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.
Quick Summary
- Traditional managed services offload validation work; next-generation, outcome-based models go further by delivering measurable business value.
- USDM's integrated GxP compliance framework rests on two pillars: defining value and measuring value.
- Automation keeps regulated SaaS applications in a continuous state of compliance as vendors release updates, changes, and patches.
- Success is quantified through time-to-market, compliance adherence, customer satisfaction, and continuous improvement.
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.
A disciplined approach to validation lifecycle management is what turns this proactive posture into a repeatable operating model rather than a one-time project.
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.
The Two Pillars of Outcome-Based GxP Compliance
- Defining value — Align compliance, operational efficiency, and innovation with strategic business outcomes.
- Measuring value — Quantify results through time-to-market, compliance adherence, customer satisfaction, and continuous improvement.
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.
Compliance-related risks and data breaches can erode reputation and financial standing. Strengthening data integrity across regulated systems is foundational to the risk mitigation an outcome-based model is built to deliver.
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.
Cost efficiency isn’t the sole focus of the next-generation business model—tangible, measurable business outcomes are.
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.
A risk-based, automation-forward approach aligns naturally with Computer Software Assurance (CSA), which focuses validation effort where patient safety and product quality risk is greatest.
USDM Cloud Assurance and ProcessX Automate 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. As organizations extend these models to new technologies, building in AI governance and compliance early keeps innovation moving without compromising regulatory standing.
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.
FAQ: Next-Generation, Outcome-Based GxP Compliance Models
What is a next-generation business model for managed services?
It is an outcome-based or as-a-service model that goes beyond simply delivering services. Instead of just offloading tasks, it is designed to produce tangible, measurable business outcomes—like faster time-to-market, mitigated compliance risk, and greater operational agility—while empowering Quality teams to be proactive.
How is value defined and measured in this model?
The framework rests on two pillars. Defining value aligns compliance, operational efficiency, and innovation with strategic objectives, business outcomes, risk mitigation, and collaborative partnership. Measuring value quantifies success through metrics such as time-to-market, compliance adherence, customer satisfaction, and continuous improvement.
What role does automation play in maintaining compliance?
Automation is pivotal for keeping regulated SaaS applications in a continuous state of compliance. Automated, ongoing software testing helps ensure systems stay compliant no matter how often vendors release updates, changes, and patches, while also streamlining compliance management and monitoring application changes and vulnerabilities.
What are USDM Cloud Assurance and ProcessX?
Cloud Assurance automation tools control the installation, configuration, management, and testing of cloud computing systems to simplify release management and support full-suite regression testing. ProcessX is a proprietary intelligent GxP process automation application hosted on ServiceNow that serves as a single source of truth, letting you generate your controlled system inventory on demand for auditors.
How does this model support continuous improvement?
Integrated GxP compliance acts as a catalyst for innovation, adaptability, and continuous improvement while maintaining compliance for regulated cloud applications. By implementing new ideas, technologies, and best practices, organizations optimize core business functions, mitigate risk, and enhance efficiency—sustaining value creation over time.