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Showing items tagged as SOP

  • What is a Document Control System?

    12 May, 2017 David Jensen

    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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  • Three Keys to Successful FDA Inspections – Preparation, Management and Follow Up

    28 July, 2015 Kelly Thomas, Atlantic Validation

    Successfully completing a FDA inspection is critical to cGMP operations and commercial success. Implementing and maintaining robust quality systems is one element to accomplishing this goal. However, it is not the only element. Inspection preparation and management is another, equally important element to ensure a successful outcome. In fact, proper Inspection management techniques can help mitigate the risk of receiving an observation for compliance gaps. This article will provide insight on understanding the inspector, discuss how to prepare for and manage the actual Inspection, describe follow-up activities required for close-out, as well as describe real-life lessons learned.

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  • 4 Reasons Why Document Review is Crucial to Compliance

    25 June, 2015 Cindy Fazzi Editor, MasterControl Insider

    When was the last time you reviewed your quality documents? If you don’t review them, how do you know if you need to update and revise them? These are the questions that Marty Jackson1, a MasterControl professional services consultant, asks new clients who are switching from a paper-based document management process to an automated system. In most cases, they are stumped.

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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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  • Five Steps to Building Process Efficiency with Your Supplier

    20 January, 2015 Stephen Gerald O’Neil, Consultant

    In order to achieve success with your outsourced manufactured medical devices, there must be cohesiveness between the manufacturer (Supplier) and the product developer (Customer). I’ve exemplified this role as that of the supply chain liaison consultant, involved directly with the development of the manufacturing processes, while in step with the roll-out of the product design intent. This article will discuss the five steps required to accomplish all of this while defining the role of the consultant. The consultant provides the tools and leadership to maximize the value of the supplier in their partnership with the customer.

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  • FDA vs. EU Inspections: Similarities & Differences

    14 October, 2014 Marie E. Dorat, CQA, CAA IPRF, LLC – RA/QA Consulting & International Product Registration EU-FDA Joint Initiative

    The U S Food and Drug Administration (FDA) and European Medicines Agency (EMA) Good Clinical Practice (GCP) initiative started a joint inspection program in September 2009.  This inspection program targets investigator sites, sponsors, and contract research organizations (CROs) in either the US or the European Union (EU).

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  • How Do I Follow The Trail?

    1 May, 2014 by Jamie Colgin, President, Colgin Consulting, Inc.

    One of the most effective audits I ever participated in started with a systems-naive auditor asking a simple question: "Imagine I'm a sample arriving at your loading dock. What happens to me?" We proceeded down the trail together, following the sample through the processes of accessioning, analysis, reporting, and storage.

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  • 10 Guidelines for Writing Superior SOPs

    18 December, 2013 Robyn Barnes, Public Relations Specialist, MasterControl Inc.

    Will you be prepared when tasked to write a standard operating procedure (SOP)? Writing SOPs--- shorthand for a written document that helps ensure accuracy and repeatability when executing a task---is an integral part of assembling a successful quality system. When poorly written, they are of limited value.  Using the following 10 guidelines, you can create a successful SOP document.

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  • What If You Needed SOPs to Run Your Household?

    5 December, 2013 Laurie Meehan, Internal Project Manager, Polaris Compliance Consultants, Inc.

    In August, I traveled to Phoenix to videotape a presentation for Natural Products INSIDER’s Digital Summit.  The presentation, entitled “A Guide to SOPs and Compliance for Dietary Supplement Distributors,” goes into much more detail than our February blog post on the same subject (which you can read here:

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  • Stay Ahead of the FDA: Process Mapping, Gap Analysis and SOP Review

    18 April, 2017 Kerry Potter, Founder and President of Summit Consulting, Inc.

    What happens when the FDA arrives at your manufacturing facility? Your first reaction may be panic or perhaps regret for not having solved any wayward problems the inspection team will surely now find. But it does not have to be that way. In fact, by preparing in advance and using the right tools, a firm should be able to greet the FDA by saying, "Excellent. Everyone knows what to do. Let's get right to it." That is the exact attitude companies need to have to successfully pass any inspection.

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  • Writing and Enforcing Your SOPs for GxP Compliance Success - for Quality Professionals

    14 July, 2011 David R. Dills, Quality & Compliance Advisor

    This paper addresses the fundamentals of writing and enforcing your SOPs not only for compliance and in accordance with internal company policies and requirements but certainly for ensuring compliance with FDA requirements as well.

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  • Writing and Enforcing Your SOPs for GxP Compliance Success - for Life Science Professionals

    31 January, 2012 David R. Dills, Quality & Compliance Advisor

    Writing and developing solid operational procedures is a skill that develops over time. Procedures are usually fairly technical and often describe complex subjects. These procedures are reviewed by subject-matter experts, as well as by internal and external auditors and by employees at all levels of the organization. Therefore, it is important to consider the language used when communicating an idea.

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