• 2019-bl-thumb-manufacturing-batch-records-pains-v2

    EBR: Good for What Ails Your Batch Record Process

    Let’s face it, winter is a euphemism for cold and flu season. Much like these inconvenient and disruptive viral infections wreak havoc on the human body, paper-based batch record processes can infect a manufacturing floor, slowing and compromising an otherwise healthy operation. Fortunately, an electronic batch record (EBR) solution can cure the disease.

    Full story
  • 2019-bl-thumb-wellington-foods-logo

    Executive Perspective: Why Paperless Batch Records Make (Dollars and) Sense for Wellington Foods

    Manufacturers across all industries continue to implement and expand their digital transformation strategies, and as a result, the presence of paper on the factory floor is in decline. But one critical production process is proving to be more dependent on paper than others – at least until now. With the help of an innovative new solution, contract manufacturer Wellington Foods is one of the first companies to fully digitize its batch record process, and it’s already reaping the benefits.

    Full story
  • 2019-bl-thumb-seeking-simultaneous-regulatory-approval

    Simultaneous US/EU Regulatory Approval: How Timing Could Be a Factor

    Regulated companies seek every opportunity to get products on the global market faster, even pursuing simultaneous regulatory approval in two of the largest global markets – the United States (U.S.) and the European Union (EU). However, governing entities in both regions are embarking on changes that could disrupt this strategy.

    Full story
  • 2018-bl-thumb-regulatory-barriers-for-biotech-medtech-startups-europe

    2019 Med Device Trends to Watch For: Regulatory Changes

    For the medtech industry, 2019 is going to be marked by a slew of regulatory changes, beginning with Canada’s requirement of Medical Device Single Audit Program (MDSAP), which took effect on Jan. 1.

    Full story
  • 2019-bl-thumb-top-manufacturing-edhr-trends

    4 Tech Trends to Watch in Manufacturing Device History Records

    As medical device manufacturers try to understand exactly how and where to use constantly evolving digital technologies to achieve better operational and quality results, they must keep a close eye on changes in automation and be agile to respond to these developments. Explore four trends the med device industry can expect in 2019 and beyond, particularly as they relate to manufacturers’ device history records (DHRs).

    Full story
  • 2019-bl-thumb-top-pharma-trends-of-2019

    3 Trends Shaping the Pharma Industry in 2019

    Pharmaceutical companies are continually hunting for innovations that might give them an advantage in an increasingly competitive and profitable market. This article takes a deep dive into the transformational effects that trends like AI, medical marijuana and cloud technologies are having on the pharma industry.

    Full story
  • business-icons-digital-touchboard-132

    Regulatory Changes Top the List of 2019 Med Device Trends to Watch For

    If you belong to the medical device industry, a perfect storm of regulatory changes is heading your way. The changes in Canada and Europe are at the top of a list of developments and trends to watch for this year, according to four medical device experts.

    Full story
  • 2019-bl-thumb-digitally-transform-the-supply-chain

    5 Ways to Digitally Transform Your Supply Chain

    Advances in digital tools and technologies promise to improve supply chain performance and help usher in the next-generation digital supply chain, Supply Chain 4.0. For global life science companies, this digital revolution has enormous implications for the supply chain.

    Full story
  • 2019-bl-thumb-manufacturing-recall-blunders

    Recall Blunders: How to Avoid Them and How to Recover

    Even the slightest oversights or errors can lead to product recalls. Learn about the primary causes of recalls, how regulators classify recalls, the four critical steps of recall recovery, and strategies that can help you avoid recalls altogether.

    Full story
  • 2019-bl-thumb-using-sherlock-holmes-to-pick-a-consultant

    Using Sherlock Holmes to Pick a Consultant

    When you’re faced with a daunting task, it can be tempting to bring in a consultant to deal with it. Depending on the circumstances, this can be a great idea or a disaster. Fortunately, there are a few lessons from the world’s only consulting detective that can help you make this decision.

    Full story
  • 2019-bl-thumb-costs-of-paper-hard-vs-soft-roi

    Costs of Paper: Hard vs. Soft ROI

    Though we’re well into the 21st century, document control in the life science and health care sectors remains largely a paper-based system. Learn from a seasoned professional who worked for the U.S. Food and Drug Administration (FDA) and the U.S. Department of Veterans Affairs how going digital can significantly reduce risk while simultaneously provide you with both soft and hard ROI.

    Full story
  • 2020-bl-manufacturing-excellence-04_132x132

    4 Common Pains in Managing Device History Records

    In medical device and diagnostic manufacturing, companies must keep a complete and accurate record of each product they produce in the form of a device history record (DHR). The DHR is literally the history of the device, and manufacturers in the business of medical technology face common challenges when using a paper-based or partially electronic system.

    Full story
  • 2018-bl-thumb-manufacturing-and-cannabis-laws

    Rolling the Dice on Cannabis Manufacturing

    Cannabis is complicated, with constantly changing legalities surrounding the industry. Companies wanting to enter this market might find the financial forecasts appealing, but they should also be aware of and prepared for the risks of this unique industry.

    Full story
  • ukraine-mountain-landscapes-132

    How Sustainable Manufacturing Can Help the Environment and Your ROI

    Sustainable manufacturing is no longer just a buzzword that looks good in your company’s annual report. Technology has advanced to the point where implementing sustainable manufacturing best practices can reduce waste and energy use while still delivering the quality, cost-effective products your customers want.

    Full story
  • blue-operation-table-with-nurse-132

    4 Tips to Improve Your Medical Device Regulatory Submissions

    Regulatory affairs (RA) professionals in the medical device industry essentially want the same thing: to improve their submissions worldwide for a faster time to market. Alex Butler, an industry veteran, has two words for his peers — global approach. He shares some tips for achieving an effective global strategy.

    Full story
  • white-empty-warehouse-132

    Call and Response: RFPs and Vendor Proposals

    In Part 2 of a pair of articles on pharma companies having a better and more effective vendor selection experience, it’s clear that a thorough request for proposal (RFP) and well-defined vendor selection SOP are essential. By controlling the vendor selection information, you can control the process and negotiate the best deal.

    Full story
  • 2018-bl-thumb-modernizing-manufacturing-digital-trends-january

    Modernizing Manufacturing With Digital Trends

    Stagnation is the enemy of most businesses in most industries, making it hard to keep up – especially when it comes to technology. Managers starting to modernize their manufacturing floor should consider how to use that technology to make more products available more quickly with more advancements.

    Full story
  • warehouse-logististics-icons-132

    Despite a Focus on Risk Management, Why Do Unthinkable Things Continue to Happen?

    Accidents and errors, in life and in manufacturing more specifically, continue to happen despite heightened levels of risk management and international standards. Find out why time, frequency and probability can’t be factored in to calculate likelihood and learn the key to determining actual risk.

    Full story
  • smart-document-contract-132

    5 Keys to Helping Your Device Company Gain MDSAP Certification

    The Medical Device Single Audit Program (MDSAP) can help give your medtech company an edge in international markets. In Part 3 of this three-part series, find out how to most seamlessly navigate your company through the MDSAP audit process.

    Full story
  • 2018-bl-thumb-modernizing

    Modernizing the FDA’s 510(k) Review Process: Pros, Cons and the Twilight Zone, Part 3

    This is the last article of a three-part series on the need to modernize the FDA’s 510(k) program. This blog post explains why using the strictest standard as the foundation for your submissions worldwide, even in countries that are relatively lenient, is the right thing to do in terms of both ethics and economics.

    Full story
[ { "key": "fid#1", "value": ["GxP Lifeline Blog"] } ]