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.

Jan 17, 2017

Preparing for a US FDA Medical Device Facility Inspection

by Linda M. Chatwin, Esq. RAC

Manager Medical Regulatory Advisory Services

North America UL, LLC

First in a series of articles about how to prepare proactively for an inspection, how to prepare after the call that the inspection is imminent, and how to react during and after the inspection.

It is never fun to get that call – the one where the FDA lets you know they will be at your facility in a few days to give an inspection.

There are a number of things that once can do to be more prepared for that day, however, and preparation is key in minimizing not only the stress of the inspection, but also the outcome of it.

Jan 12, 2017

5 Tips for Bolstering Cybersecurity

Balancing patient data security 
and convenient access is possible

by David Jensen

Marketing Communications


Cybersecurity can be exhausting and difficult to control—even for IT pros. A security risk management executive at AbbVie Inc., discussed cybersecurity at the 2016 PDA/FDA Joint Regulatory Conference and offered some tips for how you can ramp up your organization’s IT security efforts.

Jan 10, 2017

5 Things I Learned about FDA Audits from its Sister in Compliance, the FCC

The unannounced FDA audit is a feared 
experience but these five tips can alleviate 
some of the stress.

by Anthony Rossi

Sales Operations Specialist


Before I came to work at MasterControl, I was an operations coordinator at a company called CaptionCall. CaptionCall provided telephone captioning to the hard of hearing, and because it was funded through federal taxes we were directly overseen by the FCC. While I was working at CaptionCall, I was directly involved in an audit performed by the FCC. The day of the inspection was one of the most stressful days in my career.

Jan 5, 2017

5 CAPA Best Practices You Should Be Doing Now

Clinical research pros can learn 
from manufacturing when it 
comes to leveraging CAPA.

by Cindy Fazzi

Editor, MasterControl Insider

Let’s play a quick word association game. If I say CAPA, I’m betting someone will say manufacturing. The concept of corrective action and preventative action is indeed associated with product quality in manufacturing because of long-standing regulations and standards requiring CAPA in that sector. However, MasterControl’s Patricia Santos-Serrao says you can and should leverage CAPA principles in clinical research.

“If you work in clinical research, you can use CAPA strategies that have been tried and tested in manufacturing and adopt them for your specific needs. The CAPA framework for investigating a quality issue is applicable in clinical as much as another area,” said Santos-Serrao, MasterControl’s director of clinical and regulatory solutions for the pharmaceutical, blood, and biologics industries. She shared five CAPA best practices that you can adopt in clinical trials in an article she wrote for Pharmaceutical Commerce. 

Jan 3, 2017

How to Minimize Protocol Deviations

Not all protocols are 
well written or error-free.

by Laurie Meehan

Social Media Manager

Polaris Compliance Consultants, Inc. 

Year in and year out, protocol deviations are the most common FDA site inspection finding. Why does this keep happening?

If you’ve seen FDA’s Inspectional Observation Summaries, you know that in 2015 the most frequently cited violation in clinical research by far was “failure to conduct research in accordance with the investigational plan.”  Do you know this also topped the list the year before that?  And the year before that?  In fact, deviating from the protocol has been the most common observation every year for the last decade.