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Biotech, CMO, CRO, Medical Device, Pharma

Digital Transformation is Critical to Business Continuity

John Petrakis
April 3, 2022

When the COVID-19 pandemic mandated that employees work from home, companies were forced to rethink business workflows and leverage existing technologies, especially cloud-based solutions.

Returning to the office continues to be a challenge as employers follow steps to create a safe and healthy workplace. On top of that, every organization should have a plan to ensure operations and business continuity are not severely impacted by a disaster or significant event.

Digital transformation is essential to enabling access to team resources and ensuring continuous security and compliance. While the life sciences industry has lagged in cloud adoption, the question is no longer, “Should we move to the cloud?” The question is, “How quickly can we move to the cloud?” For those who have made the move, you might be asking, “What now? How do we make the most of this technology throughout the company?”

USDM Life Sciences specializes in helping companies update their roadmaps to identify opportunities or initiatives that will provide the most value. For example, we’ll show you how to leverage your data with cloud-ready tools like advanced analytics and artificial intelligence (AI).

USDM has a community of partners that meets the quality and compliance demands of your regulated business. We have solutions for eSignature, content management systems (CMS), quality management systems (QMS), clinical systems, and supply chain and distribution to establish the foundation for your IT compliance. We’ll also show you how these solutions can work together to ensure seamless workflows among your employees.

USDM User-Ready Cloud Partner Applications

DocuSign eSignature Capabilities – Ready in 10 DAYS

If your employees work remotely and you need to sign regulated documentation electronically, USDM partner DocuSign can ensure you comply with the FDA’s 21 CFR Part 11 regulation. We have perfected this implementation and will have you up and running in just 10 days. USDM has validated more than 100 DocuSign systems using our methodologies, document templates, and processes. There is no need to create your documents from scratch; you will get DocuSign capabilities fully validated for life sciences best practices. System configurations can be modified via change control processes. Rest assured, you will maintain continuous compliance with USDM’s Cloud Assurance.  Contact us today to fast-track your DocuSign implementation.

Box GxP Content Management – Business Continuity + Continuous Compliance
Do you need a cloud-based, GxP-ready content management solution for regulated and non-regulated content? USDM and Box provide an innovative approach for maintaining GxP compliance in the cloud. You can create, collaborate, manage, and distribute information with your remote employees and partners, including contract research organizations (CRO) and contract manufacturing organizations (CMO), all backed by enterprise-grade security and compliance. Let us help you speed up your cloud content management implementation, validation, and adoption.

Salesforce – World-Class Compliant Cloud Platform
The leading customer relationship management (CRM) solution with the most versatile application development platform offers unmatched configurability, scalability, and security. You can easily extend Salesforce to GxP areas like research and development (R&D), laboratories, regulatory, quality, manufacturing, and other regulated areas. USDM offers several rapid implementation services for Salesforce, including:

Implement and customize native applications (sales, service, call center) and complimentary applications (ComplianceQuest, ServiceMax, Rootstock)
Enhance existing implementation to add new functionality (eSignature and Audit Trail) and new processes (clinical, product registration, notice of product change)
Replace legacy applications or paper-based processes, or add a custom business process to an already purchased application
Integration with other solutions using existing connectors (Box, DocuSign)

Read our Salesforce case study to learn how USDM accelerated the digital transformation of a large medical device manufacturer.

ComplianceQuest – The fastest growing, modern cloud Enterprise Quality Management System (EQMS)
ComplianceQuest is a native force.com application suite, built and run on the Salesforce platform, delivering award-winning, globally trusted cloud functionality. With best-in-class out-of-the-box solutions, ComplianceQuest expedites an organization’s efficiency, safety, and overall performance by combining enterprise quality, compliance, collaboration, and communication across the product value chain. Suitable for startups and scalable and flexible enough to meet the needs of large enterprises, ComplianceQuest is easy to implement, validate, and use. USDM helps regulated companies implement ComplianceQuest and integrate it with other critical GxP applications that work together in a single interface to manage quality and compliance requirements in the cloud.

USDM understands the urgency of maintaining business continuity and we are committed to completing your digital transformation quickly and accurately so you can get your products to market faster.

USDM’s Cloud Assurance™ subscription service ensures that all of our partner solutions include GxP compliance from implementation through ongoing validation maintenance—including new software releases—for your cloud applications.

Rapid Cloud Implementation Case Studies

About the Author
John Petrakis, vice president of cloud assurance at USDM Life Sciences, has over 30 years of diverse global industry experience in business transformation, delivering solutions that addresses regulatory and quality pressures, resource constraints, new and growing markets, system integration, and optimization of global operations.