we.CONECT: The Pop in your Job –  In your position as Associate Director, ITS Compliance at Sanofi, you say your Pop in hte Job is to find better ways to get the right results for compliance in your company. Which tasks or responsibilities would you name as particularly interesting? What is most exciting, and why does this make you passionate about your job?

Brian DiVasta: The most interesting part of my job of late is the interaction and collaboration with my global partners; being able to share best practices with colleagues at other sites, actually being asked to do so, is very humbling and tremendously rewarding.  As I spend more time working with quality and not against quality, I have more respect for the urgency of our work and the importance of compliance, but I still strive to do so practically and efficiently!

we.CONECT: At Pharma MES USA, you will be presenting your project on „Urgency and drivers for taking Data Integrity initiatives from a local to a corporate level“, together with your colleague Patricia Hebert. In the bigger context, where would you place your project? – „It’s a good example/case study for…“

Brian DiVasta: Collaboration; successfully implementing a DI program at the local or global level takes teamwork – very cliche, but true – it is impossible to succeed without representation and commitment from IT, quality (assurance and control), manufacturing, etc.

we.CONECT: What were the most important drivers for your project – functionality, speed, process optimization, security, user/customer satisfaction, cost, or maybe something completely different?

Brian DiVasta: Compliance – keeping up with evolving regulatory expectations and deploying best practices and improved technology to do so.

we.CONECT: Looking at the starting phase and the first pocs – Where do/did you see major accomplishments and success stories for achieving the overall project objective?

Brian DiVasta: Major successes started small; proving a tehcnical control on a single instrument in the QC lab, produding a single procedure from many…from the small success, you demonstrate the feasibility of the work and start to win over skeptics.

we.CONECT: What were the major challenges and how did you overcome them?

Brian DiVasta: Urgency – wanting to move quickly when a methodical approach was needed – we ran the risk of appearing to not make progress for quite some time, but the possible repercussion of a fast-paced and uncontrolled effort justified the patience and planning.

we.CONECT: Looking at the selection of use and business cases that are announced for the event: What sets your approach apart? What can other organizations learn from you?

Brian DiVasta: I don’t think our approach is different – but I think the working relationship is; Pat and I were for many years like oil and water – we were unable to mix without external force.  We have developed a very solid working partnership that relies on trust and respectul discourse – we dont‘ always agree, but we can find a common ground.  Using that partnership of ITS/Automation/Quality to influence change has been very successful.

we.CONECT: Looking at the future, which topics and trends with regards to data integrity and pharmaceutical compliance do you see in the upcoming 12 months? Into which direction will the topic evolve?

Brian DiVasta: I think we will see further expansion to the cloud, increased use of AI and machine learning, greater integration of smart devices and way more uncertaintly in how to apply and audit for compliance.  There is an opportunity for companies to set a course – define how they intend to use technology to drive compliance – challenge our regulators to keep up – come up with use cases and rationale for inclusion (or exclusion) of data from inspection.