USDM delivers a transformative service that expertly manages GxP compliance for Oracle Cloud customers

USDM Life Sciences and Oracle have partnered for more than 15 years to provide world-class solutions that enable life science companies to meet FDA 21 CFR Part 11 and EMA EudraLex Volume 4 Annex 11 regulatory requirements.

USDM’s Cloud Assurance is a managed service where USDM handles the entire compliance workload from risk assessment to validation to continuous compliance and maintenance. Using automated testing tools, USDM provides Oracle Cloud customers an efficient and cost-effective way to achieve and sustain compliance. 
 

USDM Cloud Assurance + Oracle Customer Benefit 

  • Enable the move to Oracle SCM for life science customers 
  • Ensure your entire SCM and product data management systems are continuously compliant 
  • Decrease the cost to manage compliance  
  • Significantly reduce adoption, implementation, and validation time 
  • Harmonize and centralize control 
  • Maintain continuous cloud compliance  
  • Manage every new release 
  • Enable a platform of complaint technology solutions  
  • Optimize business operations with Workflow-as-a-Service  


Addtional information:


FAQ

What is USDM Cloud Assurance for Oracle?

Is existing on-premise and new Oracle customers move their regulated data to the cloud, USDM Cloud Assurance provides a solution to enable these customers to achieve and maintain continuous compliance in a cost-effective and efficient manner. USDM Cloud Assurance provides a managed subscription service that enables Oracle Cloud customers to productively validate their implementation and maintain the system compliance with Oracle updates.


USDM Cloud Assurance also allows life science organizations to take advantage of all the benefits and innovations of Oracle Cloud. With every new product release, USDM Cloud Assurance ensures continuous compliance for FDA and EMA regulations of Oracle Cloud solutions. As Oracle’s Cloud solutions evolve through ongoing development and new functionality, customers can immediately take advantage of the new functionality while staying compliant. USDM’s automated regression suite provides the ability to verify, overnight, that your Oracle Cloud system is still compliant after Oracle releases system-wide updates. USDM Cloud Assurance further provides ready-made templates of key Software Development Lifecycle (SDLC) validation deliverables to assure your company quickly goes live and stays in a compliant state.

Why do I need USDM? Can’t I implement Oracle myself?

Oracle releases new updates on a quarterly basis. USDM has access to these new releases in advance and works directly with Oracle product management to ensure that required validation content, and activities are updated to keep Oracle customers compliant. Without USDM, life science companies have less time for testing and validation and have more required resources and costs to maintain compliance. USDM’s subscription services takes the burden of compliance off the customer, allowing them to focus on running their business.


Oracle and USDM have partnered for more than 15 years to provide solutions to enable life science companies to meet FDA 21 CFR Part 11 and EMA EudraLex Volume 4 Annex 11 regulatory requirements. Since 2004, USDM has developed VAPs for Oracle and has enabled hundreds of Oracle customers to successfully implement and quickly validate Oracle applications. With USDM Cloud Assurance for Oracle Cloud, customers are provided with continuous support of Oracle Cloud releases to maintain compliance.    

USDM and Oracle work together to deliver a comprehensive solution for initial and ongoing validation and compliance maintenance of Oracle Cloud solutions.

What CSV deliverables does USDM provide as part of the Cloud Assurance for Oracle service?

The Cloud Assurance offering provides detailed templates for:
  • System Level Risk Assessment (SLRA)
  • Validation Plan (VP)
  • User Requirements Specification (URS)
  • Functional Requirements Specification (FRS)
  • Functional Level Risk Assessment (FLRA)
  • Configuration Specification (CS)
  • Verification Installation Qualification (IQ)
  • Operational/Performance Qualification test scripts (OPQ) 
  • Traceability Matrix (TM)
  • Release Memo
  • Validation Summary Report (VSR)
  • Administration, Use, and Operations SOP
  • End User SOP
  • Work Instructions for Oracle SCM Cloud (as required per the organization’s CSV SOP)
Does Cloud Assurance include an impact assessment of Oracle quarterly releases, updates, and patches?

As part of the Cloud Assurance for Oracle Cloud service, USDM provides an impact assessment of upcoming releases that includes guidance on the required regression testing based on your organization’s Oracle implementation. The impact assessment is based on your company’s configuration (as provided to USDM).

What else does Cloud Assurance provide for my company? 

Supplemental offerings include POD configuration cloning to save time and money on manually configuring each POD (instance). This feature also allows for the capability to extract and document the configuration for each POD in a report, saving time and money in creating your configuration specifications

How do you maintain compliance for my company’s specific configuration of Oracle Cloud?

USDM provides a customer-specific analysis of Oracle’s releases to ensure all aspects of YOUR unique system configuration is tested according to your inherent risk – within your specific testing environment. Regression test scripts are executed for each release specific to each customer’s configuration. 
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