Showing items tagged as Document Control

  • 2021-bl-5-compliance-mistakes_132x132

    5 Common Compliance Problems and How to Avoid Them

    Five of the most common compliance problems and how to avoid them including documentation issues, lack of quality oversight, neglecting to assess risks, not learning from mistakes, and failure to follow through on commitments.

    Full story
  • 2020-bl-using-connected-quality_132x132

    What Connected Quality Means for Training

    For regulated companies, there’s a lot riding on training. If someone isn’t trained, the life-saving products of life sciences companies can become life-ending products. An integrated training management system gives training managers a complete picture of what’s going on with training and what they need to do next to stay on track.

    Full story
  • 2020-bl-connected-quality-avoid-bottlenecks_132x132

    Give Thanks for Better Document Control

    There are multiple things that make Thanksgiving stressful. Relatives and food immediately come to mind. The level of orchestration required to pull off a successful Thanksgiving dinner is ridiculous. While we can’t make it easier to manage a successful Thanksgiving, there are ways to simplify your document management using artificial intelligence (AI) and advanced analytics.

    Full story
  • 2020-bl-thumb-document-control-system_132x132

    Chronicles of a Document Control System

    Regulated companies are often reminded that if it isn’t documented, it didn’t happen. It’s also safe to say if it is documented, but the documents can’t be found, it didn’t happen. An efficient document control system is at the core of quality management and good manufacturing practices.

    Full story
  • 2020-bl-thumb-repost-dcs-and-eqms

    Quality Control, Quality Assurance and the EQMS That Improves Both

    Quality is an important part of doing business in regulatory environments. However, the differences between quality assurance and quality control can be hard to pin down. Learn how both play into quality management and how an enterprise quality management system simplifies them.

    Full story
  • 2019-bl-thumb-going-green-packaging-nutraceuticals-trends

    Top 5 Nutraceutical Trends: Going Green With Packaging

    Plastic is the new GMO. It’s experiencing similar ostracization due to the large amounts of plastic produced each year that winds up in landfills and in the ocean. Moving away from a plastic dependency requires nutraceutical companies to be prepared with innovative ideas and a manufacturing process that is easily adaptable.

    Full story
  • 2019-nl-bl-thumb-refresh-cost-of-paper

    Life Sciences Companies Can Achieve Greater ROI by Digitizing Their Data

    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 providing you with both greater soft and hard ROI.

    Full story
  • 2019-bl-thumb-fda-warning-letters

    Prelude to an FDA Warning Letter

    Receiving an FDA warning letter usually sets off a chain reaction of required responses, follow-up tasks and additional correspondence that effectively keeps a regulated company from getting product out the door. This article discusses some of the common reasons life sciences companies receive warning letters and provides tips on how to avoid receiving one.

    Full story
  • 2017-bl-thumb-what-is-doc-control-system

    How Digital Document Control Boosts Manufacturing Efficiency

    Regulated companies are often reminded that if it isn’t documented, it didn’t happen. It’s also safe to say if it is documented, but the documents can’t be found, it didn’t happen. Efficient document control is at the core of quality management, compliance and getting products out the door.

    Full story
  • 2019-bl-thumb-war-on-paper-arbor-day

    Enlist in the Paperless Revolution: Gain the Digital Advantage

    Revolutions often take just the smallest act to become a widespread movement for change. J. Sterling Morton kicked off a worldwide forestation revolution in 1872, aka, Arbor Day. And digital transformation is currently revolutionizing the way life sciences and manufacturing companies do business. Declare “War on Paper” by joining the call to arms to go paperless.

    Full story
  • 2019-bl-thumb-high-level-structure-approach-for-iso-9001-2105

    Apply ISO 9001:2015’s HLS for Improved Document Control and Compliance

    ISO 9001:2015 is currently a key focus for transition for many life science and other regulated industry organizations. The high level structure (HLS) format within the standard has explicit requirements and when implemented with a robust quality management system (QMS), can help companies improve their document control processes and compliance levels.

    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
  • 2018-bl-thumb-whats-hiding-in-your-labeling-artwork

    What's Hiding in Your Labeling Artwork?

    Because there are potential but invisible risks inherent in labeling artwork documents of life science companies that can’t be detected through manual proofreading, it’s important to be thorough and to know the tricks to detect and prevent these snags from causing unnecessary delays in the manufacturing process.

    Full story
  • 2018-bl-thumb-manufacturing-software-trends-july-2018

    The #1 Gap in Manufacturing Software Today

    It’s 2018 and technology has pervaded every area of our lives. Yet a visit to almost any manufacturing floor reveals that paper is alive and well, even in forward-thinking companies with strong IT strategies and digital transformation initiatives in place. Why is it that the truly paperless factory floor remains so elusive?

    Full story
  • 2018-bl-thumb-top-5-med-device-industry-trends-atypical tech-2

    Top 5 Medical Device Industry Trends in 2018: Atypical Medical Device Technology Will Become More Typical

    Technology companies outside of the health care sector continue to carve out a niche in the medical device industry. This trend makes the competition more flammable. Still, in many ways, disruptive technology developers may need to call upon their incumbent counterparts for assistance with navigating the regulatory pathway to compliance. This article discusses some of the regulatory stumbling blocks that could impact non-traditional medical device developers.

    Full story
  • 2017-bl-thumb-what-is-doc-control-system

    What Biotech Startups Need to Do to Slay the Competition

    Venture capitalists have pumped $2.8 billion into biotechnology startups in the first two months of this year alone. This means two things if you’re a startup. First, expect fierce competition because a huge capital pool attracts the very best in the industry. Second, this kind of investor confidence requires that you hit the ground running.

    Full story
  • 2017-bl-thumb-med-device-firms-3-tips

    Medtech Startups: How to Survive Cutthroat Competition

    In the fierce arena of medtech startups, competition is intense and investor confidence is high. A recent Ernst & Young report shows that early-stage medtech firms captured 52 percent of seed funding last year and surpassed the total amount for later-stage companies, the first time it has happened in 10 years. If you’re a startup, is it time to sit back and relax? Hardly.

    Full story
  • 2018-bl-thumb-building-vendor-qualification

    Building a Vendor Qualification Program for FDA-Regulated Industries

    A vendor qualification program is a practical and compliant methodology you can implement to vet and manage vendors and make well-informed purchasing decisions.

    Full story
  • 2018-bl-thumb-link-between-regulation-quality-systems-data-integrity

    The Link Between Regulation, Quality Systems and Data Integrity, Part 2

    An examination of how the evolving standards of data integrity are affecting regulations and quality considerations within life science industries worldwide.

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