Oracle GxP Compliance
Oracle Clinical One, Oracle Supply Chain Management & NetSuite GxP Compliance
Oracle Supply Chain Management (SCM)
USDM Life Sciences and Oracle have partnered for more than 15 years to provide world-class solutions that enable life sciences companies to meet FDA 21 CFR Part 11 regulatory requirements. USDM delivers a trustworthy service that expertly manages GxP compliance for Oracle SCM customers.
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 methodologies, along with our automated testing tools, USDM provides Oracle SCM Cloud customers an efficient and cost-effective way to achieve and sustain compliance.
Oracle SCM is Cloud Assurance Certified
Oracle SCM is among a select group of technology providers committed to serving and advancing the life sciences industry. As a Cloud Assurance Certified Technology, users can trust that Oracle SCM is an excellent choice to achieve and maintain regulatory compliance globally. As part of this certification, USDM publishes our Vendor Assurance Report to establish Oracle SCM’s credibility and compliance maturity.
You can download our Vendor Assurance Report that details the results of our rigorous assessment by filling out the form on this page.
Read this blog to learn how to leverage USDM’s audits for Oracle Cloud.
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
Read this case study to learn how USDM helped a medical device customer to execute their Master Data Management (MDM) process to prepare for the EU MDR deadline with Oracle Cloud.
Download the Cloud Assurance for Oracle SCM datasheet to learn more.
Download USDM's Vendor Assurance Report for Oracle Cloud
Oracle Clinical One
Clinical trials have been plagued with process redundancy and inefficiency due to siloed data, fragmented technologies, and inconsistent operational practices. Today’s study teams and sites rely on a collection of siloed point solutions that simply weren’t built to work together. What if you could build a study once, enter data once, and do everything in one place?
Oracle Clinical One is a unified eClinical platform that harmonizes data, streamlines workflow, and saves significant time from study startup to study closeout. In partnership with USDM Life Sciences, the Oracle Clinical One platform offers a GxP compliant solution to ensure that systems are validated correctly and remain in a state of continuous compliance with USDM Cloud AssuranceTM
Experience End-to-End GxP Compliance
With a powerful, integrated approach to performance and compliance, USDM Cloud Assurance and Oracle’s Clinical One eClinical platform spearhead centralized clinical trial data while ensuring continuous regulatory compliance.
- Enable the move to Oracle Clinical One for life sciences customers
- Increase speed and adoption of Clinical One, including new product features and capabilities
- Ensure your entire Clinical One capabilities are continuously compliant
- Decrease the cost and time of managing compliance
- Reduce adoption, implementation, and validation time
- Harmonize and centralize control of your GxP processes
- Maintain continuous cloud compliance with every new release managed by USDM
- Enable a platform of compliant technology solutions
NetSuite GxP Compliance
NetSuite provides superior manufacturing resource planning, leaner production processes, and improved supply chain management, benefiting organizations in the life sciences industry such as pharma and biotech. The healthcare and life sciences landscape is undergoing massive changes, leading to increased pressure to control costs and adapt to evolving regulatory and competitive conditions. To remain competitive, organizations must be able to respond quickly to market demands and changing regulations. With over 33,000 customers, NetSuite’s cloud-based business management suite helps healthcare and life sciences organizations increase visibility, reduce complexity, and remain agile in the face of dynamic changes.
The essence of USDM’s partnership with Oracle is to:
- Facilitate the initial validation process and reduce both the time and cost.
- Assure the system remains validated thought the Oracle releases and customer changes.
How USDM reduces the compliance burden for NetSuite customers:
- Vendor Audits & SDLC Procedures
- QMS Requirements (GxP/HIPPA)
- OPQ Testing Protocols
- Regulated Use Cases & Procedures (SOP)
- Item & Material Management
- Material Status Controls
- Product Revisions, Change Controls
- CFR Part 11 Compliance
- E-Records & Audit Trails
- E-Signatures for: Product & Material Management, Manufacturing Controls, Receiving Inspections & Approvals, Manufacturing Operations, Quality Inspections, UDI for Medical Devices
Watch our on-demand webinar: NetSuite for GxP, Regulated Use Cases
Frequently Asked Questions
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.
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.
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)
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.
To gain greater benefits from 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.
Contact USDM to learn more and gain peace of mind knowing your cloud compliance is maintained.