Q&A with NTS Unitek Prior to the American Aerospace & Defense Summit 2018, we spoke to NTS Unitek to discuss how to maximize supplier quality with limited resources. In this Q&A, we discuss best practices to strengthen a supplier quality management program, how A&D companies can ensure product quality and what strategies A&D companies can employ to streamline their inspections and audits. This is an excerpt from the Q&A Generis did with NTS Unitek:
Read More →De-Risking in the MedTech Industry
Risk analysis is an essential component of your quality management system. A mandatory task for every new medical device about to hit the market is creating an appropriate Risk Management Plan as required by ISO 14971, the international standard for applying risk management to the design and manufacture of medical devices.
Read More →EQMS and Quality 4.0: Build a Successful Quality Strategy for a Life Science Company
Quality is a critical concern in life science manufacturing industries, and leaders across life science companies have many quality and compliance considerations. However, few of those concerns have the strategic impact that Quality 4.0 does. Quality 4.0 is the digitalization of quality management through the application of traditional and Industry 4.0 technologies to improve quality monitoring and outcomes. At its core, Quality 4.0 is the digital continuum of quality data combined with other data from sources such as manufacturing, machine sensors, supplier management, and in-service across a product’s life, new analytical insights derived from that data, and the organization-wide transparent consumption of insights.
Read More →Why You Need a New Quality Management System
With technology rapidly changing, a global market, and competition around every corner, quality is one of the most important factors in manufacturing. Quality in products and process will ultimately keep any organization relevant in today’s marketplace. Additionally, having an efficient, paperless, and compliant QMS System can give an organization a competitive advantage.
Read More →How to Build Your Quality Nirvana: Q&A with Kari Miller of Pilgrim QMS
Quality management is an integral factor in the development, approval, and commercialization of medical devices. With the American Medical Device Summit approaching, we took a moment to sit down with one of the summit presenters, Kari Miller, Vice President of Regulatory and Product Management at Pilgrim Quality Solutions, to gather her insights on the challenges and opportunities in quality management and explore some best practices to create a Quality Nirvana. As Vice President of Regulatory and Product Management, Kari Miller is responsible for driving strategic product direction and delivery of industry best practice solutions to Pilgrim’s customer base. Working with customers, industry analysts, and regulators, as well as Pilgrim’s Development, Professional Services, and Support groups, Kari and her team are responsible for translating market and industry trends, along with customer and regulatory requirements, into industry-leading enterprise quality management solutions that meet the needs of the heavily regulated Life Sciences market. Additionally, Kari leads the development of user documentation and solution presentations. Working with Pilgrim’s Customer Product Advisory Board, Kari is responsible for the company’s product roadmap, product partner relationships, and overall product direction.
Read More →Quality Management in the Board Room
Building the Executive Business Case for EQMS According to Pilgrim, quality leaders today are facing new challenges and opportunities presented by changing global markets, disruptive technologies, new regulations, and social media. Their quality management maturity has not increased quickly enough to keep pace, largely due to chronic underinvestment. When done right, quality extends throughout the enterprise and provides unique value across all functions. However, quality is stuck in a catch-22. It must break out of the silo to achieve its potential value, but the lack of perceived value reduces support from other leaders and top executives. Support from top executives plays a crucial role in the long-term effectiveness of quality. Three elements that quality needs to thrive: Top-down support Executive voice Sustained resources
Read More →Benchmarks and Best Practices for Next-Generation QMS
In a recent study conducted for Pilgrim, quality and compliance professionals from the top 2,000 Pharmaceutical, BioTech, Medical Device, and Combination Product companies were surveyed on the “state of the state” of the business, regulatory, and technology landscape of their current quality management systems (QMS). This research provides fresh insights into the state of quality and compliance management in the Life Sciences industry, as well as quantitative data which demonstrates that many Life Sciences companies are preparing for or embracing Next-Generation Quality Management practices.
Read More →GDP for APIs New Regulations
The Shift to Monitoring BioPharma Product Quality Throughout Their Lifecycle For years, pharmaceutical manufacturers have talked about the last mile. With mail order pharmacies, direct to pharmacy/patient channels, and things like orphan drug clinical trials, the last mile can be complex yet largely unregulated. The other end of the pharmaceutical supply chain, the inbound supply of ingredients, has received more solid guidance from regulators. In 2000, major markets including the EU and US supported the ICH Q7 initiative by publishing their own guidelines specifically for GMP for APIs. Although GMP guides have included some elements on storage and distribution, the only GDP focused guide was the WHO Guide on GTDP for Pharmaceutical Starting Materials until recently.
Read More →Supplier Quality Management: SQM’s Rightful Role in Your Enterprise
While there are many ways to define quality, the most important definition of quality is from the customer’s perspective – perceived quality – as this impacts brand loyalty, revenue, market share, and margins. When customers directly engage with a product, they consciously and subconsciously compare it to previous experiences with similar and dissimilar products. Indirect experiences also influence perceived quality, such as by brand image and social media.
Read More →The Quality 4.0 Impact and Strategy Handbook
The most recent decade has seen rapid advances in connectivity, mobility, analytics, scalability, and data, spawning what has been called the fourth industrial revolution, or Industry 4.0. This fourth industrial revolution has digitalized operations and resulted in transformations in manufacturing efficiency, supply chain performance, product innovation, and in some cases enabled entirely new business models. This transformation should be top of mind for quality leaders, as quality improvement and monitoring are among the top use cases for Industry 4.0. Quality 4.0 is closely aligning quality management with Industry 4.0 to enable enterprise efficiencies, performance, innovation and business models. However, much of the market isn’t focusing on Quality 4.0, since many quality teams are still trying to solve yesterday’s problems: inefficiency caused by fragmented systems, manual metrics calculations, quality teams independently performing quality work with minimal cross-functional ownership, and ineffective supplier communication, among others.
Read More →