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. It also helps you maintain product quality and safety. Responsibilities are often distributed among internal teams and third-party vendors, but it’s your organization that’s held accountable when audits and inspections come around.

When you manage your own in-house validation team, you need to make significant investments 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 technology and compliance. We simplify your ability to meet regulations, optimize and automate your GxP processes, and maximize the return on investment (ROI) of your technology. Whether for cloud or on-premises, we enable continuous GxP compliance and use proactive measures to develop, validate, and oversee your products, services, and projects.

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

Align Computer System Validation with Best Practices

If you perform your own Software-as-a-Service (SaaS) validation and ongoing maintenance, you may not be getting the ROI for things like functional teams, infrastructure, and testing. This is especially true when more SaaS applications are added to the tech stack and the complexity and velocity of releases intensifies.

By outsourcing the Computer System Validation (CSV) process and ongoing compliance maintenance, you’ll experience benefits like:

• Substantial cost savings. A dedicated service partner with an outcome-based service level agreement (SLA) offers cost-effective expertise that allows your organization to allocate resources to activities that return better value. 
• Greater expertise. Service partners are well-versed in CSV and Computer Software Assurance (CSA), track evolving regulations, and adhere to best practices. Having access to a pool of on-demand domain experts helps to ensure your regulatory compliance. 
• Less risk: A GxP-centric managed service mitigates non-compliance risks, provides a uniform risk-based approach across supported systems, and deflects potential regulatory penalties.

Achieve Unparalleled Compliance with Built-In Automation

Increased dependency on vendors for SaaS and cloud technologies means that organizations must understand how to leverage vendor activities like development, testing, documentation, release management, and support. The CSA guidance from the U.S. Food and Drug Administration (FDA) clearly states their support for leveraging vendor testing and release management in the validation process.

The FDA also encourages the use of new technologies and automation. Automated testing simplifies the testing process while maintaining your regulatory compliance. To simplify release management and equip your organization to be consistent in performing tests, USDM Cloud Assurance automates testing activities and supports full-suite regression testing.

No matter how frequently vendors release updates, changes, and patches, automated and ongoing software testing helps ensure that regulated systems remain in a state of compliance. Save time and practice effective cloud management with automation tools that are configured to control the installation, configuration, management, and testing of cloud computing systems.

Conventional service partners can and do provide automated testing, but having GxP domain expertise is imperative to define, align, and support testing efforts for risk mitigation and continuous compliance. To maximize the ROI for your IT investments and enable transformative outcomes for people, processes, and technology, USDM unites integrated GxP compliance with Cloud Assurance.

To see how it all fits together, download the white paper 
Integrated GxP Compliance for the Life Sciences

Leverage Our Expertise to Manage Your Entire CSV and CSA Processes

The speed of product development presents new challenges to validation, whether on-premises or in the cloud. Simply following your traditional change control processes might make it difficult to keep up with change-impact assessments and identify the right amount of regression testing. Navigating global regulatory requirements is complicated and conducting vendor qualification can be overwhelming.

USDM can help. Remain continuously compliant, optimize and automate your GxP processes, and maximize the ROI of your technology using the USDM Integrated GxP Compliance managed service. We take a holistic approach to your people, processes, and technology, and will help you harmonize compliance across your organization to create a scalable strategy for radical innovation.

Explore Real-World Validation Problems and Solutions

A biotech company replaced a multi-step manual process—printing, signing, and scanning documents—with an eSignature platform solution. They chose USDM to provide a fully validated system that enabled them to comply with 21 CFR Part 11 and improve efficiency in their remote workforce.

A Fortune 500 medical device manufacturer had a very complex, custom approval process throughout the organization. They engaged USDM for digital transformation that extended their Salesforce use from non-GxP to GxP processes. Results include replacing paper-based processes with electronic records and migrating product data from legacy systems to a single platform. 

A global medical technology company struggled to evaluate changes, assess risks, and perform testing before applying quarterly updates to their production environment. They sought the guidance of USDM and were able to refocus on other business needs while USDM managed releases and maintained their validated state.

A global clinical research organization (CRO) with a small in-house quality and validation team needed help to cope with the volume of data generated by their software and were unsure about compliance gaps. A comprehensive solution from USDM enabled the CRO to be compliant, manage software updates, optimize internal resources, and enhance system reliability.

Turning Point, a pre-commercial clinical-stage precision oncology company needed a solution for regulated GxP IT change management and user access provisioning. They chose ProcessX for easy-to-use, out-of-the-box workflows. USDM helped them add four more workflows for scalable GxP and non-GxP workflow solutions that will evolve with the emerging business.

A global pharmaceutical company needed help to create a validated AI framework for Microsoft Azure. USDM built a continuously compliant infrastructure to scale AI chat bot use and helped the customer implement an AI pilot program using Azure Stack and NLP tools. Chatbots were developed for GxP content to support clinical trials.

To see how it all fits together, download the white paper 
Integrated GxP Compliance for the Life Sciences