Accelerating an organization’s ability to bring compliant products to market.

LEARN ABOUT THE BENEFITS OF A MANAGED SERVICES MODEL

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The following functional areas are well suited for a managed services approach where a provider can take over the entire function and implement best practices.

COMPUTER SYSTEMS VALIDATION (CSV)

While a highly specialized and essential area, CSV is paramount for regulatory compliance, and these activities should not be treated lightly. It is a capability that all life sciences companies must perform consistently and accurately.

CSV is a multi-faceted function covering a wide range of validated computer systems across the entire business. At any point it can span the research, clinical testing, manufacturing and distribution process. It is especially complicated with the influx of cloud-based computer systems along with the traditional on-premise systems. This added complexity is why most organizations would benefit from wrapping their quality and compliance functions into a managed services engagement, from vendor auditing through computer system validation testing.

Client Value

  • Ensure consistent and compliant CSV with expert insight and services, from custom implementations to agile project and audit management
  • Transform your review and approval process with the strategic implementation of industry-leading tools, plus expert training and ongoing maintenance
  • Implement best-in-class processes that allow you to have the confidence in the accuracy, reliability and consistency all while ensuring data integrity is maintained

COMMISSIONING, QUALIFICATION AND VALIDATION (CQV)

Ensuring that manufacturing facilities, equipment and utilities are commissioned and qualified, and that processes are validated, is critical for success in the life sciences industry. In addition to optimizing the cost of ownership and maintaining your manufacturing systems in a validated state, a managed service approach provides continuous improvements to ensure assets are optimized and running as effectively and efficiently as possible. It also actively supports operations so emphasis can be placed on customers and business needs.

Client Value

  • Ensure equipment, facilities and processes are maintained in a validated state utilizing the latest technologies and proven delivery strategies from up-front project planning through process validation
  • Employ diverse and flexible technical expertise and cost-effective staffing strategies and software tools (such as paperless validation) to deliver projects on schedule and on budget to accelerate speed to market
  • Implement continuous improvements that result in improved system reliability, increased efficiency and cost reductions

INFORMATION MANAGEMENT AND ANALYTICS (IMA)

All organizations must deal with a variety of data from applications, third party vendors and government agencies. Managing this information in a highly regulated industry can
be difficult and time consuming, as well as risky. Regulatory bodies require data integrity throughout the product lifecycle to ensure that products are safe. Many organizations do not have the time, resources or skills to do this effectively.

Managing data and analytics involves organizing, labeling and structuring information from disparate sources while following guidelines such as ALCOA+, GDPR and the Sunshine Act. While this area can be complex, it is very well defined and repeatable under a solid data architecture. With hundreds, if not thousands, of integration and consolidation programs, this can be overwhelming for IT departments. Most of the activities such as meta data and data integration can be performed via a managed services provider.

Client Value

  • Offload mundane, repeatable and known activities such as data wrangling, test and training model preparation, model tuning and optimization so your data scientist can do more and experience better job satisfaction
  • Draw actionable insights from raw data via advanced analytics and best practice steps
  • Employ critical thinking experts who ask the right questions to meet key success metrics in the analytics-related field

It is entirely possible to outsource specific functions that make the most sense to either one MSP or multiple depending on your relationship and preferences. This does not relieve the company from its compliance obligations, so the final approval is always up to an internal team member.

These areas merely scratch the surface of where and how and MSP can support your organization so you can focus on your core business – bringing compliant products to market.