• Life Science Polls Reveal Lack of Automation, High Cost of Quality Stoppages

    4 May, 2017 Cindy Fazzi, Staff Writer, MasterControl

    Increased automation through digital technology platforms is one of the top business trends for 2017 (1). It’s a crucial enabler for businesses to compete successfully, according to the IT research and advisory company Gartner Inc.

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  • 5 Reasons Why Leslie Knope Should Manage Your SOPs

    24 January, 2017 David Jensen, Marketing Communications

    Compliance observations and warning letters regarding standard operating procedures (SOPs)—or the lack of—in life sciences manufacturing facilities are as common as fruitcake during the holidays. How can medical device and pharmaceutical manufacturers hope to reduce the exorbitant number of documentation infractions? Get Leslie Knope to manage your SOPs.

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  • 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

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  • 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.

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  • 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.

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  • 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.

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  • 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.

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  • 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?

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  • 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.

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  • Accelerate Time-to-Market by Improving Process Validation

    24 May, 2016 James Jardine, Marketing Communications, MasterControl

    Process validation, a general term for critical disciplines such as risk mitigation/management, quality assurance and change management, is something that far too many life science manufacturers only worry about when a product is just about to go to market. That late in the game, though, it can be hard to produce the required and relevant information that has accumulated during years of product development. In a recent article in PharmTech titled “Reducing the Documentation Burden in Process Validation,” Patricia Santos-Serrao, RAC, of MasterControl explains how regulatory agencies define process validation as it pertains to the collection and evaluation of data from the process design stage all the way through to commercial production.

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  • Don’t Trip over These 9 Document Control Pitfalls

    26 April, 2016 Dave Hunter, Product Management Director, MasterControl

    Document control issues are among the most commonly cited observations in FDA Form 483s and warning letters. In the medical device sector alone, document control-related issues represented 10 percent of Form 483 observations and 8 percent of warning letters in 2014(1).

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  • 4 Downton Abbey Characters Who’d Make Great Quality Professionals (and 4 Who’d Be Bloody Awful)

    21 April, 2016 Lisa Weeks, Marketing Communications, MasterControl

    Are you experiencing Downton withdrawal now that the award-winning PBS costume drama is officially over? You’re not alone. Monday morning water cooler banter hasn’t been the same since our friends in the Great House threw the dust shields over the furniture and bid us farewell. If you’re missing your favorite Downton characters, don’t fret. There is probably a Mr. Carson or Lady Mary sitting in the cubicle next to you. After all, several members of the Crawley household, upstairs and down, possess the skills and personality traits needed for a successful career in quality management—others clearly don’t. Warning: Spoilers ahead!

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  • Med Device: How to Address the Documentation Burden of Design Control

    12 April, 2016 Matthew M. Lowe, Executive Vice President, MasterControl

    Design control issues represent a key challenge for many medical device firms. This is the reason why in 1996, the U.S. Food and Drug Administration (FDA) added design control principles to 21 CFR Part 820 and required rigorous documentation to demonstrate design control.

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  • Inspection Readiness: Leveraging Inspection Focus Areas and Increasing the Transparency of Investigator Oversight

    1 December, 2015 Jessica Masarek, Quality Assurance Consultant | Independent Auditor Director, Muse Clinical

    Audits and inspections seem to be wrapped in a shroud of mystery, making folks stressed and unsure of exactly what is going to happen. What if I say the wrong thing? What if I don’t know the answer? What if I can’t provide what they are asking for? Realistically, all of these things will probably happen! That said, as long as you are honest, all will be well. Mistakes happen and no auditor or inspector is expecting perfection. We are expecting transparency. As an auditor, my goal is to confirm that the trial is run in a way that ensures the safety of subjects, protects their rights, and generates reliable data. Sponsors want to continue working with sites in which so much effort has been invested and will work to identify areas for improvement if deficiencies are noted. An inspector has a similar goal with respect to the assessment of trial conduct. So, how do we ensure that trials are run at the level of quality that regulators are looking for and that are truly inspection ready?

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  • 7 Steps to Respond to an FDA 483 Inspection Observation

    15 July, 2014 by Robert Packard, President, Medical Device Academy

    Responding in 15 days is one of seven steps on how to respond to an FDA 483 inspection observation. This blog post also includes advice from a former FDA investigator.

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  • Tales from the Front

    9 June, 2015 Morris Sherwood Director, Regulatory Affairs and Quality Assurance Isolite Systems

    So far in my 26 years of working in medical devices I have had many an adventure when it comes to FDA and Notified Body Inspections. I love inspections. I know it sounds crazy but there is this Zen place you get to during an inspection. You must practice patience. You must not think you know exactly what your inspector is thinking. At the same time, it is this amazing game of psychological chess whereby you watch your opponent’s moves and think five moves ahead, only to have your strategy thrown out the window when the inspection zigs rather than zags.

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  • Regulatory Affairs & Regulatory Operations: The Air Traffic Control Tower of Life Sciences

    2 April, 2015 Patricia Santos-Serrao,MasterControl's Market Segment Manager, Global Pharmaceutical, Blood & Biologics

    When describing the role of Regulatory Operations I have found that one of the best analogies of their role and responsibilities is to be the “air traffic control tower for interactions between a life sciences organization and a regulatory authority.” By no means is that their only role but it is an essential role that involves constant communication with various parties both internally as well as externally. Regulatory Operations personnel coordinate resources and documentation essential for filing of global applications such as INDs, NDAs, BLAs and MAAs for pharma/biotech organizations and of 510k and PMAs for medical device organizations.

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  • Four Reasons to Automate SOP Management in FDA and ISO Environments

    26 February, 2015 David R. Butcher, Marketing Communications, MasterControl

    To maximize efficiency and safety, successful companies across all industries employ effective standard operating procedures (SOPs). For companies doing business in regulatory environments, effective SOP management is imperative. An electronic SOP management system can dramatically improve SOP management in at least four key areas.

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  • 7 Document Management Blunders that Jeopardize Compliance

    25 February, 2015 James Jardine, Marketing Communications, MasterControl

    Achieving regulatory compliance without any document management slipups is like walking through a dog park without getting your shoes messy. It seems nearly impossible to find a safe route to your compliance destination and there are countless potential mistakes you can make at any step along the way. Since the path to compliance is narrow and treacherous, here are seven examples of common document management mistakes that can jeopardize your compliance and a few ideas on handling these types of problems.

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  • Risk Management: A Primer for Lean Quality Assurance

    6 January, 2015 Gina Guido-Redden Co-Founder, Coda Corp USA

    In this article, we will take a closer look at what is becoming perhaps the most useful tool in the belt of today’s quality professionals: risk management.

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