Products and Solutions

Closed-Loop PQM

Closed-Loop PQM

PQM

Closed-Loop PQM

Organizations need to assure product quality to their partners, regulators and customers. This requires a robust Quality Management Solution embedded within their Product Lifecycle Management (PLM) system. For Best-in Class companies, Quality is an integral part of the Design and Manufacturing processes and tools.

Pqm

What Is Quality Management?

Quality management makes sure products and processes meet high standards across the company, including external partners. It uses tools like FMEA (Failure Mode and Effects Analysis), CAPA (Corrective and Preventive Actions), and RCA (Root Cause Analysis) to quickly spot and fix issues. It’s essential for meeting regulations and industry standards. PTC integrates quality into PLM (Product Lifecycle Management), catching problems early to avoid costly last-minute fixes. 

pqm

Cutting the Cost of Poor Quality

To innovate quickly and stay compliant, teams need access to accurate, real-time data. PTC’s quality management tools help streamline development and connect teams. Automated processes improve decision-making, speed up CAPA resolutions, and reduce scrap and failures—leading to lower costs and happier customers. 

Pqm

Quality Through the Digital Thread

PTC’s Windchill platform brings together all parts of the business—from design to service—with built-in workflows and traceability. It connects quality processes (like audits, complaints, and risk analysis) directly to product data, helping companies deliver reliable, high-quality products faster. 

PLM Features

Key Features

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Change Management

Track and share updates across teams

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Document Control

Includes training tracking and compliance

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Closed-Loop Feedback

Use real-world data to improve designs

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Audit Tools

Monitor internal and supplier processes

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Design Data Visibility

Highlight critical-to-quality elements

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CAPAs & Non-Conformance

Automate issue tracking and resolution

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Customer Feedback Integration

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Digital Traceability

Supports key certifications and compliance standards

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Risk & Reliability Analysis

Including FMEA, fault tree analysis, Weibull forecasting

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Regulatory Support

Compliant with ISO, Six Sigma, FDA, and more

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Medical Device Ready

Built-in ISO 13485 processes

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IoT Connectivity

Monitor field performance remotely

Our Solution

To meet the growing expectations of partners, regulators, and customers, organizations must ensure consistent product quality. Achieving this requires a comprehensive quality management system integrated within their Product Lifecycle Management (PLM) framework. Many companies are now turning to ready-to-deploy Product Quality Management solutions that reflect proven industry practices and can be quickly adapted to scale with business growth. 

Recognizing this demand, Datafrond developed QLM-IN-A-BOX—a preconfigured, business-ready Quality Lifecycle Management (QLM) solution. Designed by PLM experts, this proprietary offering provides end-to-end product development best practices that align with ISO standards. QLM-IN-A-BOX is tailored specifically to help small and mid-size enterprises drive innovation while maintaining rigorous quality across all product-related processes. 

PLM-IN-A-BOX is a proprietary solution from Datafrond, designed by Datafrond PLM experts to help small and mid-size enterprises to respond to product innovation challenge by proactively focusing on product-related processes.

PLM-IN-A-BOX process, methodology and implementation frameworks are registered patents with USPTO (United States Patent and Trademark Office) assigned application number ‘13344601’, EFS ID ‘11772342’.

How it Works

Best Practices

Good Automated Manufacturing Practice (GAMP) Deploy solutions that adhere to GAMP Practices and ensure quality at each stage of the manufacturing process. Electronic systems for signoffs, record retention, and digital archiving of SOPs are vital for processes impacting product quality.   

01

Productivity

Real-time audits can be performed quickly. Analysis and evaluation are completed up to four times faster compared to traditional Excel-based solutions. 

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Risk Management

Provides risk management tools to help organizations quickly identify risks and lower overall value at risk (VAR). 

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Regulation Changes

Gives businesses of all sizes flexibility to adjust to shifting government policies and new regulations in expanding markets. 

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Oversight

Effective oversight of an organization’s assets and capabilities gives decision makers essential information for developing competitive strategies. 

Benefits

Solution Features

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Quality Event Management

Captures inspection data during material handling for integration into change notices and compliance audits. 

  • Track raw materials at the point of receipt eliminating non-conformance and compliance risks. 
  • Standard reporting templates by industry – ROHS, EPA, FDA, WEEE; better compliance control & deviation alerts. 
  • Closed loop engineering change and corrective action reporting that reduces time to audit and regulatory approvals

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Equipment & Assets Tracking

Offers centralized management for equipment and asset information, maintenance, safety, and manuals. 

  • Track and standardize company equipment to reduce deviations, improve consistency and increase six-sigma compliance 
  • Schedule maintenance alerts, record break downs, link to safety, operation manuals and trigger automatic noncompliance workflows prior to audit 
  • Trigger automatic preventive maintenance workflows, complete with replacement parts, manuals, compliance

01

SOP Documentation Control

Enables organizations to implement rigorous revision and change control procedures. It facilitates real-time approval tracking and audit capabilities, allowing seamless integration into the quality assurance process. 

  • Automated multilevel review and approval process using electronic signatures with the ability to generate water marked PDFs 
  • Generate audit reports on document approval status that create opportunities for process improvements 
  • Systematically categorize and version control a range of quality artifacts, including design standards, procedures, and guides, to enhance productivity and facilitate effective information reuse.

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Compliance & Training

The integrated solution enables firms to audit and manage employee training and incorporate it into the quality assurance process. 

  • Manage end-to-end employee training process from new hire through exit 
  • Track and manage employee training course work and records providing a holistic view of human capital assets for a better understanding, utilization and leveraging employee know-how 
  • Electronic signature approvals for employee course work that provide holistic view of information across multiple systems

Contact a PQM Expert

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