Partners
PTC GxP Compliance
Discover a scalable enterprise augmented reality (AR) platform, explore an out-of-the-box product lifecycle management (PLM) system, and accelerate success with an Industrial Internet of Things (IIoT) platform.
PTC uses digital technology to help companies create innovative products, solutions, and workforces. USDM has domain expertise that enables trailblazing outcomes in the life sciences industry.
Cloud Assurance for PTC Software-as-a-Service (SaaS) solutions ensures compliance with the U.S. Food and Drug Administration (FDA)’s 21 CFR Part 11 requirements and validation by way of computer system validation (CSV) and computer software assurance (CSA).
Together, PTC and USDM transform how regulated businesses engage with their customers and employees, minimize the burden of validation, and maintain continuous compliance.
Vuforia | Comprehensive, scalable AR platform that's GMP compliant
Vuforia leverages AR to provide task-specific guidance from an expert’s point of view. Its advanced AR content development solutions help industrial enterprise customers address workforce challenges, improve GMP quality processes and maintenance procedures, and achieve their business goals.
Regulated use cases for Vuforia include:
- Empowering employees with fast and effective training to increase productivity
- Decreasing downtime with faster changeover and maintenance processes
- Reducing scrap, waste, and human error by enabling in-context work instructions
- Conducting virtual audits with the FDA and other regulatory authorities
- Creating standard operating procedures (SOPs)
- Improving quality, safety, and compliance
Learn how USDM helps meet regulatory requirements and improve quality and compliance—read Best Practices for Virtual Audits and Regulatory Inspections.
In this short clip, PTC’s Ryan Orwoll shares how USDM enables customers to streamline their GxP validation review of the PTC Vuforia platform.
Watch the full-length on-demand webinar, New Capabilities with Progressive Technology.
Download USDM's Vendor Assurance Report for PTC Vuforia
Windchill | Enterprise product lifecycle management software
More than ever, manufacturers need real-time information sharing, dynamic data visualization, and effective collaboration. Windchill PLM software enables secure data access for multi-disciplinary and geographically distributed teams, quality-focused processes, and a data-driven approach to manufacturing.
Its open architecture allows integration with other enterprise systems, including IoT devices, and provides comprehensive out-of-the-box functionality. You’re able to expand self-service access of traceable product data while avoiding over-customization and complexity.
ThingWorx | The purpose-built IIoT platform
Industry leaders turn to the ThingWorx IIoT platform for end-to-end capabilities that enable them to address every facet of their digital transformation journey. And with USDM’s Cloud Assurance, using ThingWorx in regulated environments removes the burden of validation and ensures continuous compliance.
Read USDM’s white paper on the benefits of Using PTC’s ThingWorx Solution in a GxP Regulated Environment.
USDM Cloud Assurance for Continuous Compliance
USDM offers a compliant, GMP-ready SaaS solution to improve product quality, accelerate new product introductions, and ensure continuous compliance for pharmaceutical and medical device customers.
We support your life sciences organization by:
- Implementing Quality by Design and enhancing global quality processes
- Reducing the burden of validation and continuous compliance
- Using the CSV or CSA methodology for validation
- Decreasing the cost of managing cloud compliance
Don’t miss out on the latest technology trends shaping the life sciences industry.
Read our 2023 Technology Trends in Life Sciences white paper that includes PTC’s Vuforia AR solution.
Trust and Compliance Capabilities from USDM
Trust encompasses data integrity, security, governance and oversight functions, policy and procedure frameworks, and defensible documentation for audits, assessments, or validation.
Capabilities supporting the pillar of trust and compliance at USDM include:
- Data Integrity and Transparency. Ensuring accuracy, reliability, and clear visibility into data handling processes to build trust with regulators and stakeholders.
- Cybersecurity and Risk Management. Protecting sensitive data and mitigating risks to keep your organization ahead of security threats.
- Continuous Compliance and Validation. Fostering a culture of compliance by adhering to industry standards with automated validation processes.
- Audit Readiness and GxP Support. Maintaining thorough documentation and conducting audits and assessments to ensure compliance throughout the supply chain. Meeting Good Practice (GxP) regulations across domains (i.e., clinical, labs, quality, regulatory, manufacturing, supply chain, and IT).
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