Rethink Your Validation Approach to Drive Innovation

Consider the benefits of outsourcing validation and qualification to address the system lifecycle from planning and implementation to retirement.

Meeting validation requirements ensures that your life sciences organization achieves regulatory compliance and helps maintain product quality and safety. Responsibilities are often distributed among internal teams and third-party vendors, but your organization is held accountable when audits and inspections occur.

When you manage your in-house validation team, you must invest significantly in tools, systems, and continuous updates. You also have the long-term challenge of balancing scope, cost, and quality. Retaining experienced validation professionals can be difficult in a competitive market, and the invaluable tacit knowledge that is lost with their departure is unthinkable.

Herein lie the benefits of transitioning from in-house validation to an outsourced integrated GxP compliance approach. USDM Life Sciences is on the cutting edge of technological innovation and compliance. We simplify your ability to meet regulations, optimize and automate your GxP processes, and maximize the ROI of your technology. For cloud or on-premises, we enable continuous GxP compliance and use proactive measures to develop, validate, and oversee your products, services, and projects.

Unlock Substantial Cost Savings by Outsourcing Validation

Managing validation internally often leads to resource strain and unpredictable costs. By outsourcing validation and leveraging USDM’s integrated GxP compliance services, organizations can achieve:

• Significant Savings: Reduce the cost of maintaining in-house validation resources and tools with USDM’s outcome-based service level agreements.
• Access to Expertise: Gain insights from domain experts proficient in Computer System Validation (CSV) and Computer Software Assurance (CSA), ensuring the latest best practices are applied.
• Enhanced Compliance: Minimize risks with a robust, consistent validation framework tailored to your needs. 

Learn how to achieve remarkable cost savings with integrated GxP compliance—get the white paper.

Enhance Productivity with Built-In Automation

As life sciences companies increasingly adopt SaaS and cloud technologies, the need for efficient and compliant release management grows. USDM delivers:

• Cloud Assurance: Enable seamless validation for frequent software updates, ensuring systems remain compliant without disrupting operations.
• Automated Testing: Simplify and expedite testing processes while ensuring compliance with 21 CFR Part 11 and global regulatory standards.
• Integrated Tools: Utilize the Application Lifecycle Management (ALM) and Validation Lifecycle Management (VLM) capabilities of ProcessX to align validation activities, change control,  and GxP System Inventory.

Achieve Scalable Validation Across Your Organization

USDM supports both on-premises and cloud-based systems, harmonizing validation processes to align with business goals. Our holistic approach integrates people, processes, and technology for scalable and transformative results.

• Faster Implementation: Implement validated solutions quickly, minimizing downtime.
• Increased ROI: Maximize the value of IT investments by integrating validation with GxP workflow automation, maximizing system functionality, and reducing the need for paper-based processes.
• Global Compliance Alignment: Simplify navigation of complex regulatory landscapes with expert guidance.

Success Stories: Driving Innovation Through Modern Validation

USDM’s expertise has delivered measurable outcomes for organizations across the life sciences spectrum:

• Biotech Efficiency: A biotech firm streamlined a manual document approval process with an eSignature platform validated by USDM, boosting remote workforce productivity.
• Digital Transformation: A Fortune 500 medical device company replaced paper-based processes with GxP-compliant electronic records, improving data accessibility and decision-making.
• AI-Powered Compliance: A global pharmaceutical firm deployed a validated AI framework for Microsoft Azure, scaling chatbot solutions to support clinical trials effectively.
• Process Optimization: A clinical-stage oncology company implemented scalable workflows to meet evolving regulatory needs and drive operational efficiency.

We want to help you, too! Let’s discuss a holistic approach to your people, processes, and technology to help harmonize compliance across your organization and create measurable efficiencies.