E-BOOKS &
WHITE PAPERS

Gain Insights to Improve Your
Product and Quality Processes

Audit Resilience in a Virtual World: A Practical Guide

Audit resilience means being able to provide evidence that your company follows compliant practices. Challenges include regulations that vary year to year or across geographies. When suppliers are key to your product development and release, you need them to comply as well. Building disciplined processes with audit awareness from the beginning will ensure you have the practices, data, and people to ensure success in on-site and remote audits. In this e-book, we share ideas on how to prepare for audits so that you can demonstrate you follow compliant practices.

Getting to Milestones in a Virtual World: A Practical Guide For Product Work

Getting products to market can involve multiple teams, various stakeholders, a network of partners and suppliers, and thousands of hours of work. In addition, economic and political disruptions, unanticipated industry shifts, or a move to remote-based work can pose threats to your new product development (NPD) and new product introduction (NPI) timeline. In this e-book, we share ideas based on real-world insights to effectively manage product development processes to reach your product milestone goals.

MORE THAN A PRODUCT: INNOVATION FOR A NEW ERA

Advances in digitalization, artificial intelligence and the Internet of Things (IoT) are connecting products to people in new ways. Apps, sensors, and social platforms are integrating products and customer ecosystems. This report is based on a series of interviews with senior leaders at six leading-edge organizations in healthcare, consumer electronics, and autonomous vehicle technologies. Read this report to see how new technologies are changing the face of product innovation.

How Cloud Solutions Accelerate ROI

Capturing the business benefits of Cloud PLM and QMS: In this white paper, we explore the benefits of cloud software systems aimed at helping companies design and deliver high-quality products. In particular, we look at the benefits and ROI for cloud-based product lifecycle management (PLM) and quality management system (QMS) solutions. Both solutions provide companies with the necessary product and quality record control needed to effectively convert ideas to products in these challenging times.

breaking down barriers to product innovation

Connecting product information and teams Is vital to success during new product development (NPD) and new product introduction (NPI). As companies pick up the pace of innovation to meet customer demand, they need to reduce costs and ensure regulatory compliance to stay ahead of increased global competition. In this white paper, we explain how to accelerate your product launch processes with cloud-based PLM and QMS solutions.

7 principles of product-centric QUALITY MANAGEMENT

For medical device companies, having a rock-solid approach to quality is a prerequisite for success and innovation. The burden on quality and operations leaders to introduce compliant and innovative medical devices to market is great. And as regulatory standards, new market requirements, and device complexities evolve, so does the weight of the burdens these leaders face. Read this eBook to learn how to overcome process delays, compliance risks, and barriers that impede innovation.

intelligent bom management for today’s product innovators

The rapid evolution of technology and outsourced manufacturing has created new opportunities, but also new challenges and risks. You don't have to look very far to see how poor product design and development can impact your company and customers. Working with dispersed teams and supply chain partners requires collaboration around the latest bill of materials (BOM) to reduce production errors and shipping delays. Read how Arena provides a more intelligent way to control, share, and release accurate BOMs.

Rethinking the Supply Chain: Staying Connected in Times of Uncertainty

To continually prepare for supply chain disruptions, you need to continually evolve. Newer technologies like the Internet of Things (IoT), cloud and edge computing, and advanced data analytics are creating new opportunities. Sharing information efficiently with your supply chain partners ensures the fast delivery of high-quality products. Improving collaboration during new product development and introduction enables dispersed teams to optimize product launches and overcome supply chain shocks.

Secure itar and ear product development in the cloud

The defense and aerospace market beckons to many product companies seeking to diversify, but also demands regulatory compliance in addition to the quality, product development efficiency, and technological innovations customers expect. Many product design and manufacturing companies in this market provide products subject to export regulations, including International Traffic in Arms Regulations (ITAR) and Export Administration Regulations (EAR), requiring compliance in technical data handling and access.

Autonomous, Connected & Interactive: The Next Wave of Product Innovation

As products continue to get smarter and more connected, they also become more complex with mechanical, electrical, and software components interacting in more sophisticated ways. We explore how new technologies are advancing product development and what's possible. Read this brief to learn how leading-edge companies are redefining the next wave of product innovation.

HOW STRONG DESIGN CONTROLS SIMPLIFY COMPLIANCE AND ELIMINATE AUDIT ANXIETY

Achieving and maintaining regulatory compliance is an imposing hurdle for many medical device manufacturers. Missteps and inefficiencies addressing FDA, ISO, and other regulatory directives can result in costly delays, warning letters, and business closure. Today’s manufacturers must establish proper design controls to demonstrate devices are safe and effective for their intended uses. Read this white paper to see how product-centric QMS enables better design controls.

Is Your Part Numbering Scheme Costing You Millions?

Today’s manufacturers must create, manage, and track thousands of parts throughout the new product development (NPD) process. According to an independent study by EMA Design Automation, every time a new part is added to a company’s library, it can cost thousands of dollars to qualify, design, and roll out. That's why choosing the right part numbering scheme to reference your parts is critical to your success. Read how part numbering best-practices can help you avoid costly mistakes.

FDA SOFTWARE VALIDATION: HOW CLOUD QMS REDUCES COSTS AND RESOURCE DRAIN

Medical device companies must overcome many hurdles to get safe, high-quality products to market. Establishing and maintaining an effective quality management system (QMS) to satisfy both the FDA and ISO is critical. And, when the system is software-based, the manufacturer must also demonstrate and provide evidence or validate that it meets the requirements to consistently deliver safe, high-quality devices to market. Read this white paper to see how Cloud QMS simplifies software validation.

PLM vs. PDM: Why Product Lifecycle Management is Required Today

Connected technologies have changed product development dramatically. Fewer products involve mechanical-only designs as companies try to leverage many new technologies aimed at connecting people, data, and products. As more products are built with sensors, software, and electronics, all designs—not just mechanical ones—must interact seamlessly. Global design and supply chain partners must collaborate in real time to maintain a competitive edge in the quest to deliver innovative products to market rapidly.

Meeting Regulatory Compliance Requirements in Today’s Global Market

Medical device manufacturers and their supply chains must get their products to market quickly, while facing new technological challenges, global competition, and the need to mitigate risks. Medical devices introduce even more challenges as companies strive to navigate the ever-evolving regulatory landscape including FDA 21 CFR Part 11 and Part 820, ISO 13485, and environmental compliance regulations. Read how a product-centric quality management system (QMS) enables traceability and continuous improvement.

Engineering Change Management: Three Challenges, Five Fixes

The lifeblood for getting new products to market, or improving existing ones, is engineering change management. Streamlining processes enables dispersed teams to create, review, and approve new or existing designs faster. Engineering, quality, purchasing, manufacturing, and supply chain partners must be able to work together seamlessly to design, develop, test, build, and ship high-quality products to customers effectively. Learn how to overcome key challenges in this white paper.

Product-Centric QMS: A Critical Advantage for Regulated Companies

Quality systems for companies regulated by the FDA must follow current good manufacturing practices to comply with 21 CFR part 820 regulations. Medical device companies must also adhere to ISO 13485 and demonstrate their ability to meet customer and regulatory requirements. Until recently, you could choose only one type of quality management system (QMS) to simplify compliance. Arena’s product-centric QMS enables you to optimize quality management in the context of managing the entire product record.

Secrets to Success in the Hot IoT Space

Many high-tech electronics and medical device companies are developing smart devices leveraging the Internet of Things (IoT). These connected devices have more electronics, sensors, and software that require design teams to work together throughout the product lifecycle to ensure interoperability. Arena Solutions provides a single source of product design truth to keep dispersed teams and supply chains on the same page, and speed new product development (NPD) and new product introduction (NPI).