Case studies
See the proof in the data.
70+ case studies showing how regulated life sciences teams improved speed, quality, compliance, and operational performance with USDM.
Performance metrics
Proof you can scan.
See our work in action through real outcomes from regulated life sciences teams.
Fragmentation removed
3 logs to 1 system
Scaling eTMF Completeness for a Hyper-Growth Biotech
View proofAssessment speed
60% reduction
Transforming Third-Party Vendor Risk Management at Enterprise Scale
View proofPerformance visibility
User-level CDMS metrics
User-Level Performance Metrics Help Evaluate Retraining and Staffing Needs
View proofUser-Specific Requirements Configured
25+
From Fragmented to Flow: Enabling Compliant Veeva–Docusign Digital Workflows and eSignatures
View proof
Scaling eTMF Completeness for a Hyper-Growth Biotech
Hyper-growth biotech scaling vaccine clinical-trial operations across multiple Contract Research Organizations (CROs).
How a hyper-growth biotech replaced disconnected eTMF spreadsheets with Veeva Vault workflows for real-time TMF completeness, CRO accountability, and inspection-ready oversight.
Fragmentation removed
3 logs to 1 system
Cycle-time risk eliminated
Up to 3 months
Transforming Third-Party Vendor Risk Management at Enterprise Scale
Global biopharmaceutical company focused on severe autoimmune diseases and cancer, operating in more than 30 countries with a third-party ecosystem of 150+ critical vendors spanning manufacturing, CROs, IT service providers, and logistics partners.
Discover how global biopharma transformed third-party risk management (TPRM) with USDM's continuous monitoring, cutting assessment times by 60%.
Assessment speed
60% reduction
Program scale
150+ vendors
User-Level Performance Metrics Help Evaluate Retraining and Staffing Needs
Life sciences organization running Veeva Vault Clinical Data Management System (CDMS) across multiple clinical trial sites
Discover how USDM's Veeva Vault optimization and advisory services helped a life sciences customer leverage CDMS audit trail analytics to improve clinical site performance, reduce data entry delays, and establish ongoing platform governance.
Performance visibility
User-level CDMS metrics
Targeted action
Site + user signals
From Fragmented to Flow: Enabling Compliant Veeva–Docusign Digital Workflows and eSignatures
Privately-held, family-owned global CDMO specializing in aseptic fill-and-finish for injectable drug products, with roughly €1 billion in annual revenue, 7,000+ employees, and active expansion in the U.S. and Germany.
A pharmaceutical service provider integrates Veeva QualityDocs and Docusign with USDM to streamline GxP workflows and accelerate digital compliance.
User-Specific Requirements Configured
25+
Annual Release Cycles Covered
15+
From Legacy Systems to Intelligent Content Planning
A clinical-stage biopharmaceutical company with a growing clinical pipeline, modernizing fragmented legacy regulatory information management (RIM) systems across its regulatory, clinical, and quality functions.
A biopharma’s journey from legacy RIM systems to intelligent content planning—powered by USDM’s strategic, AI-ready approach.
Annual Savings
$61K+
Projects Delivered
9
AI‑Powered Quality Management for Life Sciences
Clinical-stage vaccine company developing next-generation vaccines for serious bacterial diseases, scaling manufacturing and enterprise-grade quality and IT systems for late-stage trials and commercialization.
USDM helps a leading life sciences company transform quality operations with AI-powered Veeva Vault QMS for speed, compliance, and efficiency.
Risk-prediction accuracy
85%
Earlier issue detection
62%
Building a GxP and GDPR-Compliant Data Warehouse for Biotech Efficiency
Fast-growing global biotechnology company operating across multiple worldwide locations, managing expanding GxP- and GDPR-regulated datasets and sharing data with external vendors and partners.
Discover how USDM built a GxP and GDPR-compliant data warehouse for a biotech company, reducing costs, improving efficiency, and enabling secure data sharing.
Data management time
40% reduction
Annual cost savings
$200K/year
Continuous Compliance for Cloud Computing Biometrics Environment
Leading biotechnology company focused on innovative therapeutics, running a cloud-based biometrics computing environment for research and operational functions.
Learn how USDM enabled GxP compliance for a biotechnology company by qualifying AWS Biometrics, SAS, and RStudio platforms, improving operational efficiency, regulatory adherence, and business continuity.
Platforms Qualified
3
Delivery Model
Fixed-price
Automating AWS Provisioning Through ServiceNow Integration for Enhanced Efficiency and ROI
Mid-sized therapeutics company seeking automated, self-service provisioning of AWS Workspaces and virtual servers through ServiceNow.
Learn how USDM automated AWS provisioning for a mid-sized therapeutics company, streamlining ServiceNow integration, reducing costs, and improving scalability.
ROI Achieved
20%
Provisioning Automation
Zero manual steps
CMDB Remediation for a Mid-Sized Therapeutics Company
Mid-sized life sciences therapeutics company that recently relocated and had no in-house ServiceNow developers.
Discover how USDM improved IT compliance and efficiency for a therapeutics company by optimizing CMDB, automating discovery, and reducing data errors by 25%.
ROI improvement
30%
Reduction in CMDB data errors
25%
Automating Software License Procurement in ServiceNow
Mid-sized life sciences therapeutics company managing software asset licenses and entitlements across vendors in ServiceNow.
Discover how USDM automated software license procurement for a life sciences company, reducing errors, improving compliance, and increasing ROI by 30%.
ROI Increase
30%
Systems Integrated
3
Configuration Management Database Alignment with ServiceNow CSDM
Established enterprise medical device company seeking structured CMDB governance and ServiceNow CSDM alignment across its IT services.
Learn how USDM helped a medical device company optimize CMDB governance with ServiceNow’s CSDM, improving IT efficiency, service mapping, and compliance.
Business Applications Mapped
15
CSDM Diagrams Created
15
Centralized Audit Data Lake Storage and Analytics for Audit Logs
Life sciences company using Microsoft SharePoint and M365 as its document management system to collaborate with Contract Research Organizations (CROs) and clinical teams.
Discover how USDM leveraged Azure Data Lake to centralize audit logs, achieve 100% GxP compliance, cut costs by $200K annually, and drive innovation.
GxP Compliance
100%
Annual Savings
$200K
Ensuring Continuous Compliance and Efficiency with Microsoft Azure DevOps
Global provider of medical imaging systems with more than 4,000 employees operating in a GxP-regulated Microsoft Azure cloud environment.
Azure DevOps solution enabled a medical imaging company to achieve 100% compliance, save $150K annually, and streamline operations by 25%.
Compliance achieved
100%
Annual cost savings
$150K
Streamlining Clinical Trials with the LLM Protocol Assistant
Life sciences company conducting complex, multi-site clinical trials with frequently updated study protocols.
LLM Protocol Assistant improved clinical trial efficiency, reducing costs by $250K annually, cutting protocol queries by 70%, and accelerating timelines by 15%.
Query Reduction
70%
Annual Cost Savings
$250K
Global QC Instrument Compliance and Cybersecurity Remediation – Top Quality Initiative
One of the world's leading independent biotechnology companies, operating Quality Control laboratories across five global manufacturing sites plus AWS and sandbox environments.
Cybersecurity and QC lab instrument remediation case study for a global biotech leader—95% risk reduction, 750 instruments remediated, 24 lab environments validated.
Cybersecurity risk reduction
95%
Instruments remediated
~750
Leveraging AI for Enhanced Clinical Trial Data Management in Life Sciences
A leading life sciences organization focused on clinical research and development, managing data-heavy clinical trials across multiple EDC and non-EDC systems.
Discover how AI enhances clinical trial data accuracy, saves $200K annually, reduces manual effort by 80%, and accelerates timelines by 25%.
Manual effort reduced
80%
Annual savings
$200K
Intelligent Query Monitoring Helps Identify High- and Low-Performing Clinical Sites and Users
Clinical-stage pharmaceutical company running multi-year clinical trials on a Veeva Electronic Data Capture (EDC) platform across multiple clinical sites.
Explore ways to extract business insights from EDC metadata for query metrics, query causes, and query agents.
Review effort reduced
50-60%
Timeline accelerated
10-15%
Daily Monitoring Enables Immediate Action for Security Issues and Continuous Compliance
Clinical-stage pharmaceutical company running clinical trials under global regulatory oversight, using a Clinical Data Management System (CDMS) with admin-level / Vault Owner access controls.
Learn how using a CDMS audit trail supported daily security monitoring, helped detect critical issues, and enabled swift resolutions.
Detection-to-Action Window
Within 24 hours
Manual Review Reduced
80%
Transforming Image Data Processing in Biotechnology with High-Performance Computing (HPC)
Global biotechnology company conducting cutting-edge research, generating large volumes of image data from research microscopes across its labs.
AWS HPC optimized image processing for a biotech firm, cutting costs by 20% and saving over 1,000 hours annually in data management.
Cost reduction
20%
Annual effort saved
1,000+ hours
Enhancing Data Integrity and Accessibility for Antibody Medicine Development with AWS Data Lake
Global biotechnology company specializing in antibody therapeutics for cancer treatment, managing structured and unstructured clinical trial and biomarker data under GxP and GDPR requirements.
AWS Data Lake enabled GxP compliance, cut costs by 25%, improved data access by 50%, and delivered consistent insights for cancer antibody development.
Faster Data Access
50%
Lower Compliance Costs
25%
Solution Strategy for ELN/LIMS Selection and Implementation
Clinical-phase biopharmaceutical company outgrowing manual, paper-based laboratory processes and seeking to scale operations while protecting regulatory compliance and intellectual property.
Learn how a customer properly scoped their project and avoided surprises.
Selection Methodology
2-step
Implementation Phasing
2 phases
Complaint Processing Enhanced by AI in Medical Device Manufacturing
Global medical device manufacturer specializing in patient monitoring equipment for hospitals and medical centers, processing customer complaints and adverse-event reporting across multiple regions.
The AI-based solution mirrored an existing manual decision-tree process to eliminate a backlog of complaints and service records.
Manual resources reduced
75%
Complaint backlog
Eliminated
QC Compliance Managed Services for a Global Biotech Company
Global biotechnology company with quality control laboratories and manufacturing sites across multiple locations worldwide.
Global biotechnology company required assistance with a comprehensive enhancement of its laboratory systems across multiple sites worldwide.
Systems Upgraded
600+
Corporate Priority
Top 3
Enhancing Regulatory Compliance for a Pharmaceutical Manufacturing Company
Pharmaceutical manufacturing company specializing in products for the acute treatment of medical conditions, managing an extensive collection of regulated documents including training records and internal forms.
Learn how USDM seamlessly validated DocuSign for a Pharmaceutical Manufacturing Company.
Validation Deliverables
4
Regulatory Standard Met
21 CFR Part 11
Streamlining Oracle Clinical One Software Releases
Global clinical research company transitioning its clinical study data to Oracle Clinical One, operating with a small in-house quality and validation team.
Discover how the team of experts at USDM simplified release management for a clinical research firm.
Validated System
RTSM + Clinical Studies
Release Cadence Managed
Quarterly
Enhancing Regulatory Compliance with Argus Safety Database
Global biotechnology company implementing an Argus Safety database, with no internal validation lead and pharmacovigilance data residing in a legacy system from a prior organization.
Learn how USDM ensured audit readiness for a global biotech company.
Legacy Safety Data
Fully migrated
Validation Leadership
Gap closed
Efficient Migration and Validation of SAP Workflows to the Cloud
Global clinical trial company running an on-premises SAP ERP environment and subject to FDA regulatory standards.
Discover how USDM supported a global clinical trial company in transitioning its SAP workflows to the cloud.
Validation Timeline
< 4 months
Validation Cost Reduction
40%
Streamline Document Signing with Built-In Continuous Compliance
Clinical-stage biotechnology company with a distributed, work-from-home workforce operating in an FDA-regulated environment.
Learn how USDM validated DocuSign for a biotech company with a remote workforce, enhancing efficiency and flexibility.
Validation Deliverables
5
Compliance Standard
21 CFR Part 11
Streamlined Supply Chain Management and Continuous Compliance with Oracle SCM
Global clinical trial company operating regulated GxP facilities across North America and Europe, adopting a cloud-based ERP to streamline supply chain management.
Learn how USDM efficiently validated Oracle SCM for a global clinical trial company.
Time to Validated Go-Live
< 9 months
Phased Validation Approach
2 phases
Simplified Change Control Management and Continuous Validation for Oracle SCM
Global medical technology company running Oracle SCM as its cloud-based ERP in an FDA-regulated, GxP environment.
Learn how USDM helped a global medical technology company develop a customized validation and regression testing plan to manage Oracle SCM patches and updates.
Release Cadence Managed
Quarterly
Validated State
Continuous
GxP System Validation and Monitoring for Half the Cost
Newly commercialized emerging therapeutics company managing eight GxP-compliant SaaS systems under stringent regulatory requirements.
Learn how an emerging therapeutics company saves more than $400k annually and maintains SaaS systems for half that cost.
Annual Savings
$400K+
Manual Workload Cut
80%+
eSignature Transforms Workflows for Leading Biotech Company
A leading biotechnology company developing biologic medicines, burdened by paper-based, wet-signature document workflows in a regulated environment.
Learn how a leading biotech company improved efficiencies and saved costs with Cloud Assurance for DocuSign.
Cost Per Wet Signature
$50
Signees Per Document
4
Clinical-Stage Oncology Company Automates Regulated IT Workflows with ProcessX
Pre-commercial, clinical-stage precision oncology company with minimal existing IT systems and a need to scale regulated GxP operations rapidly.
Turning Point, a pre-commercial, clinical-stage precision oncology company, was achieving great clinical results needed to ramp up its IT systems rapidly.
Workflows requested
2
Workflows delivered
6
Fast DocuSign Validation and SOPs for Clinical-Stage Biopharma Needing GxP System Expertise
A clinical-stage biopharmaceutical company with a small team of roughly 20 employees and no in-house computer system validation expertise.
Learn how USDM’s eSignature system experts helped Xequel Bio streamline its document signing process.
Delivered ahead of schedule
33%
Time to validate
2 weeks
USDM Designs AWS Data Lake to Standardize GxP Data Management Processes
Global biotechnology company specializing in antibody therapeutics for cancer, with 1,000+ employees and operations across four global offices.
Learn how USDM helped a global biotechnology company reduce maintenance, security, and compliance costs by implementing a single centralized data platform that is GxP and GDPR-compliant.
Maintenance Cost Reduction
30%
IT Hours Reclaimed
1,200 hrs/yr
Centralized Clinical Data Lake and Analytics
Life sciences company specializing in the development and manufacturing of acellular tissues for treating diseases, injuries, and chronic conditions, managing regulated clinical trial and biostatistics data across multiple Contract Research Organizations (CROs).
Explore how USDM implemented an AWS Clinical Data Lake to achieve 100% GxP compliance, save $500K annually, and enhance analytics reporting.
GxP Compliance
100%
Audit Prep Time
60% reduction
Cloud Assurance Helps a Specialized Life Sciences Company Expand DocuSign for Global GxP Usage
Global pharmaceutical and medical device company with more than 4,000 employees and operations in over 60 countries, spanning research, development, marketing, and sales of regulated GxP products.
Learn how USDM’s rapid validation and implementation of DocuSign helped a global life sciences company expand their GxP environment for DocuSign in 2 months.
Time to Go-Live
2 months
Global footprint supported
60+ countries
Cloud Assurance for DocuSign Decreases Immunotherapeutic Company’s Validation Costs by 33%
Clinical-stage immunotherapeutic company with a small Quality Assurance team and no in-house IT function.
Learn how USDM helped an Immunotherapeutic company with a cost-effective, rapid solution for the initial validation implementation activities of its electronic document management system.
Validation cost reduction
33%
Recognized signature value
$10,000
Pharmaceutical Company Transitions to CSA Model with USDM Expertise
Large pharmaceutical company focused on research, development, and manufacturing across dermatology, oncology, and specialty injectable therapeutic areas.
Learn how USDM helped a pharmaceutical company achieve greater efficiencies in their validation process through a hybrid CSA model for testing.
Scripted Tests
Significantly reduced
Mindset Shift
Documentation-focused to testing-focused
Clinical Compliance as a Service
Global pharmaceutical company with $16B in annual revenue running 40-50 clinical studies per year across EDC, IRT, and ePRO systems.
Learn how USDM reduced clinical study time and costs for a $16B pharmaceutical company with managed services for EDC, IRT, and ePRO systems.
Faster EDC UAT
110 to 24 hours
Shorter database lock
40 to 14 days
Box Meets Complex Security and Global GxP Validation Requirements
Global biosciences company founded in China with U.S. locations, developing infectious disease treatments (including COVID-19) and in Stage II clinical trials, with limited in-house computer system validation and GxP regulatory experience.
Discover how USDM enabled FDA-ready Box GxP validation for a global biosciences company, meeting tight deadlines and complex security requirements.
Global CSV Outcome
Defensible
Regulatory Coverage
Part 11 + Annex 11
510(k) Approval Weeks Ahead of Deadline
A medical device software company formed by two of the largest blood centers in the U.S. to deliver a next-generation Blood Establishment Computer Software (BECS) platform for compliant, nationwide blood supply chain management.
Case study on 510(k) Approval Weeks Ahead of Deadline.
Documents Reviewed
100+
Effort Saved
80 man-hours
Box GxP and Cloud Assurance for FDA Submission
Global clinical-stage biopharmaceutical company developing novel drugs for chronic liver, gastrointestinal, and metabolic disorders, with operations in China and the United States and limited in-house CSV and GxP expertise.
Case study on Box GxP and Cloud Assurance for FDA Submission.
Validation Timeline
2 months
Headcount Avoided
3 FTEs
Veeva Vault Implementation to Maximize GxP Uses
An emerging, clinical-stage, Phase 1 biotechnology company with fewer than 150 employees, replacing a legacy regulatory submissions application.
Case study on Veeva Vault Implementation to Maximize GxP Uses.
Delivery
On time, on budget
Company stage
Phase 1, <150 employees
Trustworthy, Rapid Remediation to Address FDA 483 Warnings
Commercial biotechnology company with approximately $12B in revenue facing FDA 483 observations and open CAPAs.
Case study on Trustworthy, Rapid Remediation to Address FDA 483 Warnings.
Client Scale
$12B
Root Cause
Identified
Optimized Use of TraceLink Helps Pharma Company Implement Serialization
Specialty pharmaceutical company focused on autoimmune disease therapies, with no prior serialization experience and no in-house TraceLink expertise.
Case study on Optimized Use of TraceLink Helps Pharma Company Implement Serialization.
Delivery
On Time, Under Budget
Validation Burden
Significantly Reduced
Box GxP for Controlled Clinical Management
Pre-commercial oncology research company running multiple drug programs in Phase 2, with IT and Clinical Data Management teams that needed a controlled, GxP-compliant environment for clinical collaboration and SAS dataset storage.
Case study on Box GxP for Controlled Clinical Management.
Implementation Time
< 30 days
Validation Effort
50% less
ERP Validation in 80% Less Time!
Global medical device company with approximately 2,000 employees, $1B in annual revenue, and products sold in 50 countries, upgrading its Oracle EBS ERP system.
Case study on ERP Validation in 80% Less Time!.
Faster Validation
80%
Cost Avoided
$350K
DocuSign in 7 Days to Enable eSignatures for Remote Work
Biopharma company at the forefront of cancer treatments, transitioning to remote work during the COVID-19 pandemic.
Case study on DocuSign in 7 Days to Enable eSignatures for Remote Work.
Time to Go Live
7 days
Validation Effort Reduced
90%
Validation of SharePoint for GxP Content Management Solution
Clinical-stage biopharmaceutical company developing targeted cancer therapies, with a pipeline of internally discovered investigational drugs.
Case study on Validation of SharePoint for GxP Content Management Solution.
GxP-Validated System
SharePoint Online
IT Expense
Minimized
FDA Mandated Global CSV Remediation
Global medical device company with $7.5B in annual revenue and more than 100,000 products commercially available, operating enterprise and business-unit GxP systems across cloud, in-house, LMS, ERP, lab, manufacturing, and clinical environments.
Case study on FDA Mandated Global CSV Remediation.
Scope Reduced
Over 80%
Delivered Under Budget
$600k
Master Data Management and Validation to Meet Global Requirements
Large medical device and diagnostics company with three global business sectors and ten operating units managing siloed product data sets.
Case study on Master Data Management and Validation to Meet Global Requirements.
Revenue Protected
$15B+
Operating Units Unified
10
Improved UDI Data Integrity with Single-Source-of-Truth
Global manufacturer of biotech, pharma, medical device consumer products, and supplements managing 300k products across 60+ systems.
Case study on Improved UDI Data Integrity with Single-Source-of-Truth.
Annual Savings
$500k
Data Growth Absorbed
>3,000%
Upgrade to Oracle ERP Cloud and Transition from CSV to CSA
Clinical-stage biopharmaceutical company developing immune, fibrotic, and immuno-oncology therapies, with operations across multiple U.S. sites.
Case study on Upgrade to Oracle ERP Cloud and Transition from CSV to CSA.
Delivery Timeline
6 months
Cost Savings
~40%
Customized CPET Analysis Workbook
Clinical research sponsor analyzing cardiopulmonary exercise test (CPET) data collected across multiple investigator sites.
Case study on Customized CPET Analysis Workbook.
QC Verification
75% reduction
Analysis Time
25% reduction
MDSAP Ready in 4 Months Through Assessment and Remediation
Large global medical device company with a newly formed Quality leadership team and a commercial scientific-research device that had recently received approval for clinical use.
Case study on MDSAP Ready in 4 Months Through Assessment and Remediation.
MDSAP Audit-Ready
4 months
Documents Remediated
230+
Biotech Completes 70% of eSignatures Within 24 Hours
Medium-sized biotechnology company focused on enzyme replacement therapies, using DocuSign across 1,300+ users for GxP and non-GxP documents.
Case study on Biotech Completes 70% of eSignatures Within 24 Hours.
Signature speed
~70% within 24 hours
GxP turnaround
32% faster
CSV Program and Application Validation in Less than 6 Weeks
Pre-commercial biotechnology company implementing EDC and eCTD publishing capabilities ahead of patient enrollment and an FDA submission, with no computer system validation procedures in place.
Case study on CSV Program and Application Validation in Less than 6 Weeks.
Time to validated systems
<6 weeks
Faster implementation
77% faster
Quality System Upgrade to Meet EU MDR and EU IVDR
Large medical device manufacturer selling products across multiple countries, with a quality management system and 400 SOPs requiring review to meet EU MDR recertification requirements.
Case study on Quality System Upgrade to Meet EU MDR and EU IVDR.
Timeline
< 8 months
Revenue Risk Reduced
$3B
Comprehensive SAP Validation Effort, Time Reduced by Over 50%
Global pharmaceutical contract manufacturing organization with eight independently incorporated facilities across the United States and European Union, providing sterile fill-finish of injectables, oral solid dose drug products, and primary and secondary packaging.
Case study on Comprehensive SAP Validation Effort, Time Reduced by Over 50%.
Validation timeline reduction
Over 50%
Fewer testing requirements
Nearly 40%
Huge Productivity Gains and Decreased Costs with Salesforce
Fortune 500 medical device manufacturer with 15,000 products sold worldwide, managing complex global GxP approval and product registration processes across an M&A-expanded organization.
Discover how USDM helped a Fortune 500 medical device manufacturer streamline workflows, save $750K annually, and achieve compliance with Salesforce GxP.
Annual Savings
$750K
License Expense Reduction
85%
GxP QMS Framework Prepares Emerging Biopharma for Commercialization
Emerging biotechnology and pharmaceutical company with roughly 200 employees, in pre-commercial, phase-3 late-stage clinical drug trials.
Case study on GxP QMS Framework Prepares Emerging Biopharma for Commercialization.
QMS Remediation Timeline
Under 6 months
New Procedures Delivered
50+ SOPs
Biopharma Company Saves $500k by Qualifying Salesforce
Leading global biopharmaceutical company with more than $30B in annual revenue and over 8,000 employees running dozens of enterprise platforms.
Case study on Biopharma Company Saves $500k by Qualifying Salesforce.
First-Year Savings
$500k+
Scale Supported
8,000+ employees
AI Chatbots to Support GxP Content for Clinical Trials
Top 5 global pharmaceutical company with operations across 155 countries, running regulated clinical trial processes on Microsoft Azure DevOps.
Case study on AI Chatbots to Support GxP Content for Clinical Trials.
Faster regulatory info delivery
30%
Faster solution deployment
40%
Complaint Handling Integration with Salesforce Improves Patient Care
An FDA-cleared medical device company with a patient-based app, patented micro-sensor and Bluetooth technology designed to deliver value-based care and reinforce adherence to treatment.
Case study on Complaint Handling Integration with Salesforce Improves Patient Care.
Time to qualification
3 months
Call center throughput
2x call volume
Complaints Remediation to Meet FDA Consent Decree Deadline
Global medical device company operating under an FDA Consent Decree, with a backlog of more than 600,000 service orders and complaints.
Case study on Complaints Remediation to Meet FDA Consent Decree Deadline.
Service Orders Remediated
600,000+
Dedicated Consultants
36
Onsite and Remote On-Demand Compliance Staff Augmentation
SaaS life sciences supply chain software vendor with a customized product for biopharma that supports GxP business processes and ships custom configurations and validation to a growing customer base.
Case study on Onsite and Remote On-Demand Compliance Staff Augmentation.
Faster Validation
50%
Lower Validation Costs
50%
Accelerating Compliance for Better Business Outcomes
Fortune 1000 medical device manufacturer with approximately 15,000 products distributed globally and compliance activities spanning multiple divisions and sites.
Case study on Accelerating Compliance for Better Business Outcomes.
Resources Required
50% fewer
Delivery Speed
50% faster
Actionable Cybersecurity Roadmap for a Growing Pharma Company
U.S.-based pharmaceutical company with a global footprint and a strong product pipeline, recently transitioning from an outsourced IT model to an internal IT capability.
See how USDM helped a pharmaceutical company assess cybersecurity readiness, mitigate breaches, and develop a tailored roadmap for global compliance.
Roadmap delivered
4 weeks
Discovery depth
12 hours
Medical Device Company Updates 450 QMS SOPs in time for EU MDR
Large medical device company restructuring into a centralized corporate quality organization, with roughly $1B of EU revenue dependent on EU MDR compliance.
Case study on Medical Device Company Updates 450 QMS SOPs in time for EU MDR.
QMS SOPs Updated
450
Time to Complete
1 Month
Training Records Completed 80% Faster
Global commercial biotechnology company with roughly $11B in annual revenue and more than 10 therapies commercially available, replacing a paper-based learning management practice.
Case study on Training Records Completed 80% Faster.
Faster training record submission
80% faster
Time to deploy and validate
18 days
Rapid Deployment of Enterprise-Wide GxP Applications
An emerging biotechnology company nearing its first FDA submission, deploying its first-ever GxP applications to enable commercialization.
Case study on Rapid Deployment of Enterprise-Wide GxP Applications.
Faster Implementation
50%
Audit-Ready
12 weeks
Auditing-as-a-Service Delivered 80% More Efficient Audits
Leading global biotechnology company developing innovations for complex diseases, with hundreds of vendors critical to the development and worldwide distribution of a blockbuster drug.
Case Study: USDM revamps antiquated auditing process to save customer’s time and money
Faster Audits
80%
Annual Savings
$112k
USDM Managed Compliance Program
Global contract biopharmaceutical manufacturer (CMO) in heavy acquisition mode, rapidly bringing new plants online with minimal in-house compliance experience and no global compliance program.
Case study on USDM Managed Compliance Program.
Validation cost reduction
25%
Deployment savings
$570K
CSA Approach Significantly Improves Platform Efficiencies
Large global biotechnology company ($100B in revenue) running its Force.com platform for non-GxP processes, with IT, Quality, and Informatics teams seeking to expand the platform to regulated GxP use cases.
Case study on CSA Approach Significantly Improves Platform Efficiencies.
Validation Cost & Time
50% decrease
Testing Overhead
Significantly reduced
Start here
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