. Sensyo's SmartAdvance® technology combined with SAIC's strong systems integration capability and experience enables us to offer a complete solution to our customers. The customer gains efficient operations that adhere to good manufacturing practices and regulatory guidelines, and are aligned with FDA's Process Analytical Technology (PAT) initiative.

Key Commercial Projects

• Leading Biotechnology Company - SAIC advises and assists with Federal Drug Administration (FDA) compliance issues and subsequent resolution. SAIC provides consulting services for Good Manufacturing Practice (GMP), including compliance audits, validation study reviews, and technical expertise in quality assurance issues. SAIC provides consulting services to perform a mock GMP inspection and written inspection report of the production facilities.
  
  
• Major Global Pharmaceutical Company - SAIC began supporting this customer with the design and development of an environmental information management system (EIMS). The team developed enhanced functionality in the reporting and events management components of this commercially-off-the-shelf EIMS. SAIC has provided experts in environmental compliance, systems integration and software development, and successfully deployed the system for use at three manufacturing sites.
  
  
• Major Pharmaceutical Company - SAIC provided the enterprise system assessment for Maximo® across multiple manufacturing facilities. This involved assisting the client in determining their requirements for specific functions within Maximo, such as, utilization of Workflow tools, definition of like-for-like parts replacement. SAIC also helped define the requirements for integration with other company systems, such as, ERP and document management systems. Also, as part of the implementation and data migration process, SAIC developed and supported validated data loader process for the 'back end' loading of data into Maximo. We also worked with corporate business process managers to develop standards for data collection, which includes new site acquisitions. The implementation also involved the utilization of wireless devices for the field staff, which helped the maintenance staff improve performance and timeliness of processing work orders.
  
  

Key Government Projects

• National Institute of Allergy and Infectious Diseases - Our work in Malaria Vaccine Production and Support Services for the National Institute of Allergy and Infectious Diseases (NIAID) involves providing project management, process development, preclinical testing (under Good Laboratory Practices regulations), pilot-scale manufacturing (under current Good Manufacturing Practices regulations), and FDA regulatory submissions to advance malaria vaccine candidates into clinical trials. SAIC creates development plans and awards research subcontracts that are needed to complete individual steps of the plans on schedule and in budget. In addition, we acquire and manage IP necessary for NIAID to be able to test products.
  
  
• National Cancer Institute - As part of our efforts at NCI-Frederick, more than 200 employees maintain over 100 buildings that encompass almost 1.4 million ft2 of laboratory and administrative space. With an annual facilities budget exceeding $22 million, the bulk of our efforts are distributed equally amongst program renovations, breakdown repair, and preventative maintenance, with a smaller and significant commitment to infrastructure repairs. We currently are managing almost $100 million of design and construction projects, and we renovated 34,000 ft2 of space in 2001.