Validated cloud and SaaS validation
Maintain validated cloud and SaaS systems as vendors release updates, configurations change, and business teams expand regulated use.
USDM Cloud Assurance
USDM Cloud Assurance for validated cloud that stays validated.
USDM Cloud Assurance helps life sciences companies maintain GxP validated cloud and SaaS validation evidence as vendors release updates, users expand adoption, and 21 CFR Part 11 obligations keep following the system.
Validated cloud
SaaS validation
Part 11 evidence
Why USDM Cloud Assurance
Cloud validation is no longer a launch event.
A validated cloud system can become stale without a dramatic failure. A vendor changes a feature, a role changes permissions, a workflow expands to new users, or a release note quietly affects a regulated function. Cloud Assurance turns that drift into a managed compliance process.
21 CFR Part 11 validation evidence
Keep electronic records, eSignatures, audit trails, access controls, and validation records aligned with intended use and inspection expectations.
Cloud assurance subscription model
Shift recurring release assessment, testing, documentation, and monitoring into a managed operating model with repeatable evidence.
GxP validated cloud operations
Connect vendor qualification, impact assessment, change control, test execution, release notes, and audit-ready documentation after go-live.
Proof in the data
Case studies that show Cloud Assurance in action.
Check out these case studies that show real outcomes across DocuSign, Box, Veeva, SaaS validation, continuous monitoring, and CSA risk-based validation to simplify compliance.
33%
validation cost reduction
A clinical-stage immunotherapeutic company reduced DocuSign validation costs while keeping the EDMS continuously 21 CFR Part 11 compliant.
Read case study$400K+
annual savings
An emerging therapeutics company cut GxP SaaS validation and maintenance costs in half across eight GxP systems.
Read case study2 months
validated global rollout
USDM expanded DocuSign for global GxP use while meeting FDA 21 CFR Part 11 and Japan-specific regulatory requirements.
Read case study80%
less validation time
A risk-based validation model reduced an Oracle ERP validation timeline by 80% and saved $350K.
Read case studyHow it works
The cloud assurance subscription is a controlled loop.
The operating model connects vendor change, regulated intended use, risk-based validation, and inspection-ready evidence. That is the difference between “we validated it once” and “we can defend it today.”
01
Qualify the vendor and intended GxP use
02
Establish the validated baseline
03
Assess each release and configuration change
04
Test what matters based on risk
05
Refresh validation evidence and approvals
06
Monitor controls for drift after release
What USDM manages
Validation maintenance for the systems that keep changing.
Release impact assessments and risk-based testing
Validation plans, reports, traceability, and controlled evidence
Vendor qualification and cloud release management
21 CFR Part 11 controls for electronic records and signatures
Configuration reviews, audit trail review, and exception follow-up
Validated cloud guidance
USDM Cloud Assurance is built for validated cloud, GxP validated cloud, SaaS validation, cloud assurance subscription models, and 21 CFR Part 11 validation.
The service is designed for regulated cloud platforms where ongoing change is normal but evidence still has to be current, controlled, and defensible.
Cloud Assurance content cluster
Keep moving through the Cloud Assurance library.
Cloud Assurance article
USDM Cloud Assurance: Continuous GxP Compliance for Modern Life Sciences Systems
Open resourceBlog
USDM Cloud Assurance GxP Compliance for Life Sciences
Open resourceBlog
Cloud Assurance Certified: What Does It Mean?
Open resourceBlog
Data in the Cloud Can Be 21 CFR Part 11 Compliant
Open resourceWhite paper
Regulated GxP Workloads in the Public Cloud
Open resourceCapability
21 CFR Part 11 Compliance
Open resourceFAQ
Questions buyers ask about validated cloud.
What is USDM Cloud Assurance?
USDM Cloud Assurance is a managed compliance service for life sciences cloud and SaaS systems. It helps teams implement, validate, monitor, and maintain regulated cloud environments with ongoing evidence instead of treating validation as a one-time project.
How does USDM Cloud Assurance support validated cloud systems?
It supports validated cloud systems by managing vendor qualification, impact assessment, risk-based testing, release documentation, change control evidence, and ongoing monitoring as platforms change over time.
Does Cloud Assurance help with SaaS validation?
Yes. Cloud Assurance is built for SaaS validation in GxP environments where vendors release frequent updates and internal teams need a repeatable way to assess impact, test critical functions, and preserve inspection-ready evidence.
How does Cloud Assurance relate to 21 CFR Part 11 validation?
For systems that support electronic records or electronic signatures, Cloud Assurance helps maintain evidence around access control, audit trails, eSignature controls, intended use, testing, and release impact so 21 CFR Part 11 expectations stay defensible after go-live.
Next step
Find the validation work that should not be living in release chaos.
USDM can assess your validated cloud and SaaS portfolio, identify recurring compliance burden, and define where a Cloud Assurance subscription model makes the biggest impact.