Case Studies Achieving Closed-Loop Design Control Across the Organization

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	Achieving Closed-Loop Design Control Across the Organization

Achieving Closed-Loop Design Control Across the Organization

Technology Category	Application Infrastructure & Middleware - Data Visualization Functional Applications - Enterprise Resource Planning Systems (ERP) Functional Applications - Product Lifecycle Management Systems (PLM)
Applicable Industries	Healthcare & Hospitals Life Sciences
Applicable Functions	Product Research & Development Quality Assurance
Use Cases	Predictive Maintenance Regulatory Compliance Monitoring Remote Collaboration
Services	System Integration Training
Challenge	When evaluating solutions, Pulse Biosciences knew what they needed—one place for all product lifecycle and quality management processes. Guneet Bhogal, Quality Assurance Specialist, shares, “We wanted to have a closed-loop system with everyone collaboratively working on the same current product definition, through the same processes, to the same goals.” For medical device companies like Pulse Biosciences, predictability and consistency are not only good, but critical. Prior to implementing Arena, Pulse Biosciences’ product processes were paper-based, and the team expended extensive efforts to track everything manually and ensure compliance. Read More
About Customer	Pulse Biosciences is a company that is pioneering a novel and proprietary platform technology called Nano-Pulse Stimulation (NPS). This technology uses nanosecond pulsed electric fields to induce cancer cells in tumors to die naturally by triggering the adaptive immune system response. The company is focused on providing drug-free treatments for some cancers, thereby reducing toxicology. To achieve this mission, Pulse Biosciences relies on Arena to manage all aspects of quality management processes, from BOM creation to design controls, device history file (DHF), records keeping, and training management. Read More
Solution	Pulse Biosciences implemented Arena’s full suite of solutions to manage their quality and product lifecycle processes. Arena helps with DHF, project management, supplier management, CAPA, and all quality actions like NCMRs and change control. The system also manages training, ensuring compliance and traceability. Collaboration and access anytime around the world are crucial for Pulse Biosciences, especially when team members are performing clinical trials or on vacation. Arena provides the necessary security and tracking for urgent changes, regardless of location. All employees, from the CEO to engineers to the clinical team, use Arena. The company also uses Arena Analytics dashboards for management review boards to track progress and identify areas for improvement. Read More Log in to view content
Contents

Technology Category

Application Infrastructure & Middleware - Data Visualization

Functional Applications - Enterprise Resource Planning Systems (ERP)

Functional Applications - Product Lifecycle Management Systems (PLM)

Applicable Industries

Healthcare & Hospitals

Life Sciences

Applicable Functions

Product Research & Development

Quality Assurance

Use Cases

Predictive Maintenance

Regulatory Compliance Monitoring

Remote Collaboration

Services

System Integration

Training

Challenge

When evaluating solutions, Pulse Biosciences knew what they needed—one place for all product lifecycle and quality management processes. Guneet Bhogal, Quality Assurance Specialist, shares, “We wanted to have a closed-loop system with everyone collaboratively working on the same current product definition, through the same processes, to the same goals.” For medical device companies like Pulse Biosciences, predictability and consistency are not only good, but critical. Prior to implementing Arena, Pulse Biosciences’ product processes were paper-based, and the team expended extensive efforts to track everything manually and ensure compliance.

About Customer

Pulse Biosciences is a company that is pioneering a novel and proprietary platform technology called Nano-Pulse Stimulation (NPS). This technology uses nanosecond pulsed electric fields to induce cancer cells in tumors to die naturally by triggering the adaptive immune system response. The company is focused on providing drug-free treatments for some cancers, thereby reducing toxicology. To achieve this mission, Pulse Biosciences relies on Arena to manage all aspects of quality management processes, from BOM creation to design controls, device history file (DHF), records keeping, and training management.

Solution

Pulse Biosciences implemented Arena’s full suite of solutions to manage their quality and product lifecycle processes. Arena helps with DHF, project management, supplier management, CAPA, and all quality actions like NCMRs and change control. The system also manages training, ensuring compliance and traceability. Collaboration and access anytime around the world are crucial for Pulse Biosciences, especially when team members are performing clinical trials or on vacation. Arena provides the necessary security and tracking for urgent changes, regardless of location. All employees, from the CEO to engineers to the clinical team, use Arena. The company also uses Arena Analytics dashboards for management review boards to track progress and identify areas for improvement.

Impact #1	Arena has enabled Pulse Biosciences to transition from paper-based processes to a digital system, significantly reducing manual tracking efforts.
Impact #2	The system supports global collaboration, allowing team members to access and manage urgent changes securely from anywhere in the world.
Impact #3	Arena has improved compliance and audit readiness, with auditors appreciating the control and structure provided by the system.

Impact #1

Arena has enabled Pulse Biosciences to transition from paper-based processes to a digital system, significantly reducing manual tracking efforts.

Impact #2

The system supports global collaboration, allowing team members to access and manage urgent changes securely from anywhere in the world.

Impact #3

Arena has improved compliance and audit readiness, with auditors appreciating the control and structure provided by the system.

Benefit #1	Training compliance improved to 97%+.
Benefit #2	Enhanced traceability and analytics capabilities.
Benefit #3	Improved training management and compliance.

Benefit #1

Training compliance improved to 97%+.

Benefit #2

Enhanced traceability and analytics capabilities.

Benefit #3

Improved training management and compliance.

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Overview

Achieving Closed-Loop Design Control Across the Organization

Operational Impact

Quantitative Benefit