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Discover a next-generation business model that drives tangible business outcomes

Discover a next-generation business model that drives tangible business outcomes

Find out why the value of managed services outweighs the cost. Propel your life sciences company into an era of optimization and transformation with integrated GxP compliance.

Managed services are a go-to option for offloading validation tasks for regulatory compliance and freeing internal teams to concentrate on mission-critical, value-added projects.

Now, next-generation business models go beyond delivering services to provide tangible business outcomes and value. Also known as outcome-based or as-a-service models, next-generation business models empower Quality teams to be proactive in minimizing risk and ensuring regulatory compliance.

Dig into a validation cost comparison to see how much you can save by having  
GxP compliant software solutions in place—download the white paper

Changing the Way Businesses Operate

Next-generation business models incorporate cutting-edge technologies and innovative approaches to deliver tangible business outcomes—results you can quantify and measure—like revenue, profit, time savings, and how much value-added work your employees can accomplish.

USDM Life Sciences employs a holistic GxP managed service approach to integrated GxP compliance that accelerates optimization and transformation for pharma, biotech, and medical device companies. The framework is built on two pillars: defining value and measuring value.

Defining Value: Delivering Solutions for Innovation

In the arena of managed services, value must align with a company’s strategic objectives. Compliance, operational efficiency, and innovation should work together to propel the company’s growth trajectory. This can be accomplished by facilitating:

  • Business outcomes: Value must be linked to specific business outcomes like expediting time-to-market for products, increasing operational agility, mitigating compliance risks, and maximizing customer satisfaction. 
  • Risk mitigation: Setbacks like compliance-related risks and data breaches could tarnish a company’s reputation or financial standing. USDM’s Integrated GxP Compliance approach plays an active role in mitigating these risks. 
  • Innovation enablement: Integrated GxP compliance nurtures innovation by enabling your teams to concentrate on strategic initiatives and employ automation, process refinement, and advanced technologies. 
  • Collaborative partnership: Value creation thrives in the symbiotic relationship between the managed service provider and the customer. USDM is a strategic partner equipped to offer insights, expertise, and tailored solutions that align with the customer’s objectives.

Measuring Value: Identifying Metrics for Success

Cost efficiency isn’t the sole focus of the next-generation business model—business outcomes matter, too.

  • Time-to-market: Accelerated product development and a commercialization timeline are hallmarks of success. Time-to-market accelerated by our integrated GxP compliance approach helps companies gain a competitive edge. 
  • Compliance adherence: Consistently meeting compliance standards is a crucial barometer for the value of managed services. It’s evaluated through regulatory audit success rates, conformity with industry benchmarks, and timely compliance procedure updates. 
  • Customer satisfaction: The influence of integrated GxP compliance on customer contentment is evaluated by the quality and reliability of products and services delivered to customers. 
  • Continuous improvement: The velocity of continuous improvement spurred by the managed service provider is quantified by sustained value creation.

Download Integrated GxP Compliance for the Life Sciences Industry 
to learn more about defining and measuring value.

Applying automation for efficiency and compliance

Automation plays a pivotal role in maintaining compliance across a spectrum of Software-as-a-Service (SaaS) applications. Automated and ongoing software testing helps ensure that regulated systems remain in a state of compliance no matter how frequently vendors release updates, changes, and patches. Additionally, automation streamlines compliance management processes and monitors application changes and vulnerabilities. For example, digital teams are able to use automation to assess risk, enforce system policies, and document changes to the system.

USDM Cloud Assurance and ProcessX automates testing activities

To simplify release management, perform tests consistently, and support full-suite regression testing, Cloud Assurance automation tools are configured to control the installation, configuration, management, and testing of cloud computing systems. Automated and ongoing software testing helps ensure that regulated systems remain in a state of compliance no matter how frequently vendors release updates, changes, and patches.

A proprietary solution, ProcessX is an intelligent GxP process automation application hosted on ServiceNow. ProcessX provides the platform for a single source of truth so you can generate your controlled system inventory on demand and directly from ProcessX to provide to an auditor. 

Enveloped in integrated GxP compliance, automation enables your teams to concentrate on strategic initiatives and nurture innovation.

Achieving Continuous Improvement and Sustainable Transformation

Continuous improvement is a significant contributor to USDM Integrated GxP Compliance and sustainable transformation. It’s a result of implementing new ideas, technologies, and best practices to optimize core business functions, mitigate risk, and enhance efficiency in an organization.

The concept of integrated GxP compliance acts as a catalyst for innovation, adaptability, and continuous improvement while maintaining compliance for regulated cloud applications. This approach empowers businesses to perpetuate continuous improvements while adhering to stringent regulatory requirements.

Conclusion: Using a next-generation business model to create value

Next-generation business models take you to the next level of value. They turn insights into action to help bridge skills gaps with outside expertise, operate with greater agility, and gain a competitive advantage.

Learn why integrated GxP compliance is the next-generation business model that will empower your organization with cutting-edge technology, risk mitigation and management, and scalability that matches skill sets to your business needs. Contact USDM today.

Navigate the landscape of in-house validation and outsourcing. 
Download the Integrated GxP Compliance white paper to get started.


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