What's New at CQS


**Just Added**

Bridging Chasms In Equipment Qualification And Software Validation

Click here for a System Requirements Document Template for equipment qualification and software validation.


Other Resources:

"Developing GCP SOPs: Common Pitfalls And How To Avoid Them"

Click here for a template that serves as a starting point to guide you through the process of developing clear and concise SOPs.   

"Employing GMP Techniques In GCP For More Robust, Compliant Clinical Studies"

Click here to download a simple Excel spreadsheet tool that can serve as a starting point to guide you through the process of:

1) Outlining critical attributes and data (using the study synopsis) that must be obtained from the study
2) Classifying and prioritizing the risks associated with obtaining that data
3) Rating the severity and likelihood of occurrence and detectability of these risks
4) Developing a plan to mitigate any moderate or high-risk events




Employing GMP Techniques In GCP For More Robust, Compliant Clinical Studies
... We needed to identify critical data and attributes, determine potential risks, categorize and prioritize those risks, and propose how to mitigate and manage them. Our table began, with myself and my colleague, who shares a similar GMP background, taking the lead. We had done this before and we started right in, working from muscle memory. And then we stopped for a moment and looked up at the rest of the room ...

Many individuals sat with dazed looks, in a dull panic, not sure where to begin.
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6 Simple Ways To Get Millennials (More) Invested In QualityWhen he was home for the holidays, my 23-year-old son and I had intense, heated discussions about generational differences. We are still on speaking terms, but it got me thinking about how well we understand and value young people — and if we understand the people who make up our future workforce well enough to adequately train them. That is, are we doing everything we can to create a sustainable future workforce that feels valued and — just as important — is engaged, excited, and efficient (the “3Es”)?
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7 Steps To Properly Navigate An Event Investigation
A recently published article examining recent GMP inspection data from CDER (FDA’s Center for Drug Evaluation and Research) and MHRA (Medicines and Healthcare products Regulatory Agency) notes that “Deficiencies in investigations remains at the top of this list [of the most frequently cited observations] over the past four years. We as an industry cannot seem to get this quite right.” I agree. Here’s why.
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How To Optimize Your Stability Program At Each Phase Of Drug Development
A drug stability program that is above reproach is critical to successfully navigating the complexities of drug development. A well-managed stability program with thoughtfully constructed protocols demonstrates your lab and quality systems are in control.
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How To Bulletproof Your Quality Training Programs
It is not uncommon for FDA warning letters and notice of violation letters to pharmaceutical companies to note either a lack of training or the need to include training or retraining in corrective and preventive action (CAPA) improvements.
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The 4 Pillars Of A Voluntary QA Culture: How Does Your Company Measure Up?
The U.S. Food and Drug Administration (FDA) cites corporate culture as a root cause of many compliance issues. It also says a strong quality culture “can lead to sustainable compliance.”1 How can pharmaceutical companies encourage a quality culture that empowers employees to own quality, so they operate in ways that allow maximum performance and safe, effective products?

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How to Craft a Well-Written SOP
Many deficiencies identified in FDA’s 483s and Warning Letters can be traced back to SOP deficiencies—inadequately written, communicated, monitored, and/or enforced.Well-written SOPs provide clear instructions, avoiding deviations. With a reduction in deviation, organizations can maintain compliance, deliver a quality product, and ensure patient safety.

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"The Fundamental 5" SOP Training for Everyone
Quality experts know that SOP training has positive effects on a company’s performance and success. Yet senior executives can resist even a minimum amount of training,especially when they do not operate daily in a GxP environment.

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Building the Best Foundation for Your Training Programs
Today, we want to discuss elements that make for a strong foundation for such a program.Remember the goal is to maintain compliance while ensuring employees efficiently master required techniques and current operating procedures and protocols. 

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Bulletproofing Your Training ProgramsAmong the 40 GMP drug warning letters issued by FDA in Calendar Year 2015 for data integrity deficiencies, 12 (30%) made note of either a lack of training or the need to include training or re-training in corrective and preventive action (CAPA) improvements. 
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Five Lessons for Building a “Voluntary QA” Culture
Lesson 5: “Retail politics and campaigning for Quality”
As we come to the close of this election cycle (with much thanks and relief), today we delve into how “retail politics” can help Quality be more successfully integrated into everyday activities.

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Five Lessons for Building a “Voluntary QA” Culture
Lesson 4: “Be a part of the team ….”
In my role, I help companies remain compliant and people remain sane. At the core of this, I must be able to build trust and collaboration among many different people, and one way to achieve this is for me to build great teams.
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Five Lessons for Building a “Voluntary QA” Culture 
Lesson 3: “Think like a teacher”
Dictators don’t engage people they don’t focus on the “why,” only the “what.” They demand action, no questions asked. Educators, rather, engage people by focusing on helping them understand the “why” of Quality so they are better prepared and equipped to work on the “how.”

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Five Lessons for Building a “Voluntary QA” Culture
Lesson 2: Fire Prevention vs. Firefighting
Quality - like fire prevention - is everyone’s responsibility. What happens when only firefighters (or Quality departments) are responsible? They run all over looking for fires, always on alert and in a constant state of crisis. An alternative is to educate people and offer well thought-out education programs … 

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Five Lessons for Building a “Voluntary QA” Culture
Lesson 1: Think like a Coach instead of a Cop

Responses to our last post were quite positive (Thank You.), so I wanted to provide more details around building a “Voluntary QA” Culture. The first lesson: “Think like a coach instead of a cop.” 
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Five Lessons for Building a “Voluntary QA” Culture
Do we really have to do that? Isn’t there some sort of "QA-lite" solution?

Having been asked this question many times, I see it as a red flag, but to be fair, this question comes from people with the perspective that GMP is burdensome and as such translates to “Great Mounds of Paper.” 
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“Voluntary QA” Bulletproof Research Practices and Data Collection
A Fire Extinguisher in the Corner

A great article in January’s Nature spells out what I believe to be a new movement in Quality Assurance (QA). The article discusses “Voluntary QA” and how it can: 1) Improve overall data Quality and research practices. 2) Develop research processes that prevent issues before they happen. 


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