Tag Archives: Data Integrity

Petter Moree – Industry Principal, OSIsoft

A conversation with Petter Moree, Industry Principal at OSIsoft.

Petter MoreePetter joined OSIsoft in October 2015 as the Industry Principal for Life Sciences, Food & Beverages and Specialty Chemicals, ensuring these markets obtain optimal value through their use of the PI System. Petter is based in southern Sweden and works globally with most of the leading pharmaceutical companies and strategic partners in the OSIsoft partner ecosphere.

What do you hope the audience will learn from this webinar?

I hope the audience understands the importance of operational data in the pharma industry. Operational Data addresses several crucial challenges; from time to market in R&D all the way to the ability to make data driven decisions in QbD and PAT, but also covers regulatory aspects such as Data Integrity and CPV.

What discussions do you look forward to having with the audience?

How others have done global rollouts of data infrastructure, what business cases they have solved, compliance questions such as data integrity and Electronic Batch Recording and Review by Exception.

Keeping in mind my background in statistics and data science for the pharma industry, I would be happy to receive questions related to analytics and tools and solutions for operational data access.

What do you enjoy most about your role?

The ability to meet many skilled and talented people who really challenge and educate me. As well as being part of the digital revolution in the industry and having an opportunity to influence and contribute to it which is very exciting.

How did you get into the industry?

It started at the Umeå University where I was introduced to the Design of Experiments and Chemometrics, and I later acquired a position which allowed me to apply and educate the pharma industry on these topics. I think the reason that I got into stats and match was that during my studies at the university I enjoyed solving problems more than being in the laboratory.

Where is your favourite place in the world and why?

Wherever I am, I most enjoy being with my family, and in particular doing something all of us enjoy, for example alpine skiing in winter or fishing in the mountains in the summer.

Join Petter Moree on 12th September for a webinar entitled The Secret Formula For Becoming A Data Driven Decision Maker  at 3PM London/10AM New York

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Fixing What Isn’t Broken: Optimizing the Pharmaceutical Supply Chain Using Operational Data

In heavily-regulated industries, the path of least resistance often means that processes stay the same, and the pharmaceutical industry is no exception. Between red tape and high-margin drugs that are brought to market under short-term patents, pharmaceutical companies must quickly recoup research and development costs while mitigating risk, leaving little incentive to proactively rework supply chain processes.

In the midst of this, many brands outsource the production of drugs, which relinquishes control of the production process. Without access to concrete data and information from these remote facilities, drug companies and contract manufacturers (CMOs) cannot confidently make necessary changes to prevent issues or improve the process, especially if it could jeopardize or stall production.

Now, progressive CMOs are realizing the value of operational data and, by implementing the right infrastructure, are giving drug companies unprecedented visibility into the production process. With these near real-time insights, the drug manufacturing supply chain model is on the brink of massive shift that will allow companies to bring drugs to market faster.

Development and Regulation
Quality is the number one concern of every drug manufacturer and, with every production run there are numerous outside variables that can diminish that quality. Things such as machine functionality, temperature, and volume can significantly alter a drug’s potency, effectiveness, or even availability. However, when production is outsourced, there’s one major problem: Delegating responsibility is not the same as delegating accountability. Regardless of whether a drug is produced in-house or by a CMO, in the eyes of the consumer, the pharmaceutical company will always assume any and all production risks.

Previously, disparate data sources made it difficult for pharma companies and CMOs to use operational data to understand asset performance and other variables in the production process. Data integrity issues meant that collected data couldn’t necessarily be trusted, especially when that data was patched together using numerous systems. Without a single infrastructure, analysts were left to guess or manipulate data, calling data integrity into question.

Accountability and Control with Data
However, as the industry turns toward analytics, both CMOs and pharmaceutical companies are realizing that quality data is nearly as valuable as the product itself. When a pharmaceutical company can remotely gather real-time insights from a single source of truth within each CMO, not only does the brand have unprecedented levels of transparency, the CMO can demonstrate manufacturing efficiency and product quality. The right collection, storage, access to and consumption of operational data allows companies to make decisions that lead to more cost-effective production, a shortened time to market, lower consumer prices, and a higher quality product.

Contributed by Petter Moree, Industry Principal at OSIsoft

Join Petter Moree on September 12th for his webinar entitled The Secret Formula For Becoming A Data Driven Decision Maker for more information on best practices in driving a business value from real-time data and requirements for data management in Pharmaceutical Industry during the webinar

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