USDM delivers a trustworthy service that expertly manages GxP compliance for Oracle Supply Chain Management 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 regulatory requirements.
USDM's Cloud AssuranceTM is a managed service where USDM handles the compliance workload from risk assessment to validation to continuous compliance maintenance for Oracle's SCM Cloud core system. Utilizing traditional Computer System Validation (CSV) or a Computer Software Assurance (CSA) methodologies, along with our automated testing tools, USDM provides Oracle SCM Cloud customers an efficient and cost-effective way to achieve and sustain compliance.
USDM Cloud Assurance Benefits
- Enables the move from on-prem to Oracle SCM Cloud for life science customers
- Maintains continuous GxP compliance by managing Oracle SCM Cloud releases through Cloud Assurance
- Significantly reduces validation time and decreases the cost to manage cloud compliance
- Provides a structured journey map and assessment to identify strategic business initiatives made possible by Oracle
- Scalable technology solutions to grow with your business and establish your compliant IT foundation
- Extensive digital transformation services including people and process changes to drive adoption
Frequently Asked Questions
What is USDM Cloud Assurance for Oracle?
USDM is Oracle's exclusive life sciences compliance partner. As existing on-premises 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 cost-effectively and efficiently. USDM Cloud Assurance provides a managed subscription service that allows Oracle SCM Cloud customers to trust that their system is continuously compliant and maintained with every software update. As Oracle's SCM Cloud solutions evolve through ongoing development and new functionality, customers can take advantage of the new features while staying in a compliant state.
USDM's automated regression suite provides the ability to verify, overnight, that your Oracle SCM Cloud system is still compliant after an Oracle SCM Cloud system-wide release. USDM Cloud Assurance further provides ready-made accelerators of key Software Development Lifecycle (SDLC) validation deliverables to assure your company quickly goes live and stays compliant.
Why do I need USDM? Can't I validate Oracle myself?
Oracle releases new updates quarterly. USDM has access to these new releases in advance and works directly with Oracle product management to ensure that the necessary assessment and tests are in place to keep Oracle SCM Cloud customers compliant. Without USDM, life science companies need more internal resources and have higher costs associated with maintaining compliance on their own. Further USDM's 20+ years of regulatory expertise, vast knowledge of Oracle SCM Cloud, and understanding of the nuances of CSV/CSA, save customers a significant amount of time. Plus, USDM does not go on vacation or have competing IT priorities so that you can trust your system stays compliant. USDM's subscription services take much of the burden of compliance from the customer, allowing them to focus on more innovative priorities and run their business.
What CSV deliverables does USDM provide as part of the Cloud Assurance for Oracle service?
Cloud Assurance provides the following accelerators and deliverables:
- Vendor Assurance Report
- System Level Risk Assessment (SLRA)
- Validation Plan (VP)
- User Requirements Specification (URS) / Functional Requirements Specification (FRS)
- Configuration Specification (CS)
- Configuration Qualification (CQ)
- Operational/Performance Qualification Test Scripts (OPQ)
- Traceability Matrix (TM)
- Validation Summary Report (VSR)
What is an accelerator versus a deliverable?
At the beginning of each project, customers will receive USDM's Vendor Assurance Report. The Vendor Assurance Report is an in-depth summary of the annual vendor audit. This report is leverageable as documented evidence of the Vendor's procedures and results of the verification and validation activities performed.
The remaining CSV deliverables are customized using USDM proprietary accelerators for each customer and will be delivered as the phases finish in each project. We believe every customer is different and has unique requirements, so we do not provide one-size-fits-all templates. USDM accelerators are fast-start tools based on 20 years of life sciences solution delivery and best practices to ensure rapid execution for your unique needs and deliverables.
Does Cloud Assurance include an impact assessment of Oracle's releases, updates, and patches?
As part of the Cloud Assurance gold-level subscription for Oracle SCM Cloud service, USDM provides an impact assessment of upcoming releases that includes guidance on the required regression testing based on the high-risk areas of the system's core functionality.
How do you maintain compliance for my company's specific configuration of Oracle SCM Cloud?
If you upgrade to USDM's platinum-level Cloud Assurance subscription, USDM provides a customer-specific analysis of Oracle's SCM Cloud releases to ensure all aspects of your unique system configuration are 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.
How do I maximize the benefit of my Cloud Assurance subscription?
To gain greater benefits from of your Cloud Assurance subscription, USDM offers the following additional GxP services. Fees are scoped on a project-by-project basis.
Automated Testing: Cloud Assurance offers optional automated testing that can be added for an additional fee.
Standard Operating Procedures (SOPs): USDM can also provide Administration, Use, and Operations SOPs, End-User SOPs, or Work Instructions for Oracle SCM Cloud (as required per the organization's CSV SOP) for an additional fee.
IS Health Check: USDM offers a free IS Health check that provides a structured journey map designed to scope and plan a more detailed strategy and roadmap. The report indicates the relative state of regulatory compliance and IS efficiency. USDM also offers a more in-depth IS health check for an additional fee.
Senior Program Management: From technical project management to stakeholder communication, trust your project is implemented on-time and on-budget by senior life sciences experts on your behalf. Price to be scoped based on project needs.
Organizational Change Management (OCM): Maximize your IT investments by ensuring your organization embraces and adopts the changes and technology with added OCM training and communications programs. Price to be scoped based on project needs.
Does USDM also support Oracle’s ERP solutions?
Yes, USDM has delivered many Oracle ERP validation projects as well. Read this case study to learn how USDM provided ERP validation services for a global medical device customer in 80% less time, saving them over $350k in costs.
How can I get started with Cloud Assurance for Oracle SCM Cloud?
Contact USDM to learn more and gain peace of mind knowing your cloud compliance is maintained.
Download the Oracle SCM + USDM Cloud Assurance datasheet to learn more