Apr 27, 2017

"We're Different!" Overcoming the Challenges of Applying Lean Principles to Knowledge Work

Lean process improvement techniques 
can be applied to knowledge work and
knowledge workers.

by Drew Locher




Change Management Associates

If you are applying lean management principles to R and D, life science, or other knowledge work processes, you’ve probably heard the "we're different” argument. It usually goes something like this, “You can’t apply lean process improvement techniques to creative work because everything we do varies."

Knowledge work and knowledge workers are different. But that doesn't mean process improvement concepts don’t apply. It does mean we have to adapt the concepts and approaches by practicing these proven techniques.

Apr 24, 2017

20 Years Later, 21 CFR Part 11 is More Relevant than Ever

by Cindy Fazzi

Staff Writer, MasterControl

If 21 CFR Part 11 and the life science industry were a married couple, they would be celebrating their platinum wedding anniversary this year. For better or for worse, in sickness and in health, it has been 20 years of compliance. It’s an important milestone to celebrate and think about.

First off, what’s new with Part 11? Every now and then, there are rumors about updates. The on-again, off-again speculation stems from the FDA’s “Guidance for Industry: Part 11, Electronic Records; Electronic Signatures—Scope and Application.”

The 2003 guidance says: “While the re-examination of Part 11 is underway, we intend to exercise enforcement discretion with respect to certain Part 11 requirements” (1). And yet, neither re-examination nor update is apparent.

Apr 20, 2017

What Do Food Facility Auditors Really Want? A Practical Guide to Reducing Your Audit Stress Level

Does preparing for your next
audit give you a headache? PDCA
may help reduce your audit stress.

by Bryan Armentrout

CEO, The Food Leadership Group

Third party audits are critically important to food companies. They are the primary tool your customers use to determine if adequate food safety systems are in place. This article covers some of the strategies and tactics you should employ to maximize your chances of a successful audit.

Does this Scenario Sound Familiar?

A big audit is coming up. The plant has been preparing for months and this is the final team meeting before the auditor arrives. At some point during the meeting the plant manager turns to the quality assurance (QA) manager and says, “Are you ready for the audit?” The QA manager swallows hard and responds, “As ready as we are going to be.”

Apr 18, 2017

Human Factors: Why it is Critical in Designing Medical Devices

Human factors helps design out 
the opportunity for human error

by David Jensen

MasterControl Staff Writer

“Most of the time spent wrestling with technologies that don’t quite work yet is just not worth it for end users, however much fun it is for nerds.” 
---Douglas Adams.

This quote hints at the importance of human factors in technology in medical device design and development. Rollin Fairbanks, director, National Center for Human Factors in Healthcare, talked about human factors and its critical role in medical device design at the PDA/FDA Joint Regulatory Conference in Washington D.C., Sept. 12-14, 2016.

Many issues or mishaps involving medical devices can be attributed to human error. However, instead of focusing on discipline, mindfulness and training of end users, Rollin stressed that human error cannot be eliminated, but it can be significantly reduced with the right approach to product design.

Apr 13, 2017

Site Selection: Don’t Forget About the Study Drug

When conducting GCP audits,
many criteria must be checked
including those that affect the
drug you are testing.

by Laurie Meehan

Social Media Manager

Polaris Compliance Consultants, Inc. 

As a sponsor or CRO, you understand the importance of a thorough site selection process. A site needs to be able to meet enrollment targets and timeframes, protect the rights and safety of study participants, execute the protocol, deliver quality data, and maintain GCP compliance. That’s what your site feasibility surveys and pre-study visits are designed to evaluate. And as you’re assessing a site’s abilities, the site is conducting its own feasibility process. They’re mining their patient database and assessing inclusion/exclusion criteria. They’re reviewing staff credentials and ensuring they have adequate resources to manage the number of subject visits and collect the data the protocol requires.

But when we conduct GCP audits, we find there’s one perspective that is sometimes overlooked by both sides: the needs of the study drug itself. 

Apr 11, 2017

Top 5 Takeaways from MedTech Intelligence’s Medical Device Cybersecurity Conference

by David Jensen

MasterControl Staff Writer

I recently attended a conference on Medical Device Cybersecurity hosted by MedTech Intelligence held March 23-24, in Washington, DC. It’s evident that cybersecurity is an important concept as attendance, both in-person and remote, was high. Conference organizers lined up a powerhouse group of presenters who are all entrenched in the technology, cybersecurity, legal and regulatory compliance industries.

For two days, attendees had the opportunity to hear from and converse with officials from FDA, cybersecurity experts from the Mayo Clinic and the Medical Device Innovation Safety and Security (MDISS) Consortium, attorneys specializing in life sciences and healthcare and engineers in medical device manufacturing.

For those of you who were unable to attend this event, here are my top 5 takeaways:

Apr 6, 2017

4 Rules for Building an eClinical Qualification Framework

by Rob Sims

UL Compliance To Performance

Marketing Programs Manager

As clinical trials continue to expand globally, technology plays a critical role in maintaining data integrity and at the same time accelerating study start-up. Consider a study management team that must travel globally to hold investigator meetings. Travel now takes up a much greater portion of the study management team’s time and energy.  That’s why study teams have turned to eClinical technology to reduce this effort – from preclinical R&D and regulatory communication to packaging/distribution and post marketing studies. 

In this clinical ecosystem is also site personnel qualification technology, which must be targeted to each role within the clinical research site. Otherwise, individuals within the site would receive too much or not the right protocol and non-protocol items that align with their role.

Apr 4, 2017

How to Practice Quality Management in Your Personal Life

by Paul Sanderson

Solutions Consultants Manager


“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. 

I've worked in the quality software business for over 12 years, and I still don't know what to say when someone asks me what I do for a living.

It generally goes like this:

Mar 30, 2017

5 Warning Signs of Diminishing Supplier Quality

Medtech manufacturers who don't know 
what signs to look for will struggle to know
if a supplier's quality system is failing.

by David R. Butcher

MasterControl Staff Writer

Is your supplier’s quality system doing what it’s supposed to be doing? Would you know if it weren’t? How would you know if there were flaws in your supplier’s quality processes before the problems get worse? These are the questions MasterControl’s Terrance Holbrook attempts to answer for medical device manufacturers in a recently published post on MDDI’s Device Talk blog.

“If a manufacturer doesn’t know what signs to look for, it will struggle to know if a supplier’s quality system is failing, let alone keep the results of poor supplier quality from spreading,” according to Holbrook, a senior product manager with 20 years of industry experience in manufacturing and seven years in product development of medical devices.

To anticipate supplier quality issues before problems spread, manufacturers should be mindful of the following five red flags, which should alert you to declining supplier quality.

Mar 27, 2017

When You Find Yourself Between a Rock and a Hard Place

Adventurer Aron Ralston is a survivor
 if there ever was one.

by Beth Pedersen


MasterControl Staff Writer

We all have those days where everything that can go wrong, does. Where it seems the entire universe is working against you, testing your patience, your determination and your will to carry on. But in the scheme of things, are these so-called bad days really that bad?

Aron Ralston, an experienced outdoorsman and climber, took the concept of a bad day to a whole new level when he found himself alone and trapped in a remote Utah canyon, his arm pinned by a massive 800-pound boulder. Five days and seven agonizing hours later, Ralston’s extremely bad day had become nothing short of a life-or-death situation. To survive, he was faced with an unthinkable decision, and the ordeal would forever change his perspective on what truly matters in life.
The survivor and best-selling author will share his harrowing experience along with wisdom on how to conquer life’s “boulders” – both big and small – in the keynote address at the 2017 Masters Summit, MasterControl’s largest annual user conference, to be held on Oct. 10 in Salt Lake City.

Mar 23, 2017

FDA Guidance Answers Questions Regarding Data Integrity

FDA is seeing too many 

data integrity-related violations.

by David Jensen

Marketing Communications


An alarming increase in CGMP violations involving data integrity has come to the attention of FDA. To spotlight this issue, the regulatory watchdog has drafted a question-and-answer-based guidance, “Data Integrity and Compliance with cGMP.” The purpose of the guidance is to address some of the frequently asked questions and to clarify the role of data integrity in drug manufacturing.

FDA finds the increase of data integrity violations troubling. Nevertheless, the agency’s current position on the content of the guidance is that it should be viewed only as recommendations. The use of the word “should” in Agency guidances means that something is suggested, but not required.

Mar 21, 2017

The Most Important Four-Letter Words in ISO 9001:2015

If transitioning to the new ISO 9001:2015, 
be very familiar with both four-letter words
emphasized in the document: risk and plan.

by Christine Park

Christine Park & Associates

Most organizations are well under way with the transition to the new ISO 9001:2015.  As such you should be very familiar with the emphasis on two four-letter words found throughout the document …. risk and plan. While these words are emphasized throughout the document, they aren’t new within the business or quality management systems.

Risk-based thinking is something we all do every day and has always been important in business management.  Now that the new ISO standard requires the quality management system to be aligned with business strategy, the use of risk management allows for greater flexibility and less prescription.  Additionally, the use of risk is considered a preventive tool and since it has been integrated throughout the standard, the specific clause for preventive action was eliminated from the standard.

Mar 16, 2017

FDA Eager to be Innovative Partner with Expedited Access Pathway

Expedited Access Pathway: for patients
who have few or no other options.

by David Jensen

Marketing Communications


Part of FDA’s prime directive is to assure the safety, effectiveness and quality of biological products and medical devices. So the notion of FDA endorsing the acceleration of product development might raise some eyebrows. However, FDA officials and industry experts alike seem to agree that with some patients waiting is not the hardest part, it’s actually not an option.

Two accelerated manufacturing programs currently in the spotlight are the 21st Century Cures Act and its medical device sibling, the Expedited Access Pathway (EAP) program. Dissenters believe these programs might compel FDA to relax its regulatory oversight in order to fast-track a product’s development and manufacturing. According to Center for Devices and Radiological Health (CDRH) director Jeffrey Shuren, it’s quite the opposite. In an FDA Voice blog post, Shuren summed up EAP as a way to “speed qualifying devices to patients with life-threatening or irreversibly debilitating conditions without compromising FDA’s high standards for safety and effectiveness.”

Mar 14, 2017

The Inner Game of Continuous Improvement

Overcoming anxiety and self-doubt can
help you win in sport and in your career.

by Jon Miller

Co-founder and Partner

Gemba Academy

Five-time Superbowl winner Tom Brady credits reading The Inner Game of Tennis by Tim Gallwey for helping him overcome anxiety and self-doubt, and to keep winning. I read the book looking for parallels and general lessons that could be applied to workplace performance and continuous improvement, and was not disappointed. Here is a summary of what I learned about what I will call “the inner game of continuous improvement.”

Mar 9, 2017

Brave New World: The Mutual Recognition of CGMP Inspections

The United States and the European Union
 have agreed to to recognize inspection
 of each other's drug manufacturing facilities.

by Mark I. Schwartz 


Hyman, Phelps & McNamara PC

Last week, the United States and the European Union agreed to recognize each other’s drug cGMP inspections. The agreement reached (see here and here) amends the Pharmaceutical Annex to the 1998 U.S. – E.U. Mutual Recognition Agreement, with a view to avoiding duplicative inspections and saving millions of dollars in repetitive inspections.

FDA has stated that they believe this “…initiative will result in greater efficiencies for both regulatory systems and provide a more practical means to oversee the large number of drug manufacturing facilities outside of the U.S. and EU.”

Mar 7, 2017

The Data Driven Reality of Clinical Trials

Metrics provide the foundation for 
business intelligence for clinical trials, 
measuring success or failure. 

by Craig Morgan

Head of Marketing


Why are metrics important in starting clinical trials? This question may seem counter intuitive, as we are exposed almost daily to the dire performance of clinical trials and their spiraling costs resulting from incurred delays.

According to a recent study by KPMG (1), within the pharmaceutical industry, the return on R&D expenditure has fallen from an industry average of approximately 20 percent 20 years ago, to 10 percent now, with the average cost of developing a drug rising during that period at a rate 7.4 percent higher than inflation, with the increasing costs of conducting clinical trials responsible for most of this increase (2). It is estimated that it now costs upwards of $2 billion dollars to bring a new drug to market (3).

Mar 2, 2017

2017 Marks Official “Go Live” For Medical Device Single Audit Program (MDSAP)

MDSAP reduces regulatory burden on
medical devices while demonstrating
compliance at the same time.

by Marci Crane

Marketing Communications Specialist

For medical device manufacturers who plan to sell one or more products in Australia, Brazil, Canada, Japan and/or the U.S., the Medical Device Single Audit Program (MDSAP) is a valuable option for reducing regulatory burden while simultaneously demonstrating compliance against all regulations stipulated by the respective regulatory bodies of participating geographies.(1) According to the U.S. FDA’s MDSAP FAQ page “The MDSAP…is a program that will allow the conduct of a single regulatory audit of a medical device manufacturer’s quality management system that will satisfy the requirements of multiple regulatory jurisdictions.”(2)

Mar 1, 2017

Supplier Approval Challenges Under FSMA

The Food Safety Modernization Act (FSMA)
is posing many challenges for food manufacturers
and those who supply ingredients to them.

by Erika Miller

Food Safety Specialist

D.L. Newslow & Associates, Inc.

As a food safety and regulatory consultant, I work with diverse clients who face many different challenges with Food Safety Modernization Act (FSMA) implementation. The ones that are the hardest to address fall into the intersection between company policy and regulatory requirements. Supply-chain approval is a major challenge for many larger corporate clients, as well as smaller clients who must remain flexible to maintain profitability. The requirements of the Foreign Supplier Verification Programs, or FSVPs, will soon add another layer as some compliance dates start as soon as May 30, 2017. The largest corporations have the earliest compliance dates, and although these organizations may have deep pockets they also have many facilities - which can present a major implementation challenge.

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.