Showing items tagged as Document Control

  • Collaboration is More Than Just a Buzzword in Regulated Environments

    10 February, 2014 Marty Jackson, Professional Services Consultant, MasterControl Inc.

    Each year, there seems to be a buzzword that pervades the business community. This year, I recall hearing the word “collaboration” more than ever. For most organizations, the word is synonymous with “participate.”

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  • Beyond Writing It Down

    19 February, 2014 by David A. Gallup, Ed. D. Principal, GMPTraining.com, Inc.

    “If it isn’t written down it didn’t happen” is drummed into everyone working within the pharmaceutical industry.

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  • Making the Business Case for Implementing an Electronic QMS

    18 March, 2014 by Lisa Weeks, MasterControl Inc., Marketing Communications

    In a tough economy, quality professions often find themselves having to convince management that swapping their paper-based QMS for an electronic one is worthy of the expense and will translate into bottom-line, as well as compliance, benefits. While the regulatory and legal drivers for automating your quality processes are irrefutable, the frequently overlooked operational and business opportunities enjoyed by organizations that implement an electronic QMS are equally compelling. Simply put: compliance is good for business, and the right QMS software can help you transform your compliance challenges into tangible business advantages.

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  • Report from MD&M West Conference: Navigating through the PMA and 510(K) Submission Processes

    15 April, 2014 by Peter Knauer, Senior QCC Consultant, MasterControl Inc.

    I recently had the opportunity to chair a track and present a session on FDA and a Global Regulation in Practice at the MD&M West Conferen Trouble-Free Validation with MasterControl (1:38)ce. The conference was held at the Anaheim a Convention Center from Monday, February 10th through Thursday February 13th, 2014. Below is a summary of the proceedings for Day 2: NAVIGATING THROUGH THE PMA AND 510(K) SUBMISSION PROCESSES.

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  • How to Cut Your Document-Approval Cycle Time Using Escalation

    27 May, 2014 by Marty Jackson, Professional Services Consultant, MasterControl Inc.

    From SOPs and procedures to CAPAs and deviations, most regulated companies maintain document-based and form-based processes for compliance and business reasons. How do you get approval for your documents and forms? How many processes do you have and how long is your approval cycle time for each one?

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  • How Can You Measure the Return on Your QMS Investment?

    29 May, 2014 by James Jardine, Marketing Communications, MasterControl Inc.

    Every provider of electronic quality management systems claims its product will give you a significant return on your investment. But how can this ROI be truly measured? To find out, MasterControl recently surveyed customers to learn more about their levels of waste and efficiency before and after implementation of MasterControl's quality management system (QMS). Some of the results of the survey are compiled here in an informative infographic.

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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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  • Questions All Auditors Should Ask: The Use and Misuse of Audit Checklists

    31 July, 2014 by Laurie Meehan, Polaris Compliance Consultants, Inc.

    There’s nothing wrong with using a good checklist, as long as you remember that there will always be something wrong with your checklist. It is simply not possible to develop a checklist that will get to the core of every problem, that will cover every scenario, or that will ever be any reasonable substitute for that all important question: “Why?” So how can you develop the best checklists possible and avoid relying on them too heavily?

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  • Regulatory Records Primer Part 1: Decoding the Requirements for Medical Device Manufacturers

    21 August, 2014 Les Schnoll, Quality Docs, LLC

    The Quality System Regulation (QSR) is premised on the theory that the development, implementation, and maintenance of procedures designed to carry out the requirements of the regulation will assure the safety and effectiveness of medical devices. Therefore, it is easy to see the importance of the records required to document the implementation of those quality system procedures. One of the basic themes of the Quality System Inspection Technique (QSIT) (used during inspections of medical device manufacturers) is the “Establish Test.” The QSR requires many procedures to be “established” and defines “establish” as “define, document (in writing or electronically), and implement.”

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  • Regulatory Records Primer Part 2: Decoding the Requirements for Pharmaceutical Manufacturers

    26 August, 2014 Les Schnoll, Quality Docs, LLC

    In Part 1 of the Regulatory Records Primer (Decoding the Requirements for Medical Device Manufacturers), I discussed the general requirements and thought processes undertaken by the FDA with respect to regulatory records.  While the drug side has not yet “evolved” to using a quality systems approach to the regulatory requirements, the same basic process holds true.  Following is a discussion on the regulatory records required to be maintained by manufacturers of finished drug products.

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  • Surviving ISO 9001: 2015

    4 November, 2014 Christopher Paris, VP Operations, Oxebridge Quality Resources

    The next revision of ISO 9001 is due in 2015, and the standard is being anticipated with more controversy than any previous edition. The document, now in its Draft International Standard (DIS) stage, is nearly a done deal, with very few changes likely before it progresses to its final release.

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  • American Laboratories Begins Phase II of MasterControl

    12 November, 2014 MasterControl

    American Laboratories, Inc. (ALI), Omaha, NE, a manufacturer of Pancreatin, Pepsin and proteins is celebrating two years with the quality management system MasterControl and is announcing the implementation of Phase II of the system that will include Quality Events Management.  

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  • Two Keys to Prosperous B2B Customer Partnerships

    4 December, 2014 James Jardine, Marketing Communications

    It may be a trite and simplistic aphorism, but it’s one that’s hard to live by in a competitive business world. Yet the companies that stay true to it are always the most successful. That’s because a company that provides products and services to other businesses is only as valuable as the value it supplies. Think of it this way: ‘why’ a company does what it does is even more important than ‘how’ the company does it or ‘what’ it is actually doing.

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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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  • 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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  • 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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  • 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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  • 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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  • 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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  • 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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