CloudSure
GxP validation built for Oracle Life Sciences Cloud, with accelerators, audit-ready artifacts, and a structured path from scope to evidence.
CloudSure and GxP compliance for Oracle Life Sciences Cloud.
USDM and Oracle have partnered for more than 15 years to help life sciences organizations deploy Oracle platforms with the validation strategy, managed compliance model, and audit-ready evidence needed for regulated cloud operations.
Partnership capabilities
Where we strengthen Oracle for regulated operations.
Oracle Life Sciences Compliance
Managed compliance for Oracle Clinical One, Argus Safety, Siebel CTMS, SCM, NetSuite, and adjacent regulated cloud applications.
Compliant Oracle AI
Validation and governance for AI/ML-assisted features, data integrity controls, audit trails, and ongoing AI compliance currency.
15+ years
Oracle partnership experience supporting regulated life sciences programs.
19 of top 20
Global biopharma companies have trusted USDM for regulated life sciences work.
IQ/OQ/PQ
Validation coverage across Oracle Life Sciences cloud applications and release cycles.
Cloud Assurance™
Subscription-based managed compliance model for ongoing audit readiness.
Oracle page messaging
Three pillars for Oracle Life Sciences Cloud compliance.
Three concise service paths for keeping Oracle Life Sciences Cloud validated, audit-ready, and AI-ready.
CloudSure
CloudSure: GxP Validation Built for Oracle Life Sciences Cloud
CloudSure gives regulated teams a structured path from Oracle Life Sciences Cloud scope to validation evidence — with accelerators, expert execution, and audit-ready artifacts aligned to 21 CFR Part 11, EU Annex 11, and ICH expectations.
- IQ/OQ/PQ coverage across Oracle Life Sciences cloud applications.
- Fast-start accelerators aligned to validated configurations.
- Delivered through USDM Cloud Assurance™ managed compliance.
Managed compliance
GxP Compliance for Oracle Life Sciences Cloud — Fully Managed
USDM manages the Oracle compliance lifecycle across validation planning, release impact, change control, and inspection readiness for Clinical One, Argus Safety, Siebel CTMS, and adjacent regulated Oracle applications.
- Release-impact and regression coverage for Oracle updates.
- Change control mapped to validated configurations.
- Compliance Matrix visibility across the Oracle portfolio.
Compliant AI
Unlock AI on Oracle Life Sciences Cloud — Compliantly
As Oracle embeds AI into clinical, safety, regulatory, and operational workflows, USDM adds the GxP validation layer for controlled adoption, defensible data use, and audit-ready AI behavior.
- Validation frameworks for AI/ML-assisted Oracle functionality.
- Data integrity and audit-trail controls for AI outputs.
- Risk-based approach aligned to emerging FDA AI/ML guidance.
Oracle Clinical One, Safety & GxP Compliance
Oracle Clinical One, Safety & GxP Compliance
USDM supports the regulated Oracle applications where compliance, clinical execution, safety operations, and release management intersect.
Clinical One
Continuous compliance for modern clinical trials.
Oracle Clinical One harmonizes clinical data and workflows. USDM validates the platform, manages release impact, and keeps study teams audit-ready as Clinical One capabilities evolve.
Argus Safety
Safety systems with defensible data controls.
For Argus Safety and pharmacovigilance environments, USDM supports validation evidence, audit trails, data integrity, and inspection readiness.
Oracle portfolio
One compliance model across regulated Oracle applications.
Cloud Assurance connects validation planning, change control, regression testing, traceability, release assessment, and documentation across Oracle Life Sciences Cloud.
Resources
Related Oracle Resources
Oracle resources for buyers evaluating CloudSure, Clinical One, Argus Safety, Cloud Assurance, vendor assurance, ETM.AI, and compliant AI enablement.
Datasheet
Cloud Assurance Certified Datasheet
USDM datasheet for continuous cloud compliance, vendor assurance, validation evidence, and audit-ready cloud operations.
Webinar
Digital Innovation in Life Sciences: Ensure Compliance with Oracle CloudSure
CloudSure webinar covering compliance risk reduction, cloud adoption, Compliance as a Service, and Oracle/USDM operational efficiency.
Webinar
Oracle Clinical One: Next Generation Clinical Trials with Continuous GxP Compliance
On-demand Oracle Clinical One resource focused on centralized clinical trial data and continuous GxP compliance.
Webinar
Oracle Validation and Assurance Virtual Roundtable
Roundtable on Oracle validation, assurance, and regulated cloud operations.
Case study
Streamlining Oracle Clinical One Software Releases
How USDM simplified release management and continuous compliance for Oracle Clinical One.
Case study
Enhancing Regulatory Compliance with Argus Safety Database
Argus Safety validation and implementation support for audit readiness.
Case study
Streamlined Supply Chain Management and Continuous Compliance with Oracle SCM
Oracle SCM validation and continuous compliance through USDM Cloud Assurance.
Blog
How to Leverage USDM’s Vendor Audit of Oracle Supply Chain Management Cloud
How Oracle customers can leverage vendor assurance documentation in risk-based validation.
Blog
ETM.AI: The AI-Enabled Digital Enterprise Trace Matrix
USDM and Oracle approach for AI-enabled enterprise trace matrix management and continuous audit readiness.
Compliance
USDM Cloud Assurance
Managed continuous GxP cloud compliance across Oracle and other regulated cloud platforms.
Official
Oracle Life Sciences
Official Oracle Life Sciences overview for clinical, safety, regulatory, and healthcare data platforms.
Technology partnerships
Want to learn more about our technology partnerships or become an official partner?
Talk with USDM about partner programs, regulated technology adoption, and ways we can help life sciences teams get more value from platforms like Oracle.