August 17, 2021
By David Jensen, Staff Writer, MasterControl
The U.S. Food and Drug Administration’s (FDA) 21 CFR Part 11 guidance made electronic records and signatures as valid as paper records and handwritten signatures. The guidance changed the dynamic of data and records management by advocating modernized technology in the life sciences industry.
July 1, 2021
By Beth Pedersen, Staff Writer, MasterControl
If you’re a quality manager, you have a demanding job. In a nutshell, you’re responsible for ensuring satisfactory and consistent quality throughout every successive step of the development of your products and services, a duty which requires you to wield a massive skill set and wear many different hats. Your daily existence revolves around quality; you dissect it and measure it and evaluate it and analyze it; you sleep, eat and breathe quality. And yet, how often do you really contemplate the concept of quality, and what it means to your company beyond the daily rigors of meeting customer requirements and upholding mandatory regulations and standards?
February 9, 2018
By Jake Walton, Corporate Operations Quality Manager, MasterControl
This blog post is part of an ongoing series to provide the latest tips from experts in the field to help readers keep up with changes in the quality and regulatory industry .
January 23, 2018
By Jake Walton, Corporate Operations Quality Manager, MasterControl
External consulting firms can be used to provide expert help for many of the standard responsibilities that the quality department is tasked with. These external organizations are ready to provide you with the necessary documents to get on your approved supplier list, and can jump into work at various stages. Look for organizations that have specialized experience in the area(s) you are looking for and they can quickly and effectively help.
October 17, 2017
By Peter Knauer, Managing Partner and Co-Founder, Sage BioPartners
Corrective action and preventive action (CAPA) policies and procedures have now been a mainstay for years in most life science companies’ quality management systems due to regulation adherence to standards. With impressive technological advances, it is natural that companies are starting to develop products that span multiple sectors, and even multiple regulatory pathways. The question is, what standard/regulation do you use for your CAPA system and how do you cover all the others?
September 1, 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.
When an FDA inspector comes to your door, it is usually a time of stress and uncertainty. You need to handle logistical elements like where the inspectors are going to be placed, how you.
July 11, 2017
By Keith Matthews, Director Quality Systems, Regulatory Compliance Associates Inc.
Developing a quality system is the foundation for ensuring the organization’s products or services are safe, effective and controlled to deliver customer satisfaction. Throughout the organization’s lifecycle, from start-up through maturity, the quality needs of the firm, along with its budget constraints, are continually evolving. Maintaining compliance with regulations while controlling costs represents a challenging balancing act we encounter in our life science consultancy.
June 8, 2017
By Vivian Bringslimark, President and Owner, HPIS Consulting, Inc.
While training may appear to be straightforward to most leaders, the effectiveness follow up is anything but clear-cut. So why do business leaders frown when the answer to the training effectiveness question is – it depends?
Patients of Alzheimer’s disease, their families, and health care advocates recently encountered back-to-back disappointments when two clinical trials for Alzheimer’s drugs failed in quick succession. First, Eli Lilly & Co. stopped its late-stage clinical trial for solanezumab, then Merck & Co. ended its clinical trial for verubecestat. Both studies failed to show efficacy.
May 23, 2017
By 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.
April 4, 2017
By Paul Sanderson, Solutions Consultants Manager, MasterControl
“Quality management” is one of those terms that sounds so simple and esoteric at the same time, like DNA or free cash flow. I’m pretty sure I know what those terms mean until I start explaining them to someone.
November 29, 2016
By Patricia Santos-Serrao, Director of Product Strategy, MasterControl
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!”
November 2, 2016
By Vivian Bringslimark, President and Owner, HPIS Consulting, Inc.
Ask an operations manager and he’ll acknowledge that what it’s called is less important than getting the “assignment” done and entered into the LMS. He’s usually more concerned about the loss of productivity during the training than the effectiveness of the training at that time. It isn’t until later when the training may have to be delivered again (repeated), that the comment “training doesn’t really work” is heard.
“The Big Lebowski” never fails to make me laugh. The 1998 cult classic, starring the indefatigable Jeff Bridges, features some of the most quotable lines in film. Saying them is enough to break the ice among strangers at a party. In my family, the quotes are inside jokes that never grow old.
May 5, 2016
By Dave Hunter, Product Management Director, MasterControl
A recent warning letter to a medical device firm shows the importance of proper documentation of cleanroom maintenance procedures and corresponding control of those documents. The FDA noted the company’s failure to establish and maintain written procedures for avoiding contamination of equipment, as well as the incongruity between some of its cleanroom procedures and records of actual practice (1).
March 1, 2016
By Beth Pedersen, Staff Writer, MasterControl
Just like every other aspect of a product, quality is determined by the decisions you make in the design stages. While spending less time on planning upfront might seem to save you money, the costs associated with poor quality resulting from early design decisions can ultimately equate to 40 percent of your company’s total revenue. Correctly understanding the true nature of quality and addressing it in the design stages rather than trying to bring it in as an afterthought is the central premise of Quality by Design (QbD), and adhering to this principle could be the most cost-saving measure your company will ever take.
January 26, 2016
By Martin Browning, President and Co-Founder, EduQuest
Although FDA is strapped with limited resources and competing priorities, the Agency continues to hammer regulated companies with FDA 483 inspection observations and Warning Letters.
July 28, 2015
By 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.
