• Ignoring This Overlooked Risk Management Metric Leads You Down The Path To The Dark Side

    13 October, 2016 by Ed Rusch, Vice President, Corporate Marketing, Elemica

    Hurricanes. Power outages. Socio - geopolitical upheavals. Train derailment. Road closures. Contamination in a supplier facility. Terrorism, cyber-attack, sabotage or industrial espionage. Labor unrest. Global pandemic. Fires, floods and natural disasters. These incidents are not a work of science fiction and the number of them that can negatively affect the supply chain are real and virtually limitless.

    Full story
  • How Well Do You Know Your FDA History?

    6 October, 2016 Lisa Weeks

    Fall is officially upon us, and we are settling into a new school year. As a child, I loved the beginning of school. It signified a fresh start

    Full story
  • Key Regulations & Initiatives that Modernized Compliance for Life Science Companies

    4 October, 2016 by Cindy Fazzi, Editor, MasterControl Insider

    Not too long ago, regulatory compliance meant color-coded stamps for various documents, gigantic cabinets for storing files, and truckloads of paper documents for FDA submissions. The advent of 21 CFR Part 11 signaled the movement toward automation. It’s one of 16 regulations and initiatives that helped modernize the compliance process for life science companies.

    Full story
  • How to Use Postmarket Surveillance Data to Gain a Competitive Edge

    29 September, 2016 Lisa Weeks, Marketing Communications, MasterControl

    Medical device companies are required to conduct postmarket surveillance (PMS) on their devices to maintain high product quality and safety. However, few companies realize the true value of the digital feedback they receive. In this post, we will explore current best practices for collecting and interpreting postmarketing intelligence, and discuss how you can use the information you acquire to gain a competitive advantage.

    Full story
  • Tweet This — If You Want to be Slapped with an FDA Warning Letter

    27 September, 2016 Lisa Weeks, Marketing Communications, MasterControl

    Is the FDA starting to get serious about how medical devices and prescription drugs are being marketed on social media? Many experts think so, citing Kim Kardashian’s highly publicized misleading endorsement of the morning-sickness medication Diclegis® as an example. The offending post, which appeared on the reality star’s personal Instagram page, earned drug maker Duchésnay a warning letter, demanding an immediate retraction. The post was promptly removed—after it had garnered 450,000 likes from Kardashian’s over 42 million followers.

    Full story
  • Preparing for the Impending Medical Device Regulation

    23 September, 2016 Linda Chatwin Esq, RACUL LLC, Senior Customer Solutions Consultant

    It’s coming – and at this point, nothing will stop it. The Medical Device Directive (MDD) is being recast to a regulation – the Medical Device Regulation (MDR). It has been over four years in the making and the EU countries have spent many hours (actually over four years) working to agree on its Consolidated Negotiated Text.

    Full story
  • Identifying and Preventing Common Data Integrity Issues

    20 September, 2016 Joanna Gallant, Owner/President, JGTA LLC

    Because of the multitude of problems being found in regulatory agency inspections, data integrity is a hot issue for regulators around the world today. Data integrity is critically important to regulators for a variety of reasons, including patient safety, process and product quality. The integrity and trustworthiness of the data provides a baseline for the regulators opinion of the personnel and the company as a whole.

    Full story
  • Is Compliance an Obstacle to Quality?

    15 September, 2016 Daniel Matlis, Founder and President, Axendi

    Can you distribute poor quality products while complying with regulatory requirements? Sure, after all, you can conduct a recall of poor quality products in compliance with all applicable regulations.

    Full story
  • "Hacking" Quality

    13 September, 2016 Peter Holtmann, President & CEO, Exemplar Global Inc.

    Continuing my theme of the future of quality, the ability to see the future could come through some interesting lenses—hacking, for instance.

    Full story
  • Free E-Book Depicts a Decade of Change in Life Science Regulatory Compliance

    6 September, 2016 Cindy Fazzi, Staff Writer

    Which came first, the chicken or the egg? This dilemma applies to automation and regulatory compliance. Did the FDA issue 21 CFR Part 11 to encourage technology use? Or did life science companies use technology first—prompting the FDA to develop corresponding regulations?

    Full story
  • Labor Day by the Numbers: Life Sciences & STEM Edition

    1 September, 2016 David Butcher, Staff Writer

    Did you know that science, technology, engineering and mathematics (STEM) job opportunities in the United States are expected to grow 17 percent by 2018? Or that 39 percent of hiring managers believe science and clinical workers are in short supply?

    Full story
  • UDI: When the Rule is Not Enough

    30 August, 2016 MasterControl

    With less than two months to go before the UDI compliance date for Class II devices, on July 26, 2016, FDA issued a draft guidance related to what would seem to be the most basic of concepts: the form and content of the UDI. More specifically, the draft guidance states that its intent is to “clarify” for industry and FDA-accredited issuing agencies the form and content of the UDI, and to “better ensure the UDIs developed under systems for the issuance of UDIs are in compliance with” the UDI rule.

    Full story
  • 10 Things I Wish I’d Known Before Writing my FDA Response Letter

    25 August, 2016 Lisa Weeks

    If you’ve ever received a 483 or warning letter, as I have, you know the chaos that can ensue. The clock is ticking; the FDA requires a response to most compliance notices within 15 business days!

    Full story
  • If Taylor Swift Were Your FDA Auditor or How to Present Yourself and Your Company During an FDA Audit

    23 August, 2016 by Marci Crane, Localization Manager, MasterControl, Inc.

    The current data show that an adult is likely to change employment at least a few times during his or her lifetime. Taylor Swift, on the contrary, is one of the rare individuals who most likely will never have to remake her career. However, surprises do happen, and would it be so far-fetched to imagine that at some point in the near future Taylor might take up auditing? And not just any auditing, but auditing for the FDA?

    Full story
  • Mayday! Mayday! These "Unknown Unknowns" Can Torpedo Your QMS

    19 August, 2016 by Walt Murray; CLA, CSSMBB ARC Experts

    In psychology, people talk about knowledge and learning in terms of four levels: what we know, what we think we know, what we know we don’t know, and what we don’t know we don’t know. In the life sciences, the fourth level, what we don’t know we don’t know (or unknown unknowns, for short), carries the most risk in quality and compliance. If you are in a leadership position, the risks are even higher. After all, how can you provide the appropriate resources or strategic direction while operating in a knowledge void?

    Full story
  • Why Russia Is an Attractive Market for Clinical Trials

    16 August, 2016 MasterControl

    When you think of countries as candidates for clinical trials, which ones come to mind? North America, Great Britain, France?

    Full story
  • QA is Like Pro Soccer and 4 Other Things You Might Not Know About QA

    11 August, 2016 Beth Pedersen

    1979 was a pretty momentous year. The Sony Walkman made its debut, Michael Jackson released his breakthrough solo album, “Off the Wall,” and Margaret Thatcher became the first woman in history to be elected as the British prime minister (more on Thatcher in a minute). But anyone who works in quality will remember 1979 for another reason altogether: the introduction of the term “quality assurance” (QA) in FDA’s 21 CFR Part 58 (1), also recognized as the first Good Laboratory Practice (GLP) regulation.

    Full story
  • Leverage the Power of SOPs

    4 August, 2016 Cindy Fazzi, Staff Writer

    Most companies establish standard operating procedures for compliance purposes, but that’s just the start and it doesn’t leverage the power of SOPs, according to Lillian Erickson, MasterControl’s global quality manager, in a recently published article in Fleet Maintenance magazine.

    Full story
  • The Most Treacherous Evil Villains and the Software They Won’t Let You Buy!

    2 August, 2016 MasterControl

    Villains, like their heroic counterparts, have interesting and complex pasts. Their complexity can be strange at times and is often hard to comprehend. After all, they generally want to kill pretty much every living creature and that can be somewhat uncomfortable for “normal” humans to process. However, taking a look at a villain’s back story and his recurring behavior can help average human beings understand why villains are constantly trying to destroy love, joy, beauty and oh yes, that professional software you’re about to purchase.

    Full story
  • 3 Areas of Focus When Responding to FDA Inspection Findings

    28 July, 2016 David Butcher, Staff Writer

    When an FDA investigator issues a Form 483 after inspecting your facility, the cited observations should be addressed in writing to the FDA within 15 days, even if the initial response will be preliminary. To prepare an appropriate response to the audit findings and get on the necessary path to mitigate and resolve the identified issues, you’ll want to focus on at least three key areas, according to ARC Experts President and CEO Walt Murray.

    Full story