Carsten Holm Pedersen

Global Technology Partner

"Digital manufacturing strategies are essential to increase the operational maturity of pharmaceutical manufacturers"

Carsten has more than 20 years of experience as a Biotech Automation Specialist and Pharmaceutical Manufacturing IT Architect. He develops digital manufacturing strategies and digital facility concepts.

Carsten has delivered corporate and site manufacturing IT strategies for global pharmaceutical manufacturers. Further, he has developed numerous automation and IT concepts for pharmaceutical facilities.

He has a Masters in engineering in biotechnology from the technical university of Denmark and TOGAF®9.1 certification in enterprise architecture.

What's your view on the industry?

The pharmaceutical industry is struggling to go digital. In many cases it still focuses on deploying key applications such as ERP, MES, LIMS, and CMMS. Generally the automation level of these applications are low: there are many hybrid electronic/paper flows. Manufacturers must be more ambitious if they want to be best-in-class manufacturers.

The complexity of aligning global and local business processes and applications is significant. Enterprise architecture will be the key to tool for managing this, but few manufacturers have established enterprise architecture to support the digital transformation. Without sound enterprise architectures large manufacturing organizations will not be able to establish digital manufacturing processes for the foreseeable future.

At the same time regulators are increasingly pushing manufacturers to be more data driven. This has come to a point where requirements for regulatory compliance and operational efficiency must be balanced throughout the IT architecture: applications can no longer focus on either regulatory requirements or business requirements and applications no longer operate on their own. Manufacturers need to establish common data models as they are the foundation for a series of solutions. Common data models are key to operational excellence in general, and release by exception and continued process verification more specifically."

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Expert in:

  • ISA-88, ISA-95, ISA-99, GAMP5, and TOGAF
  • Manufacturing Execution Systems (MES)
  • IT Compliance and Data Integrity
  • QBD and Risk based control strategies
  • Enterprise Manufacturing Intelligence (EMI)
  • Life Cycle Management
  • Electronic Batch Reporting (EBR) and review by exception
  • Continued Process Verification (CPV)
  • Process Analytical Technology (PAT)
TechTalk

How can data integrity bring you closer to digital transformation?

While other manufacturing industries discuss Industry 4.0 and Big Data, pharma manufacturers are securing the integrity of their regulatory records.

Read Carsten's article

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