Newsletter banner - WLH  

How to Create a Culture of Compliance for Good Documentation Practices


pharma congress  

Meet us in

Washington, D.C. 

WLH Consulting, Inc.

will be at the

Thirteenth Annual Pharmaceutical Regulatory and Compliance Congress

November 5-7, 2012

Grand Hyatt,
Washington, D.C. 
Find us in the

Exhibit Hall


Click to go to the conference website.


Rx for Compliance

May, 2012

Creating a Culture of Compliance with Lessons from NASA and the OIG


August, 2011

February, 2011
Optimizing Sales Performance with Field Based Monitoring

October 2010

Cross-Functional Alignment for Compliance Program Improvements  


May, 2010

Compliance Program Improvements for Reducing Risks


Pharm Rep

Inspect What You Expect:   Field Based monitoring programs can help companies avoid problems before they start

To see additional Compliance Publications from WLH Consulting, Inc. please click here.
Featured Offering

Learn more about
I GLASS Field Based Monitoring Program™


This program proactively meets the requirements of recent CIAs for field force monitoring and is a comprehensive solution for training, coaching, monitoring, and reporting compliant field behaviors.


Call 954-385-0770 or contact WLH to arrange a live demonstration.


Join Our Mailing List

With the high level of scrutiny on all pharmaceutical activities, sales groups need disciplined and diligent documentation practices (e.g., recording business plans, call notes) more than ever. Even when sales activities are compliant, if they are improperly documented, they can result in civil and criminal penalties.


The current methods employed by most companies to train and reinforce good documentation practices are not effective at mitigating this risk.  Just sharing federal regulations and corporate guidelines on PowerPoint training slides does little to change behavior.  Real behavior change takes place when the collective beliefs and values that determine behavior are changed (i.e., the organization culture)[1].  Therefore, to change documentation practices, every individual needs to believe that these practices are important for limiting the exposure of the organization to risk.  You need to build a culture that supports both compliant sales behavior and good documentation practices.

WLH recommends the following approach to create this culture:


  1. Perform a risk assessment to identify areas of vulnerability or potential scrutiny and determine how best to proactively address these.  Include all forms of business documentation and include people at all levels of the organization in your initial assessment.
  2. Identify what is meant by "desirable" and "undesirable" documentation practices.  Identify examples of what "not to do," best practices, and "grey areas" for group discussion and learning.
  3. Involve all levels of the organization in the change management effort to ensure "buy-in and ownership" of the change effort.
  4. Develop a disciplined communication and learning cascade.  Customize training to meet individual and group needs and cascade learning throughout the organization.
  5. Use learning best practices to produce behavior change. Learning programs should include opportunities to workshop scenarios and receive proper feedback to assist with the learning transfer to the real world.
  6. Identify "reinforcing experiences" to help support learning. Our experiences shape our beliefs, beliefs drive action, and action produces results[1]. Therefore, leaders need to create experiences that will shape and reinforce desired beliefs.
  7. Effectively monitor behavior and create a closed loop reporting system. This conveys the notion that good documentation practices are an ongoing expectation and enables responsiveness to potential issues.
These seven steps are designed to help sales leaders create a culture for good documentation practices.  By first defining and then using behavior based training to convey expectations, leaders can shape documentation practices.  Through effective monitoring and closed loop reporting, expectations will be reinforced, thereby mitigating risks on an ongoing basis. 



[1]  Connors, R. & Smith, T. (1999). Journey to the Emerald City. Prentice Hall Press: NY 


Wendy Heckelman, Ph.D.
WLH Consulting, Inc. 







WLH Consulting, Inc. has twenty years of experience consulting in the biopharm industry.  We combine this with our expertise in organizational and individual assessment, behavioral-based training, cultural change, and cross-functional alignment to provide recommendations and practical solutions to our compliance and commercial clients.
WLH Consulting Logo