Feb 23, 2017

The Migraine Known as the Supplier Audit — and Some Simple Remedies

Supplier audits don't have to be a headache 
if you know how to handle them.

by Ken Christie, COO

VTS Consultants, Inc.

The topic of supplier audits can cause severe anxiety and headaches for many biopharma companies. This pain stems from the combination of having to understand the applicable regulations, determine the elements of a supplier audit in terms of criticality, establish the frequency and type of audits to be performed based on this evaluation, and follow-up on any issues found. Sufficient time is needed to prepare for and execute such activities, and time is one thing few of us have enough of. However, without adequately planning what needs to be done, how and when to do it, and how issues will be tracked and resolved when found, a supplier audit can easily become a failed exercise.

In this article, I will review the current regulatory expectations for the qualification of suppliers through the use of on-site audits and so-called “paper audits” — for those partners deemed as critical based on the potential impact to the final quality of your product. In addition, I will provide best practices for conducting the various stages of a supplier audit, based on lessons I’ve learned while performing such audits in the biopharma industry over the years.

Feb 21, 2017

5 Reasons Why Leslie Knope Should Manage Your SOPs

Cool people make the rules,
they don’t break the rules.

by 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.

Those of you devoted fans of “Parks and Recreation” recognize Knope as the self-described, yellow-haired, waffle-loving deputy director of the Pawnee, Indiana Parks and Recreation department. Knope, played by the unflinching Amy Poehler, was an enthusiastic, naïve, by-the-book workaholic public servant with nothing but the best of intentions for her beloved town.

Feb 16, 2017

Quality Pros & the Oscars: Films to See Based on Your Personality

by Cindy Fazzi

Editor, MasterControl Insider

It’s Oscar season! From Seattle to Shanghai, movie fans are talking about their favorites, and maybe betting in their Academy Award office pool or its equivalent overseas. Watching Hollywood films is the world’s favorite pastime, judging by the U.S. film industry’s box-office revenues, which exceeded $11 billion in 2016 (1).

In the universal language of film, quality management is not all that esoteric. There’s a perfect Oscar-caliber movie for everyone regardless of age and background. Take a look at the personality types below. Which type are you?

Check out the Oscar-winning films that match your personality. If you’ve already seen them, watch them again! What better excuse to indulge in buttery popcorn and cheese-smothered nachos at home than watching a movie?

Feb 13, 2017

Recognizing the True Heroes of Life Science on Donor Day

An organ donation is the greatest gift one can give --
a single donor can save as many as eight lives

by James Jardine

Marketing Communications


The United Network for Organ Sharing (UNOS) estimates that an average of 22 people die every day because the organs they need to survive are not donated in time to save their lives. Five years ago, I was within days of becoming one of those death statistics. But the heroic actions of someone I will never know ensured that my two sons still have a father. While some may only turn their thoughts to organ donors every February 14th on National Donor Day, my gratitude manifests itself daily.

Feb 9, 2017

ISO, Regulatory Requirement Changes Loom

Several ISO quality management standards  
are changing.  Be aware of your deadlines!

by B. Christine Park



As we near the end of the first quarter of the new year, it’s time for everyone to get really serious with transition plans to the new ISO quality management systems standards and other regulatory requirement changes.  Here are a few of the recent changes:

  • ISO 9001:2015 Quality management systems – Requirements was released in September 2015 and has been in place for over a year now.  Some companies have completed the transition while others are still sorting out the requirements.
  • ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes was released in March 2016.   
  • ISO 14001:2015 – Environmental management systems - Requirements with guidance for use 

Feb 7, 2017

How to Lead with Respect

Orzen says that companies aren't 
experiencing employee engagement 
because they neglect the
"Respect for People" pillar.

by Doug Bartholomew

“Over time I’ve come to realize that engaging in this problem-solving process is actually the highest form of respect….The manager truly respects the employee’s knowledge and his or her dedication to finding the best answer….Only by showing mutual respect-- each for the other and for each other’s role-- is it possible to solve problems, make work more satisfying, and move organizational performance to an ever-higher level.”
                                           --Jim Womack, Gemba Walks, Expanded 2nd Edition, p. 5

At every organization that has embarked on a lean transformation, managers are well aware of the need to “show respect” for their people. In fact, respect for people is one of the pillars of the Toyota Way. Thus, when asked, lean managers will tell you that “employees should be treated fairly, given clear goals, trusted to achieve them in the best way, and held accountable for results,” writes Jim Womack, lean management expert and founding CEO, Lean Enterprise Institute (LEI).

Feb 3, 2017

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

Complying with EMA's transparency policy
means much of the published clinical
documentation must be redacted to 
remove personal private data.

by David Cornwell


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.

Feb 2, 2017

Your Top 10 Questions About ISO 13485:2016—Answered!

This Q&A will help you develop and implement 
a successful 13485:2016 transition plan.

by Lisa Weeks 

Marketing Communications Specialist


In early 2016, the International Standards Organization (ISO) published the long-awaited revised version of ISO 13485:2016, the standard which provides device makers with a framework for establishing a quality management system (QMS). Because it is the first major revision to the standard in 13 years, questions abound. In this post, we will tackle the most common questions asked by attendees during the many ISO 13485:2016-centric webinars we offered last year. We will also tap into the expertise of Quality Architech Christine Park, founder and president of Christine Park & Associates, and a frequent contributor to GxP Lifeline. 

Jan 31, 2017

12 Free Resources to Supercharge Your Supplier Management System

Outsourcing to suppliers is compulsory 
in today’s dynamic business environment. 

by James Jardine

Marketing Communications 


“You can have everything in life you want, if you will just help other people get what they want." 
- Zig Ziglar

To get what they truly want, businesses—just like people—often must rely on outside help. Even the most adept companies with the best ideas need to rely on external collaborators at some point if they want to achieve their aspirations and accomplish big tasks. Partnering and outsourcing are compulsory, mutually beneficial practices in today’s dynamic business environment.

Unless they are managed well, however, too many cooks in a business’ kitchen can ruin the end product. In too many instances, the continual requirements of evaluating and monitoring vendors, partners, and suppliers to ensure they maintain an acceptable level of quality can quickly snowball into a mountain of insurmountable tasks. Those requirements become even more intimidating and intense when a company does business in regulatory environments.

Jan 26, 2017

Supplier Qualification: An Important - and Often Neglected - Validation Component

Supplier GMPs are often hardly considered 
during the procurement process for 
a new computer system

Robin Nozick

Business Development Consultant

BC Solutions, LLC

I’ve been in the blood establishment software business for more than 30 years and have worked with many blood bank organizations in the United States and other countries around the world. I’ve learned that an important part of validation that is given scant contemplation and consideration is the role of supplier qualification during the procurement process. 

Often, when facilities are ready to purchase a new computer system, much time is spent assessing the functionality and usability of the possible systems. An RFP is assembled with questions meant to establish whether or not the systems under consideration will meet the needs of the organization.  This is, of course, very important since it is well established in the software business that ‘ease of use’ is necessary to keep users from making mistakes during data entry and interpretation of results.  However, the GMP (Good Manufacturing Practices) policies of the manufacturing company for the development, implementation and maintenance of the software are hardly considered at all.  Questions about the vendor’s organizational structure, responsibilities, procedures, processes, and resources for implementing quality management are given little importance.

Jan 24, 2017

Why Phil Connors Needed a CAPA Solution

What would you do if your 
CAPA was stuck in one place?

by David Jensen

Marketing Communications Specialist, MasterControl

The movie “Groundhog Day” is a timeless romantic comedy where TV weather reporter, Phil Connors, gets stuck in a time loop and relives the same day (February 2) over and over. From the opening scene it was obvious (and predictable) that Phil needed an attitude makeover, or perhaps a personal corrective and preventive action (CAPA).

I apologize in advance to those of you who haven’t seen the film, there may be some spoilers.

Jan 19, 2017

Surviving Live Data Inspections by the FDA: 3 Critical Success Factors

FDA is now requesting a "live" 
data review during inspections. For best
results, practice walking through this review
with employees who will be involved.

by B. Christine Park



I have long been a supporter of being well prepared for FDA inspections, including how data is presented during the inspection.  Historically, you’d print the files for FDA review rather than do a live demonstration of the database information.  While I haven’t experienced it yet, it is my understanding that the FDA is now requesting a “live” data review.  Essentially the expectation is for you to walk the inspector through your files and explain the information rather than have you print and organize paper files before they see it.  This innovative approach creates some new challenges and/or opportunities for your organization.  Now three main areas require your focus for success with FDA’s new electronic strategy:

1) Understand the key processes and your automation tool is configured.
2) Organize your validation documents to demonstrate the intended use of the automated tool.
3) Organize the file to create a storyboard or road map to facilitate explanation of the key documents.

Let’s take a closer look at these key areas.