Products and Solutions

Closed-Loop PQM

Closed-Loop PQM

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. 

01

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

01

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

01

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.

01

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

PQM

WINDCHILL CLOSED-LOOP PRODUCT QUALITY MANAGEMENT FOR THE MEDICAL DEVICE INDUSTRY

Coordinate engineering, quality, and regulatory teams through a shared, product-focused perspective of the medical innovation cycle.

Adopt best practices for Design and Document Control as an integral part of your product lifecycle.

Improve quality with integral Risk, CAPA, Nonconformance and Complaint management.

Start quickly with easy SAAS setup and fast software validation.

Contact a PQM Expert

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