Over the past year, the emergence of COVID-19 has pushed the BioPharma industry to deliver faster than ever before, yet it can be hard for any industry to keep up with demand at such a high level. Keep reading to learn more about BioPharma compliance in the United States.
Our Thoughts on Compliance in BioPharma
At Eliassen Group and EG Life Sciences, we have posed a question to address this problem: “Is Agile the Answer to Big Pharma’s Digital Revolution?” We’ve also asked ourselves, “What if Continuous Compliance were possible in the drug industry?” We’ve held Lean Coffees and formed a working group to figure out if mixing Agile and BioPharma is the answer.
We have learned that there is great interest in bringing Agile practices to the BioPharma and pharmaceutical industry, but traditional companies with traditional processes and regulatory compliance challenges may be hesitant to change.
To think about fresh approaches, I spoke with Bob Fischer, Director of Agile Delivery & Training at Eliassen Group, and Tim Reaves, Technical Practices and Delivery Lead. We talked about why updating your process and shifting toward continuous compliance in BioPharma is crucial, and we wanted to share some of our biggest findings with you as a video:
In this video, we cover the importance of automation when it comes to compliance. Even if you think your compliance process runs smoothly, you may need to re-evaluate, especially if the process isn’t automated. Continuous compliance shifts the burden of responsibility for an audit from human beings to an automated pipeline, which Reaves describes as a “set of steps required to take something from Step A to Step B.”
How Continuous Compliance in BioPharma Works
In the case of continuous compliance in BioPharma, instead of a person moving code through the production process via a manual workflow, a properly configured automated tool can do that for you, while also preserving a record of the process that can be reviewed and, in the case of BioPharma and life sciences, improving patient outcomes and quality assurance.
Fischer says that companies with a manual process, including those within the biopharma and life sciences industries, may feel it is superior because they have more control, but “when you have a pipeline, you build in automation, and purpose of that automation is to execute whatever the policy is that you have.” The process starts by working with human beings, giving them agency in the outcome, and then specifically constructing a pipeline that handles the authorization for the group.
When getting started, it is important to keep in mind that continuous compliance can be implemented with in-house or commercial-off-the-shelf (COTS) tools, provided the software is scriptable. So the good news is that, in most cases, not only is continuous compliance in BioPharma possible for custom software, but it also applies to configured software.
The Benefits of Continuous Compliance in BioPharma
By making these changes, the results can be tremendous. As Reaves points out, pharmaceutical companies and other BioPharma organizations that have been slow to market in the past are turning to automation in manufacturing practices to get faster. In the long run, Reaves says, “It really can be a huge time savings, and time equates to money.”
Eliassen Group supports Biopharma firms in overcoming key difficulties, maintaining compliance programs, and accelerating the research, development, and delivery of life-changing medications and therapies to patients.
Interested in finding out more about how you can learn more about pipeline programming or update what you have to achieve continuous compliance in BioPharma? Learn about our Agile Consulting Services, our work with DevOps, and our experience in the Life Sciences industry.
About the Author
Written by Jim Damato
Jim Damato is a seasoned leader with 25 years of experience, taking initiatives from vision and strategy, through rollout and operations. He started as a software engineer in Silicon Valley and grew to lead product development teams before moving to solution engineering, engagement management, and coaching. Jim works with publicly-traded companies, quick-growing startups, and federal agencies. He is also an active participant in the Agile community, speaking publicly on Metrics, Complex Agile Implementations, Agile in Hardware, and Business Agility.