Compliance Zen

5 Helpful Data Integrity Resources

Looking for reliable, "how to" information around data integrity on the web can be a bit of a challenge. One man's "data integrity" is another man's "data quality" is another man's "data governance."  Without delving into the minutiae of each of these perspectives, I thought I'd offer up five of the resources I frequently call upon when conducting data integrity audits and data integrity training.

 

MHRA Inspectorate Blog on cGMP Topics

Recently, the UK's MHRA has run a series of blog postings on data integrity - what it is and what it ain't from the regulators perspective.  Here are the three worth reviewing:

• GMP Data Integrity: A New Look at an Old Topic, Part 1
• GMP Data Integrity: A New Look at an Old Topic, Part 2
• Inspecting Clinical Trials - the Trial Master File

The last one is of particular importance because so often cGCP compliance gets the short end of the stick when it comes to public data integrity enforcement.  While GMP warning letters get media attention, when clinical data integrity fails, firms can actually go out of business as FDA and other regulators reject significant parts of submissions such as multiple investigator sites or send back complete response letters that jeopardize investments and raise the ire of shareholders.  Clinical data integrity issues don't make the news often, but just one clinical trial with poor data integrity can easily cost a company years of effort and millions of dollars down the drain.

 

FDA Guidance on BECS Computerized System Validation

If you've been wondering why people are reopening and reviewing FDA's 2013 guidance, Blood Establishment Computer Validation in the User's Facility, then the short answer is that it offers fairly concise information and guidance on what FDA expects around modern computerized system validation when it comes to testing and ensuring data integrity.  Be aware that way back in the preamble to 21 CFR 11 Electronic Records; Electronic Signatures, question #65, FDA strongly suggested that this guidance (the draft version at least) was essential reading for all industries.

 

Responsible Conduct of Research at Northern Illinois University

This collection of webpages includes a nice summary of data integrity control points around data collection for scientists and researchers. It includes elements of both quality control and quality assurance, and provides additional reference documents.

 

HHS HIPAA Security Series

Whether your organization is regulated by HIPAA or not, a review of the HIPAA Security Series #4 Security Standards: Technical Safeguards newsletter from 2007 is well worth your time. The 17-page newsletter walks through specific technical security safeguards to put in place and test around data; safeguards that look remarkably (or not so remarkably, depending on your perspective) like those found in 21 CFR 11, Annex 11 and multiple guidance documents.

 

FDA's Application Integrity Policy - Points to Consider

Primarily used for submission-related data integrity concerns, parts of FDA's Application Integrity Policy are important to review regardless of where you sit on the cGXP continuum.  In particular, review FDA's Points to Consider for Internal Reviews and Corrective Action Operating Plans (caution: this FDA link can sometimes take forever to open). Even though this is from 1991, there is a lot of good information within this section of the policy (e.g., it's an oldie but a goodie).

 

Of course, this all presumes you haven't already bookmarked Cerulean's resource library for data integrity-related articles, case studies, interviews, and so on.

Best 40 Blogs on FDA

FDAzilla has put together a great list of the top 40 websites (and tweets) in the world on the FDA.  Happily, high on the list is Compliance Zen:

#8: Compliance Zen - Written by compliance guru John Avellanet, this blog provides insights into “lean compliance,” QbD, audits/inspections, and other leadership tactics.

Read the full list here:  http://blog.fdazilla.com/2011/02/top-40-websites-and-tweeters-on-the-fda/

Mentioned in the same top ten company as Mark Senak's Eye on the FDA, the FDA Law Blog, and the agency's own Transparency Blog, I'm quite humbled that Compliance Zen has made it so far.

I guess not writing in "corporate-speak" has its benefits....  *grin*

On a complementary note, I'll be hosting a rapid run through of the most helpful websites for medical device professionals in regulatory compliance on February 23rd for FOI Services.  You can learn more about the presentation, 60 Websites in 90 Minutes: Sites Every Device Professional Should Know, on the FOI Services page:  http://www.foiservices.com/tc-docs/moreinfo/feb2311.html.  I hope to see you there.

And to the readers who follow Compliance Zen and my lean compliance consulting work - yet again, I thank you.

A Guide for, and From, the C-Level Executive

Agnes Shanley, Editor-in-Chief, of Pharmaceutical Manufacturing and PharmaQbD, has published a very nice review of my new book, Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine.  Also accompanying the review is a brief interview she did with me on why I wrote the book and how I hope readers in the biopharma and device industries will be able to benefit.

She cites the book as perfect for every C-level and vice president executive on your list.  Ms. Shanley writes "Avellanet offers concrete examples and the book is engaging and very well written."  She notes that Get to Market Now! directly tackles the lack of senior management interest and engagement in compliance:

"This book offers compelling reasons [for proactive compliance, quality by design, risk management, etc.] from someone who understands the senior management position.  As long as the industry fails to take the holistic, cross-functional view of regulatory compliance, risk management, and operational excellence, industry will continue to see consent decrees, product recalls, and tremendous waste.  Given drugs coming off patent, and the impact of healthcare reform in the US and price controls in Europe, can this continue much longer?"

To read the full review of Get to Market Now!, listen to the interview, and read some of the chapter excerpts, visit PharmaQbD or the book's dedicated website at www.Get2MarketNow.com.

New FDA Compliance Resource Published

My new book, Get to Market Now! Turn FDA Compliance into a Competitive Edge in the Era of Personalized Medicine, has been published and released nationwide.

Here are just some of the details:

• 25 figures, diagrams and tables
• 15 different checklists and templates to ease implementation of recommendations in the book
• 113 specific tactics to strengthen compliance and improve R&D productivity
• 7 overall strategies to balance bottom line profitability with patient safety, better medicinal product efficacy, and simpler compliance
• 16 case studies and real-world examples

Get to Market Now! (342 pages, softcover, ISBN: 978-1-934899-12-0, Logos Press) covers all aspects of new medicine design and development, from preclinical through regulatory submissions, quality systems, regulatory affairs, and postmarket monitoring.

Feedback from preliminary review copies has been incredibly positive. "Simply brilliant" and "Tells you exactly what you need to know" are examples.  As reviews are formally published in various industry journals, I'll make sure to publicize and link.  And, as a result of the preliminary reviews, I've already been asked to serve on two additional industry boards.

If you'd like to order, you can get online or in dozens of bookstores around the country (including the BIO bookstore at the 2010 BIO conference).  Here are a few direct links to buy the book online:

• Amazon.com
• Barnes & Noble
• Logos Press (this is also for customized orders although I believe 25 copies is the minimum for customizing the book to your organization)

And don't forget to check out the book's exclusive website at www.Get2MarketNow.com, which includes a downloadable PDF of the introduction and first chapter of the book.

If you have any comments or suggestions after reading the book, please email me.  I look forward to reading any reviews you post online at Amazon or elsewhere.

Featured Reading: Training for Dummies

With many quality systems management reviews including an assessment of organizational training needs, my featured reading choice is one of the best books on training I’ve found in 20 years:  Elaine Beich’s Training for Dummies .

The beauty of this book is its simplicity.  For the busy executive faced with leading an upcoming presentation or training session, the book is perfect for finding just the right amount of information to improve your game.

And for compliance executives tasked with continual improvement, the philosophy of the author should appeal:  “The purpose of training is to improve performance” (p. 260).

Three parts of the book I’ve found helpful over the years when I give corporate workshops and training:

·         How to determine if there is a good reason to conduct actual training (versus coaching, e-mailing information, presentations, etc.);

·         How to set reasonable objectives and get employees engaged; and

·         How to create effective visuals, start and end sessions on strong notes, and calm your own anxiety.

Throughout are many tips on improving effectiveness—something crucial to improving performance, compliance and competitiveness.

Skip the webinars and teleconferences on “effective training” and spend less than $15 on Training for Dummies .  You’ll soon know why everyone else can’t get good quality systems training.

Featured Reading: Made to Stick

 

Would compliance seem such a chore to so many if quality manuals, security policies, records management procedures and audit reports were straightforward with simple, clear actionable takeaways?

That question hovers in the background the more you read through one of the best business books written in the past five to ten years, Made to Stick .

Drawing upon urban myths, corporate mantras and advertising slogans, Stanford University professor, Chip Heath, and former Harvard Business School researcher, Dan Heath, lay out what makes an attractive idea last and what makes a good idea fade.

Of particular help are the “clinics” in each chapter.  These pick a real-world concept that most readers will be familiar with (anti-smoking campaigns, for instance), and show how, using the techniques they’ve outlined, different groups have been able to either make the message memorable or forgettable.

Made to Stick is a necessity for any business leader, but its underappreciated value is for the compliance executive.

After all, assuming the content is the same, which sounds more enticing:  “Our  Quality by Design Strategic Initiative” OR “How We’ll Go from Lab to Market in 7 Years”?

Featured Reading: The Speed of Trust

 

A 2005 Harris poll revealed that only one-third of employees believe that their managers act with honesty and integrity.  As author Stephen Covey points out in his latest book, this lack of trust is the context in which executives must lead.

My featured reading, Covey’s The Speed of Trust , is a study in how trust influences the bottom line of corporations.  Throughout, Covey develops thirteen leadership behaviors that establish and grow trust among team, colleagues and departments in a company.

Two of these behaviors are of particular relevance to compliance and quality systems:

Behavior #9:  Clarify Expectations

Rarely are expectations clear or shared; they must be discussed and negotiated in the open.  The wise leader will recognize that even once expectations have been clarified and agreed upon, he or she must repeatedly communicate them.

Behavior #11:  Listen to Understand

I’ve often heard that we spend half our time talking and the other half waiting to reply.  Covey points out that active listening skills—really trying to understand—are a hallmark of a good leader.

To build trust in your compliance leadership and plans, learn The Speed of Trust .

 

Featured Reading: Design for Six Sigma

 

If your organization is Six Sigma focused, the new product development methodology outlined in this book is a necessity.

If you are not Six Sigma focused but are seeking ideas on how to speed your development and lower costs, consider reviewing and adopting some of the tactics in Design for Six Sigma .

And if you are looking for help implementing the FDA’s Quality by Design initiative, this brief book should give you much food for thought.

Broken into nine chapters, the book outlines the overall strategy for implementing Six Sigma in a product design environment.  Along the way, the most relevant tools and statistical methods are highlighted.

Every chapter ends with a concise “manager’s checklist” of the most important concepts from the chapter (something that I’m trying to adopt for the book I’m currently working on).  Other reviews of this book have focused on how it is not an in-depth resource on applying Six Sigma to product development; I rather like it's tight, summary points.  If you're looking for the textbook on Six Sigma and new product development, this is not the book; if you're looking for a quick refresher you can skim and look for specific techniques, this is perfect.

While most of the book is applicable to firms under US FDA or other HHS regulation, the examples are almost entirely drawn from the consumer products industries.  The usual suspects from any write-up on Six Sigma are all present—Motorola, GE, and so on.

All round, the Design for Six Sigma is a good read for any executive, especially those in research, development and commercialization.

Featured Reading: Sun Tzu for Execution

Steven Michaelson has followed up his bestseller, Sun Tzu For Success , with this excellent book on leadership skills and competitiveness.

There are five sections of the book, corresponding to the main thrusts of Sun Tzu’s Art of War:  Simplicity, Alignment, People, Flexibility and Strengths.

 In his Simplicity section, Michaelson points out:

·         complexity is expensive

·         people understand and execute simple ideas

·         celebrate and reinforce behavior you want to see (read my Regulatory Affairs Focus article, “Positive Enforcement,” for a strategy that draws on this for compliance).

 The Flexibility section includes recommendations on:

·         dealing with employee turn-over

·         drawing the line on process details

·         decision-making guidelines.

The other three sections have similar short, easily adopted techniques, suggestions and case studies.

The final section, Towering Strengths, is the weakest if only because so much business literature today covers the concepts of market differentiation ad nauseum.

While you may not want to share Sun Tzu For Execution with your staff, you’ll definitely want it in your executive library. 

Featured Reading: Writing to Learn

 

For every business executive, there comes a moment when you realize that your polices, your procedures—even your memos and reports—have a fundamental flaw; a deep-rooted problem that invariably ends in:

·         Audit findings

·         Poor compliance and adherence

·         Personnel and training troubles

·         Constant rework

·         Endless meetings

·         Loss of time, effort and money.

The crux of the issue?  Poor writing.  Not the poor writing you’d find in an amateur’s first novel or a teenager’s angst-ridden love poem, but writing that lacks three specific characteristics:

1.       Clarity

2.       Accuracy

3.       Brevity

In Writing To Learn —a collection of essays covering different writing types (technical writing, corporate reports, scientific methods, etc.)—William Zinsser advises:  “the reader should be given only as much information as he needs and not one word more” (p. 34).

Think about the polices, the procedures, the reports you’ve seen.  Was every word, every sentence really necessary?  Was accuracy counterbalanced with brevity?

Suggest Zinsser’s Writing To Learn to your staff.