OperationIT

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Life Sciences

Life Sciences

OperationIT’s technology contribution to the Life Sciences Industry enable you to gain control of costs, drive compliance, improve and automate customer service, satisfy process management needs, and streamline the way you enter, access, and share secure data. Life science companies are challenged with driving new products to increase revenue and growth while improving innovation and preparing for new regulatory challenges in a global business environment. Meeting these challenges demands transformation that will change the way healthcare is dispensed. To enable this transformation, life sciences companies must institutionalize compliance across core processes, embrace operational excellence from the supplier to the customer, and innovate with partners worldwide to accelerate new product and process development.

Adherence to data validation, security and process integrity requirements mandated by the FDA, including 21 CFR Part 11, have been the cornerstone of OperationIT’s Life Sciences Service offerings.

OperationIT provides complete business software solutions for Life Sciences companies requiring FDA cGMP compliance. With OperationIT’s consulting solutions companies adhere to the stringent data validation, security and process integrity requirements mandated by the FDA while leveraging the power of systems as SAP’s Life Sciences solutions, Oracle’s Life Sciences platform and solutions, Microsoft’s integrated business systems, and SAS and other Clinical Trial Management software. OperationIT’s talented personnel provide expertise covering the entire life cycle of a pharmaceutical or biotechnology product. The complete cycle includes Manufacturing Execution Solutions (MES) — spanning the phases of the life cycle from Research & Development (RDM) and Clinical Trial Management (CTM) through production utilizing Integrated Architecture Solutions. OperationIT’s expertise In this industry also encompasses complete, enterprise-wide solutions, including:


  1. Part 11 Audit Trails
  2. Quality Management
  3. Adverse Event Reporting
  4. Batch and Lot Records Management
  5. Product Life-Cycle Management
  6. Vendor Management
  7. Sales & Distribution Management
  8. Supply Chain Management, including Transportation & Logistics
  9. Financial Management
  10. Customer Sales Order Management
  11. Relationship Management
  12. Customer Service Management
  13. Project Management

OperationIT’s compliance personnel render support for 21 CFR Part 11 Compliance. Their Audit Trails enables compliance with FDA 21 CFR Part 11 regulations. They provide audit trail tracking and reporting in all areas of their ERP system which are FDA significant, including batch records, engineering changes, quality records, inventory status transactions, process instructions and recording of results.