• Optimizing Outsourcing Options for Small Sponsors

    10 November, 2016 Laurie Meehan, Social Media Manager Polaris Compliance Consultants, Inc.

    What can small sponsors do to secure the outsourcing resources they need as large CROs form strategic alliances with Big Pharma?

    Full story
  • Process Validation: Life Cycle Approach Beats Crossing Your Fingers

    15 November, 2016 David Jensen

    f you do something right three times, you should be able to do it that way always. If this is your approach to process validation, Hal Baseman, chief operations officer at ValSource LLC, begs to differ. Baseman shared some insights about improving process validation at the PDA/FDA Joint Regulatory Conference in Washington D.C., Sept. 12-14.

    Full story
  • 5 Lessons Quality Pros Can Learn from Brad Pitt and Angelina Jolie’s Split

    17 November, 2016 Lisa Weeks

    As the saying goes, breaking up is hard to do. And while switching EQMS providers isn’t quite as heart-wrenching as switching life partners, it can be tough to let go. After all, you have a lot invested in the relationship, and the thought of starting over with someone or something new can be scary. However, sticking with an unsatisfying software solution that doesn’t add value out of convenience is even scarier. You owe it to yourself to move on. If you are thinking of ditching your current EQMS for another—or want to upgrade from a paper-based QMS to an electronic one—take these lessons to heart:

    Full story
  • Process Validation Habits You Should Quit Cold Turkey

    22 November, 2016 Lisa Weeks

    It’s that time again. Time to loosen our belts and get ready to eat ourselves into a food coma feasting on hot, delicious gravy-laden turkey. With turkey on the brain, I started wondering about the phrase “going cold turkey” and how it came to mean the act of quitting something (e.g., substance, behavior or habit) suddenly. And more importantly, when we should do it.

    Full story
  • GCP Compliance: Eliminating Silos between Clinical Quality and Clinical Operations

    29 November, 2016 Patricia Santos-Serrao

    In a classic episode of Seinfeld, George Costanza is terrified of the potential ramifications of his “worlds colliding” when his fiancée, Susan, becomes friendlier with his dubious pals Elaine, Kramer and Jerry. “Everybody knows you’ve got to keep your worlds apart,” George rants (but when does George not rant?) “If Susan is allowed to infiltrate this world then George Costanza as you know him ceases to exist. If Relationship George walks through this door, he will kill Independent George! A George divided against itself cannot stand!”

    Full story
  • Better IT Tools Mean Better Results

    1 December, 2016 David Cornwell

    An essential and growing component of the workforce, knowledge workers are those individuals whose primary role is the creation or management of information. Document collaboration is an increasingly common component of these workers’ daily tasks. In fact, research conducted for PleaseTech by Osterman Research reveals that during a typical month, knowledge workers create an average of 36 documents on which they will need to collaborate with others, while also being asked to collaborate on a further 34 documents. That total of 70 documents a month equates to an average of more than three documents a day.

    Full story
  • CLIA-phites vs. Quality-noids: Who Will Win the LDT Debate?

    6 December, 2016 Lisa Weeks

    The FDA’s proposed guidance for laboratory developed tests (LDTs) continues to create conflict between Quality-noids, those in favor of greater FDA oversight, and CLIA-phites, those who are not. Historically, the FDA has exerted little oversight of LDTs (e.g., no premarket review or quality system requirements) but that’s changing, largely because today’s LDTs are far more complex than the LDTs of the past. Both sides agree that more oversight is needed. Which federal agency should provide it, however, has sparked intense controversy.

    Full story
  • Top 8 Ways to Reach Regulatory Compliance

    8 December, 2016 MasterControl

    Many companies doing business in regulatory environments treat compliance like another obstacle to success. However, companies that live in regulatory environments have come to understand that compliance is actually a tool that can give them a competitive advantage. Statistics show that 72 percent of senior executives at regulated companies say that ensuring compliance with regulatory requirements is one of the most important challenges in their company.

    Full story
  • Rogue Documents: A Standard Story

    13 December, 2016 David Butcher, Staff Writer

    When Rogue One: A Star Wars Story arrives in theaters this week, audiences will finally learn how the Rebel Alliance got their hands on the Death Star plans, an event referenced in the opening crawl of the original 1977 film. For the Empire, failing to secure its critical information – the Death Star plans – was catastrophic. For an organization working in a regulated environment, failing to maintain control over all of its critical documents and data can also be devastating.

    Full story
  • Lean Thinking: A Roundup

    15 December, 2016 Tom Ehrenfeld

    This month marks the 20th anniversary of the publication of Lean Thinking, the book that helped popularize what many of us today know as “lean.” Over the next two days on the Lean Post, authors Jim Womack and Dan Jones will discuss how their thinking has evolved since its publication. Keeping in spirit with past roundups of other lean topics, here’s a recap of the book, as well as a look at several resources giving context to this thing called lean.

    Full story
  • Santa Claus Is REAL but He Requires an EQMS!

    20 December, 2016 Marci Crane

    Once upon a time your parent or some “responsible” adult decided to be a big dope and tell you that Santa Claus wasn’t real. You, always the awesome kid on the block, took the news with grace but nevertheless it carved a scar onto your tender little heart.

    Full story
  • Love it or Hate it, the 21st Century Cures Act is a Big Step Forward

    21 December, 2016 Cindy Fazzi, Staff Writer

    The 21st Century Cures Act is a massive piece of legislation (996 pages) with an equally tremendous ambition. The life science industry heralded it as a victory, while critics expressed some concerns. Everyone agrees, however, that there’s a need to support medical innovation and advance regulatory compliance. The reform-minded law unites all sides to that extent.

    Full story
  • 5 Ways Artificial Intelligence Is Changing Health Care and What It Means for Quality Management

    27 December, 2016 Beth Pedersen, Marketing Communications, MasterControl

    Health care data is expected to reach a staggering 2,300 exabytes (one exabyte is equal to one billion gigabytes) in 2020. We all know knowledge is power, but the amount and complexity of data in existence has long since outpaced the human mind’s ability to access and process it. Enter artificial intelligence (AI). Since its inception over half a century ago, AI has experienced an ebb and flow of attention, investment, development and scrutiny but one idea persists: the promise of making human lives significantly better.

    Full story
  • Protect Your Investments!

    29 December, 2016 Dr. Christopher Joseph Devine, President, Devine Guidance International

    Did you miss old doctor? Dr. D is back from a two-week hiatus that included some drinkin’ and thinkin’, and is again ready to continue with the dispensing of guidance for solving the day-to-day challenges associated with the medtech industry. Helping Chief Jailable Officers (CJOs) navigate the often treacherous regulatory waters associated with compliance to quality, regulatory and statutory requirements has always been one Dr. D’s salient goals, along with providing a few chuckles. Besides, the

    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
  • "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
  • How to Minimize Protocol Deviations

    1 May, 2018 Laurie Meehan, Social Media Manager, Polaris Compliance Consultants

    Get off the list of the U.S. Food and Drug Administration's (FDA) most common site inspection finding — protocol deviations. Make sure your staff read and understand protocols, how they work and what types of deviations inspectors are looking for.

    Full story
  • 5 CAPA Best Practices You Should Be Doing Now

    5 January, 2017 Cindy Fazzi, Staff Writer

    Let’s play a quick word association game. If I say CAPA, I’m betting someone will say manufacturing. The concept of corrective action and preventative action is indeed associated with product quality in manufacturing because of long-standing regulations and standards requiring CAPA in that sector. However, MasterControl’s Patricia Santos-Serrao says you can and should leverage CAPA principles in clinical research.

    Full story
  • 5 Things I Learned about FDA Audits from its Sister in Compliance, the FCC

    10 January, 2017 Anthony Rossi, Sales Operations Specialist, MasterControl

    Before I came to work at MasterControl, I was an operations coordinator at a company called CaptionCall. CaptionCall provided telephone captioning to the hard of hearing, and because it was funded through federal taxes we were directly overseen by the FCC. While I was working at CaptionCall, I was directly involved in an audit performed by the FCC. The day of the inspection was one of the most stressful days in my career.

    Full story
  • 5 Tips for Bolstering Cybersecurity

    12 January, 2017 David Jensen, Marketing Communications, MasterControl

    Cybersecurity can be exhausting and difficult to control—even for IT pros. A security risk management executive at AbbVie Inc., discussed cybersecurity at the 2016 PDA/FDA Joint Regulatory Conference and offered some tips for how you can ramp up your organization’s IT security efforts.

    Full story