At US Data Management (USDM), we distinguish ourselves by offering our clients both domestic and international PLM regulatory compliance services. Our global presence provides breadth and depth in our PLM compliance practice enabling our USDM expert services team to handle the most complex problems. With increased product development complexities coupled, with strict regulatory enforcement of enterprise systems in the Life Science industry, bringing products to market on time, within budget and compliant, becomes a difficult challenge for many companies today. Utilizing our expert services team and Validation Accelerator Pack (VAP) solutions, USDM has assisted over 100 Life Science companies in working through these compliance challenges.
Based on our reputation for providing professional consultants and our ability to deliver creative compliance solutions, clients come to USDM. Our expert services team applies GAMP 5 and other validation best practices to maximize each client’s productivity.
Business Challenges
Over the past decade, government regulatory agencies have taken a harder position with system validation for life science companies resulting in a significantly higher volume of recalls and warning letters. Furthermore, the use of off-the-shelf PLM software in the medical device, pharmaceutical and biotechnology industry to support automated processes in design collaboration, manufacturing and quality systems operations is increasing to meet market demands. USDM expert services and VAPs are a principle means of preventing product recalls and creating and maintaining a validated state.
Our goal is to enable Life Science companies to
- Decrease validation costs
- Accelerate software deployment time
- Achieve and maintain compliance
- Improve software ROI
- Simplify, unify and optimize business & compliance objectives
USDM Consulting Services
USDM consulting professionals are experts in performing risk assessment, vendor selection and auditing, implementation, compliance and validation services using a best-practices approach that expedites the compliance process and minimizes costs. Our consultants work closely with client representatives, software engineers and end-users to ensure that the business needs (e.g., business, functional and compliance requirements) are properly articulated for efficient testing to minimize execution time and costs.
In addition to hands-on experience with PLM applications, our USDM team offers in-depth knowledge and expertise in the following
- Europe, Asia, Latin America regulations
- FDA regulations (e.g., 21 CFR Parts 11, 210, 211 and 820) relevant to PLM
- cGXP (i.e., GLP, GCP and GMP)
- Development of validation/qualification documentation packages and SOPs
- Execution of validation/qualification protocols and test plans.
Validation Accelerator Packs (VAPs)
The USDM VAPs provide life science companies with an industry best practice tool to simplify compliance, increase productivity and minimize costs. The VAPs are a complete set of validation document templates for PLM applications. The VAPs are based on standard requirements for life science companies and contain the following compliance documentation:
- Computer System Validation Plan
- Risk Assessment
- System Requirements Specification
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Traceability Matrix
- Standard Operating Procedure Checklist
- Validation Summary Report
VAP benefits include
- Complete set of validation document templates for PLM applications requiring validation
- Templates based on standard requirements for life sciences
- Designed to select the components needed
- Updated templates for client specific configuration
- Demonstrated savings of 40% - 60% on validation effort
Oracle Agile 9.3 VAP Upgrade Program
USDM, a member of the Oracle® PartnerNetwork, has teamed with Oracle to provide a comprehensive solution to support FDA Part 11 software validation requirements for Oracle Agile PLM and Oracle GRC Manager applications. To support the new release of Oracle’s Agile version 9.3 application, USDM now offers the VAP 9.3 Upgrade Program. This program includes VAP compliance templates, project management and validation services to deliver a cost effective validation project while managing quality and implementation risks.
Please review our USDM Validation Accelerator Pack Program
USDM Business Value
Our USDM mission is to create solutions for life science customers which meet PLM compliance initiatives by delivering the highest level of expertise to assist clients in realizing the highest value from PLM investment.
Our ability to provide a complete compliance solution throughout the PLM lifecycle differentiates USDM from our competitors and allows us to provide comprehensive compliance advice to a wide variety of PLM systems and other enterprise applications. We work with clients from vendor evaluation to implementation and post-implementation in order to create and maintain a validated state. Our strong Life Science and technology base includes specialists in various disciplines such as Enterprise Content Management (ECM), Laboratory Systems, and Clinical Automation. Utilizing USDM service affords the following benefits:
- Faster implementation times and better system performance
- Decrease validation time by 40-60%
- Decrease validation costs by 50%
- Simplify and unify compliance documentation for all applications
- Deliver unified templates, unified best practice approach to risk assessments, validation and compliance
- Educate users on good compliance practices to maintain the validated state
IT departments in the life science industries are constantly facing tremendous business challenges such as higher costs, lower budgets, higher demand ...