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Showing items tagged as Document Control

  • FDA Experts Give Top 10 FDA GMP Inspection Citations for FY 2017, Part 1

    22 May, 2018 by Jerry Chapman, Editor-in-chief, Xavier Health, and GMP Quality Consultant

    Experts at the FDA/Xavier PharmLink conference at Xavier University in March 2018 presented and analyzed the FDA's top 10 drug GMP inspection citations for FY2017 during a panel discussion. The first part of a two-part series.

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  • 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.

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  • UK's MHRA Issues Final Guidance on GxP Data Integrity

    19 April, 2018 by Mark Schwartz, Director, Hyman, Phelps & McNamara

    Glean some insights from the U.K. 's Medicines and Healthcare Products Regulatory Agency (MHRA) recently published final guidance on GxP Data Integrity, two years after the U.S. Food and Drug Administration (FDA) issued draft guidance on data integrity and compliance with Current Good Manufacturing Practice (CGMP).

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  • Poll Suggests Automation Could Solve 85% of Your Document Control Issues

    20 March, 2018 by Mike Rigert, Staff Writer, MasterControl

    The sophistication and value-added benefits of automated, integrated document control management tools available to manufacturers in the life sciences has come a long way since software solutions were introduced in the 1980s on 5 1/4-inch floppy disks.

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  • February Tip: Managing Updates to Regulatory Documentation

    22 February, 2018 by Tamara Burch-Williams, Professional Services Implementation Manager, MasterControl

    Tip: When the change occurs, review the current regulatory submission(s) and note where updates are needed. Even better, create a working or dynamic version of an updated submission.

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  • EU Policy 70 and Redaction — PleaseReview’s Take on It

    1 September, 2017 by David Cornwell, Founder/CEO, PleaseTech Ltd.

    This blog post is primarily about how PleaseReview can assist life science companies in the process of complying with the European Medicines Agency (EMA) transparency policy 70 on the publication of clinical data. However, it also discusses how we at PleaseTech plan to expand PleaseReview’s redaction (or masking as it is sometimes known) capability over the next six months, so this post may be of interest to those readers with other redaction challenges.

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  • What Is a Quality Control System and How Can an EQMS Improve On It?

    15 August, 2017 David Butcher, Staff Writer, MasterControl

    For organizations doing business in regulatory environments, successful quality assurance and quality control are crucial aspects of quality management in FDA- and ISO-regulated environments. Often, “quality control” and “quality assurance” are used interchangeably, referring to the activities conducted to ensure the quality of a product, service or process. While some quality control and quality assurance activities are interrelated, however, the two

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  • The 15 Strangest Phobias and Why They Include the Fear of Paper

    23 May, 2017 Marci Crane, Staff Writer, MasterControl

    It’s difficult to label any phobia as the “strangest” because most phobias are considered kooky, weird or downright bizarre. Phobias are also nearly impossible to understand with the logical mind – they just don’t seem to make sense! However, for those experiencing a true phobia, logic doesn’t make one bit of difference. The terror is still alive and well.

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  • What Is a Document Control System?

    12 May, 2017 David Jensen, Staff Writer, MasterControl

    Being in the regulated manufacturer arena, you have heard that oft recited phrase “if it isn’t documented, it didn’t happen.” This motto shared among life sciences companies means an efficient document control system is at the core of quality management. Documents and records serve as proof that your company follows good manufacturing and document management practices required for compliance.

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  • What is a Document Management System and 8 Reasons Your Company Probably Needs One

    9 May, 2017 Marci Crane, Staff Writer, MasterControl

    A document management system is a software solution that allows for the digital management of documentation. Today most documentation managed by document management systems is business-related.

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  • 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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