Product regulatory compliance is a major part of business, especially in industries such as medical devices, pharma, automotive, consumer goods, and aerospace and defense. The detailed documentation and reporting around compliance regulations require intensive effort—and penalties for non-compliance can be harsh, taking the form of severe fines, bans on selling products, and added testing and reporting requirements.
Almost every industry has product regulatory compliance requirements.
Windchill PLM for Automated Compliance Processes
Product regulatory compliance is a primary focus for these organizations, consuming a large number of FTEs and substantial chunks of available budgets. Without product lifecycle management (PLM), compliance requires constant attention to ensure data completeness, accuracy, and timely reporting. However, with the right PLM compliance tools, these processes can be simplified and, in many cases, built to be completely automated.
Windchill Is the PLM Compliance Backbone
We’ve been talking about PLM as the backbone of the digital thread for a long time, which makes perfect sense. PLM is the only enterprise application that includes information about every phase of a product’s lifecycle—from design and prototyping, through manufacturing, and during after-sales service and support. As a result, PLM acts as a single source of truth critical to feeding the digital thread information, including as-built drawings, as-maintained data, ECNs applied, CAPA info, and more.
A digital thread is exactly what companies need to ensure they are tracking and reporting the necessary data for product regulatory compliance, making PLM an essential compliance tool.
PLM is the backbone of the digital thread, and the digital thread is a requirement for efficient product regulatory compliance.
Regulatory Hub: Reporting for Product Regulatory Compliance
PTC Windchill includes the Regulatory Hub, a built-in solution that:
- Enables traceability and audit readiness
- Ensures adherence to best practices
- Automates time-consuming manual processes to minimize regulatory overhead
The Regulatory Hub generates regulatory submissions on-demand from a single consistent repository that is automatically synchronized with engineering data and data from other integrated enterprise applications. In addition to helping file reports, Windchill’s Regulatory Hub can automate and track training and SOP usage.
Windchill’s Regulatory Hub automates and simplifies the regulatory compliance submission process.
The DHF—design history file—in the Regulatory Hub standardizes data from multiple disparate systems across geographies, projects, and departments. This cohesive dataset helps speed time to market, reduces errors, and eliminates hours spent compiling and reconciling info from multiple sources.
Product regulatory compliance is further enhanced by the Regulatory Hub’s ability to plan audits that provide evidence of a quality process and that help companies respond faster and more efficiently to recalls. In addition, it simplifies adding required ECNs to units already in use.
There is no aspect of product regulatory compliance that is not simplified and streamlined by using the Regulatory Hub.
How the Regulatory Hub Works
Windchill includes both submission tracking data and regulatory tracking data. Using RESTful APIs, the system pulls product data from other applications as needed. For example, Windchill might pull information from the ThingWorx Material Compliance App—and this process works the same way for applications from third parties. The data is automatically formatted into the correct report and submitted electronically, and the system time-stamps the submission.
When the receiving agency acknowledges the submission, that data is also stored. This gives organizations a complete record of their timely submissions. At any point, the company has visibility into new, in progress, and completed submissions.
The Regulatory Hub is Flexible
Because the Regulatory Hub works across varying industries with different regulatory requirements, it is designed to be highly flexible and comprehensive. The built-in PLM compliance tools help companies document and follow a cohesive process for compliance and report submissions.
Users, such as a quality manager, can create or modify regulatory submissions as needed or when requirements change. The Regulatory Hub even includes a submission wizard that walks users through the entire process. As a result, there’s no need to wait for IT to create a custom report or train quality managers to be coders. This increases speed, accuracy, and efficiency across PLM compliance management.
Anyone can create a new submission report format—you don’t need to write code or wait for IT to do it.
Learn More About Windchill’s Regulatory Hub and PLM Compliance Management
If you’ve been struggling with the hassles of regulatory compliance, you will find the Regulatory Hub to be a revelation. Instead of using multiple systems with disparate and competing data, you’ll be able to:
- Eliminate delays related to IT developing custom reporting formats
- Reduce effort in reconciling data from multiple systems
- End the manual tracking of compliance reporting deadlines
- Gain better visibility into CAPA, ECNs, and service
- Ensure faster and more efficient recalls if necessary
To learn more about PLM compliance advantages, contact us today for a free, no-obligation demo or to ask any questions about how you can streamline your product regulatory compliance.