PTC GxP Compliance

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Accelerate digital transformation across your value chain to ensure business continuity, maximize revenue and improve patient outcomes with GxP compliance

Disruption is happening everywhere—from supply chain issues to workforce attrition to your competitors taking market share. PTC helps companies thrive in these conditions by giving them the “Power To Create” more innovative products, solutions, and workforces.

To navigate this ever-changing landscape, industrial companies need a technology partner to help them survive—and thrive—by rapidly accelerating digital transformation across their products, operations, and workforce. That’s where PTC shines.

PTCs unique portfolio of Industrial Internet of Things (IIoT), Augmented Reality (AR), and Product Lifecycle Management technologies work together to establish a digital thread that spans the entire product lifecycle, enabling faster data continuity across your business and better collaboration between your teams.

In partnership with USDM, Cloud Assurance for PTC SaaS solutions enables PTC customers to achieve compliance with the FDA’s 21 CFR Part 11 and global computer system validation and computer software assurance requirements.

Together, PTC and USDM transform how regulated businesses engage with their customers and employees and minimize the burden of validation to keep GxP systems in compliance.

ThingWorx | The industry-leading industrial IoT platforms

If you’re considering IIoT platforms, you should evaluate their capabilities. Unlike other industrial IoT software, ThingWorx offers a complete IIoT platform. Industry leaders turn to ThingWorx for end-to-end capabilities—enabling them to address every facet of their digital transformation journey. With USDM’s Cloud Assurance using ThingWorx in regulated environments removes the burden of validation and ensures continuous compliance.

Read our white paper on the benefits of Using PTC’s ThingWorx Solution in a GxP Regulated Environment.

Vuforia | Comprehensive, scalable AR platform with GMP compliance

Vuforia remains the market leader in the competitive augmented realty (AR) landscape by leveraging AR to provide task-specific guidance from the point of view of an expert. Vuforia delivers the fastest, easiest, and most advanced AR content development solutions to help industrial enterprise customers address workforce challenges and business goals –USDM helps meet regulatory requirements and improve quality and compliance.

Regulated use cases for Vuforia include:

  • Faster, more effective training to increase worker productivity
  • Scale manufacturing expertise and decrease downtime with faster changeover and maintenance
  • Decrease scrap and waste by reducing human error and in-context work instructions
  • Facilitate SOP creation
  • Improve quality, safety, and compliance

With augmented reality, you can improve the execution of critical GMP quality processes and maintenance procedures. Vuforia also makes virtual audits with the FDA or other regulatory authorities possible. Read our Best Practices for Virtual Audits and Regulatory Inspections to learn more.

In this short clip from our most recent webinar, hear PTC’s Ryan Orwoll discuss the value of USDM’s partnership in enabling PTC’s customers to streamline their GxP validation review of the PTC Vuforia platform.

To watch the full-length on-demand webinar, click here

Windchill | Enterprise product lifecycle management software

Manufacturers have never needed real-time information sharing, dynamic data visualization, and the ability to collaborate more than they do today. With easy, secure data access for multi-disciplinary and geographically distributed teams, quality-focused processes, and a data-driven approach to manufacturing, Windchill is elevating how product development gets done.

Windchill’s open architecture enables easy integration with other enterprise systems, including IoT, providing a solid foundation for a product-driven digital thread. PTC’s PLM system provides comprehensive out-of-the-box functionality and highly configurable role and task-based apps. Expand self-service access of traceable product data to non-experts who don’t typically use PLM while avoiding over-customization and complexity.

Cloud Assurance for PTC

PTC and USDM offer a compliant, GMP-ready SaaS solution to address pharmaceutical and medical device customers’ needs to improve product quality, accelerate new product introductions, and ensure continuous compliance.

Together we support your business by:

  • Implementing Quality by Design and enhanced global quality processes
  • Significantly reducing the burden of validation and continuous compliance to meet regulatory requirements
  • Utilizing a validation methodology and toolkit successfully audited by regulatory agencies and following FDA’s Computer Software Assurance (CSA) recommendations
  • 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 inclusive of PTC’s Vuforia AR solution.