iSpeak Blog

The Culture Club: Transparency – Part 2 of 4

Michelle Vuolo
Levi Schenk
Andre L. Walker, CPIP
Brandi M. Stockton
The Culture Club: Transparency – Part 2 of 4

We are The Culture Club, a self-formed cross-COP group of individuals who came together to discuss challenges encountered as we transition quality and validation into the digital world and identify ways to influence cultural changes needed within our industry to better enable innovation. As we are not all from the same COP, we first need to establish a way to connect and collaborate with all members of ISPE. This blog is the second in a series of four intended to explore how we can rethink the way we support and inspire one another as we reimagine quality and validation in a digital world.

We started episode 1 with an introduction to the culture club and our desire to influence the cultural shifts needed to enable digital innovation in regulated space. We dug into the 80’s movie, The Breakfast Club, to illustrate how realizing differences, and letting go of them can help you act in a new way. We suggested that you start becoming familiar with, and leveraging, digital tools. These next couple of episodes will dive into different aspects of the cultural shifts so that we can understand them and also look at small ways you can incorporate change into your daily working lives.

In this episode we will take a deeper look at what transparency means.

As technology innovation grows, we see the breakdown of data silos. The more that data sources are connected to digital tools, the better equipped we become to visualize data where it provides value and also the better we enable software tools to learn and improve on menial tasks. This is transparency. The perceived problem, which is prevalent in a regulated space, is that with increased transparency we provide more access but also increase risk.

One risk might be data theft or loss, however many companies are already spending a huge amount of resources to ensure data does not intentionally leave the company perimeter. This is known, yet still we create little locked rooms (real and digitally) inside that perimeter under the mindset that somehow our data needs to be kept from the larger workforce (yet we simultaneously want access to every other group’s data). The culture needs to instead shift to the risk/reward sectioning of information, where we look at the benefit of broad access to information against the threat of data theft, loss, or inappropriate use.

When we go digital, data is captured…all of it. If we go digital we will review and approve digitally, we will audit digitally, and we will defend compliance digitally. Transparency is scary. What “I" write can be used… anywhere. We are blurring the lines between work in progress (WIP) and final product. Let’s break down some of the perceived risks, actual risks, and highlight how we might mitigate them.

Perceived Risks Actual Risks How Mitigated
Information in the wrong hands. A subset of people may have access to information and spend time digging into data not relevant to their job function.
  • Access controls can ensure access is granted to the right people.
  • Audit logs around data loss prevention

Legal and/or compliance issues due to

  • Inappropriate and unprofessional comments.
  • Preliminary discussions on GxP issues are taken as official and approved.
Same as perceived risk. Training. This should already be a part of any good GxP Awareness or Data Integrity program.

Dead ended information not getting addressed.

There may be comments that have been written but not followed up.

Value of getting more information and context outweighs the risk of potentially having a documented path without conclusion.

This should be the role of the reviewer to ensure comments/questions in the record have been addressed.

Post-it notes are the same as comments.

We’ll be stepping back from gmp-isms, such as approvals and quality oversight. None, approvals and quality oversight is still applicable. We are not changing requirements, only how they are met.
Can't control what we show; everything is discoverable.
  • Value of getting more information and context outweighs the risk of potentially providing transparency to additional information.
  • Potentially additional time investigating unnecessary issues
  • Potential audit observation
Training should be a part of the cultural training associated with digital transformation. The same holds for whether we are paper based or digital; we should understand that documentation, in any form, should be kept professional and on-topic.
Can’t perfect what we present. Digital tools allow for curated data dependent upon the data consumer. An approved record is based on a particular data set (has context).

For different quality records, there is a continuum of formality and transparency that is characterized by a commensurate level of scrutiny of the documented information. The graphic below represents the traditional line of documentation against the same information as a digital process and repository. While digital can have a higher barrier to entry for quick communication (configuring the digital space), efficiency is gained as we continue up the level of control because the necessary level of control is built into the digital tools. GXP content is created real time, bit by bit, over time, with the appropriate Quality oversight always present.

GXP content is created real time, bit by bit, over time, with the appropriate Quality oversight always present.

What can you do today?

  • Create channels vs private team sites so that the information you are exchanging is public to whoever is interested. Collaborate with anyone interested.
  • Train. The world is changing. Start using digital tools for informal uses to gain experience and comfort with the features.
  • Challenge your existing teams use digital tools!

Join the culture club. Embrace the change, enjoy it with us, and add your experience to the transformation. Choose the change.

As we stated in the beginning - this is the second in a series of four. It is the beginning, an introduction, a warm up… Make little changes today for ongoing culture shifts. Start this practice now so that it becomes routine; routine to question the status quo, routine to identify the objective of your actions (without making a copy of the last project, then finding and replacing each reference to the old project), and routine to think digitally and reimagine how we use all this data!

Until next time friends

The Culture Club: Be the Change – Part 1

The Culture Club: Upskilling - A Skill of Survival – Part 3

The Culture Club: Wrapping it up - Part 4 of 4

-The Culture Club

iSpeak Blog posts provide an opportunity for the dissemination of ideas and opinions on topics impacting the pharmaceutical industry. Ideas and opinions expressed in iSpeak Blog posts are those of the author(s) and publication thereof does not imply endorsement by ISPE.