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Solving Compliance & Data Management Challenges in the Aerospace & Defense Industry

In aerospace, compliance, interview, Q&A by Alicia CheungLeave a Comment

This is an excerpt from an interview Generis Group did with Assent Compliance prior to the American Aerospace & Defense Summit 2018. “What are some of the biggest regulatory and compliance challenges aerospace and defense companies face? The “Once an Article, Always an Article” ruling under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation has had a significant impact on aerospace and defense companies. They must now evaluate their products for substances of very high concern (SVHCs) under the regulation. Many parts produced by industry manufacturers are complex, containing several subparts and undergoing a range of processes that could potentially introduce restricted chemicals to the end product. Each of these must be evaluated individually in accordance with the article interpretation. The list of chemicals restricted under REACH is also growing considerably and will continue to do so over the coming years. Companies must manage business continuity risk as more SVHCs are restricted, denying them access to substances that are critical to the ongoing maintenance and repair of their products. Companies must also manage a range of emerging human rights legislation that requires them to show year-over-year due diligence efforts to mitigate the risk of human rights violations in their supply chains. Key markets that have introduced disclosure requirements include the U.S., the UK, France and Australia. Additionally, the industry is threatened by a rapidly shifting trade landscape that includes fluctuating tariffs, sanctions, and free trade agreements.”

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Reduce Supplier Risk, Reduce Organizational Risk

In compliance, medical device, medtech, quality, regulations by Alicia Cheung1 Comment

Risk is a major focus in most businesses today, regardless of industry. In the past few years, the Life Sciences have seen a steady rise in supply chain issues resulting in lost market caps, recalls, regulatory fines, and other financial impacts valued in the billions of dollars. The Medical Device Industry is no exception to this reality; if the industry wants to improve patient outcomes, then it has to manage risk. According to Pilgrim Quality Solutions, one of the largest sources of organizational risk is dependence on third-party suppliers. Today’s global economy has added complexity to supply chains, and longer supply chains are making it increasingly difficult to manage suppliers, and in many cases, suppliers’ suppliers, thereby increasing overall risk. The plethora of regulatory requirements placed on Medical Device organizations, including the updates to ISO 13485:2016, reflect this new reality.

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Track and Trace: A Step-by-Step Guide to Implementing An Effective Program

In compliance, pharmaceutical, regulations by Alicia CheungLeave a Comment

Although the universal standard for pharmaceutical track-and-trace solutions has yet to emerge, the California Board of Pharmacy’s ePedigree requirements are currently driving action in efforts toward implementing serialization to provide supply chain integrity to the public. While several states are actively pursuing similar legislation, California’s pending requirements are the most demanding since they track product to the smallest saleable unit level. Enforcement of the ePedigree legislation, combined with the accelerated pace of regulatory involvement worldwide in serialization and track-and-trace means that it is now vital for the industry to accelerate its efforts to put compliance measures in place.

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How to Avoid Data Integrity Disasters in Your Manufacturing Network

In cGMP, compliance, pharmaceutical, risk management by Alicia Cheung1 Comment

Lachman Consultants says that pharmaceutical manufacturers can establish a competitive advantage by preventing questions about their product quality data from disrupting current and future revenue. In recent years, data integrity shortcomings identified during GMP inspections have cost firms dearly. In some cases, the financial impact has run into the hundreds of millions of dollars. Despite the risk, many manufacturers do not seek help with data integrity compliance until there is a problem. By then, it may be too late to avoid an impact on profitability. For this reason, Lachman Consultants urges pharmaceutical companies to establish a competitive advantage by taking a proactive approach to data integrity assurance.

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Global Regulatory Intelligence: Evaluating the Developments to the EU MDR

In compliance, medical device, regulations by Cressida MurrayLeave a Comment

Is your company prepared for the new EU MDR? Michael Santalucia, Vice President of Global Regulatory Affairs for Terumo BCT, is responsible for managing the global regulatory affairs function regarding the development and execution of product submission strategies for the company’s medical devices, regulatory compliance requirements, and industry advocacy. As medical device companies face large regulatory challenges to comply with the new European Union Medical Device Regulation (EU MDR), we sat down with Michael Santalucia to learn how Regulatory Affairs organizations are evolving along with global regulations, what Terumo BCT has been doing to comply with EU MDR, and how members of the medical device industry can stay informed. “The EU MDR is arguably the most important legislation to affect our industry in the last two decades. Because of the impact this will have for any firm with CE marked devices, it is essential to have someone in the organization that can provide the company with advice and guidance to the requirements that have been established and those that are yet to evolve.”

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In the Global Life Sciences Market, What You Don’t Know CAN Hurt You

In compliance, pharmaceutical, regulations, risk management by Cressida MurrayLeave a Comment

The global life sciences market is witnessing an unprecedented pace of change across pharmaceuticals, medical devices, and biologics. It’s the new normal as trends like big data, the Internet of Things, increasing supply chain complexity and the advance of biosimilars create new opportunities – and challenges – for life sciences companies. As regulators around the globe scramble to stay abreast of these trends, they are making important and often major updates to directives. Quite often these directives are not coordinated between markets, creating a patchwork compliance landscape to be navigated. If you are involved in your company’s quality, regulatory surveillance, compliance, or knowledge management efforts, the following questions are for you: Do you have frequent (i.e. at least monthly) conversations with the regulators in the markets where you manufacture AND sell? Does your company have the expertise to predict and interpret regulatory directives? Do you have reliable methods of disseminating information on the impact of regulatory directives to your clinical operations teams? How does your organization remain aware of and respond to GxP actions, import alerts, or other market actions against other companies in your industry?

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Benchmarks and Best Practices for Next-Generation QMS

In automation, biomanufacturing, biotechnology, compliance, global quality system, medical device, pharmaceutical, QMS, quality, Quality Management System by Alicia CheungLeave a Comment

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.

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Cognition Ebook: Safety By Design

In compliance, design, healthcare technology, Life sciences, medical device, medtech by Harshini SrikanthanLeave a Comment

Cognition’s latest ebook “Safety by Design: Guided compliance for risk reduction in medical device production and commercialization,” explores how to mitigate risk during the device developmental process. The ebook looks at pressing topics such as understanding the challenges that surround the meeting requirements of the FDA and other regulatory bodies, FDA’s position on risk reduction and automatic traceability. When submitting for regulatory approval, companies need to demonstrate that they have used a well-defined, documented design control and risk management process in place, along with evidence that they are following it. Cognition’s Cockpit Platform provides templates that are configurable to meet common standards and regulations. To access the full ebook, click here.

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Whitepaper: Smart Quality Management, Industry 4.0 and Quality Management Systems

In compliance, Industry 4.0, medical device, medtech, Quality by design, Quality Management System, Smart Factory by Cressida MurrayLeave a Comment

In order to remain competitive in the rapidly-evolving Industry 4.0 landscape, most companies will be required to make technological changes. In the medical device industry, there are a number of unique considerations this technological change presents. This whitepaper, written by Pilgrim Quality Solutions and produced by Generis, explores the impact Industry 4.0 will have on the medical device industry, and how to make the shift to ‘Quality 4.0’. It explores areas where medical device manufacturers should focus investment; the impact on product validation and regulatory and quality compliance; and how Quality Leaders can embed operational quality into risk processes that are outside of traditional QMS. View the whitepaper to explore: Industry 4.0 – What is Industry 4.0 and What is Driving it – The Smart Factory, Cyberphysical Systems, and the Internet of Things – Effect on Products and Processes Implications for the Medical Device Industry – Focus on Digital Technologies – Data Security – Investing in Change Impact on Validation, Regulatory & Quality Compliance – Validating Smart Products – FDA Guidance – Understanding the Quality Impact of the Smart Factory – Embedding Quality in the Value Chain How to Move Toward Smart Quality Management – The Need for Automated, Operational Quality Risk Management – How Quality Leaders Can Gain Organizational Support for Quality 4.0 Initiatives – Quality 4.0 Investments to Support Industry 4.0 – Strategic Objectives   Smart Quality Management, Industry 4.0 and Quality Management Systems

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