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Managed Services

USDM provides services to allow life sciences companies to outsource traditional Quality functions. USDM can manage key aspects of your quality system. These include performing all supplier and internal audits, managing supplier qualification process, managing CAPA system and exception management, change control, etc. USDM can manage your complete validation systems to include all system procedures, life cycle, validation planning, risk assessments, and specific validation of equipment, computer systems, and processes. USDM’s Managed Services is a blended onsite/onshore/offshore model for managed services (development and support). It incorporates the lessons learned from traditional offshoring or outsourcing. 

Traditional Offshore Challenges

  • Challenge 1: Teams not familiar with computer system validation (CSV) methodology. SolutionUSDM Life Sciences uses CSV experts and incorporates customer specific training. The life sciences industry is all that we do.

  • Challenge 2: Cultural differences mean teams don’t always understand the business process and test objectives. No overlap in working hours mean you could lose a full day. SolutionUSDM utilizes onshore team for test development.

  • Challenge 3: Team is not always dedicated causing loss of process knowledge and time delays. Solution: USDM provides dedicated team of onsite and onshore resources that will manage each system.
  • Challenge 4: Visibility to system performance. SolutionUSDM provides detailed summaries and metrics for client oversight. These are designed to fit into the client’s quality system and management review. 
  • Challenge 5: Demonstrating seamless integration into the client’s quality system. SolutionUSDM will provide a plan, risk assessment, and system structure to show the outsourced activity is fully integrated and compliant. 


There are three offerings available:

  • Compliance as a ServiceUSDM Life Sciences will manage any element of your quality system. Think: Internal Audits, inspection management, supplier audits, supplier qualification, investigations, CAPA, Change control, risk management and data integrity). This allow companies to be more flexible with growth and large fluctuations in volume. This will free up your team to be focused on key quality and business objectives. 

  • Support On DemandUSDM Life Sciences can support your regulated global application, ensuring you stay up and online as well as in compliance.

  • Development On DemandUSDM Life Sciences' developers are fluent in the life science domain and business process. Use USDM’s Development On Demand to handle changes to your validated system.

Contact us today to arrange a meeting to learn more about this exciting service. 

Testimonials

  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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