Efficiency Through Targeted Process Optimization in the Laboratory

Expert insights from biomedion’s Daten Doku Digital podcast

In this episode of DatenDokuDigital – The Pharma Archive Podcast by biomedion GmbH – biomedion’s Julian Weber and Dr. Philipp Krubasik discuss how laboratories in regulated life-science environments can significantly increase efficiency through targeted process optimization.

Their guest, Dr. Stefan Krügel, founder of Krügel & Partner and an experienced Lean Six Sigma Black Belt, contributes practical insights drawn from many years of hands-on project experience in laboratory and quality-critical organizations.

The conversation focuses on real operational challenges rather than theoretical concepts. It illustrates how structured process analysis, combined with purposeful digitalization, can deliver measurable efficiency gains while maintaining full compliance with regulatory requirements.

Why Process Optimization Has Become Essential for Modern Laboratories

Efficiency, compliance, and quality must be addressed together

Laboratories today face increasing pressure from regulatory authorities, growing data volumes, and limited availability of skilled personnel. Many existing workflows are historically grown, fragmented, and still rely heavily on manual activities. While these processes may meet basic compliance requirements, they often consume unnecessary time and resources.

Targeted process optimization helps laboratories systematically identify inefficiencies and eliminate non-value-adding activities. When implemented correctly, optimization improves turnaround times, enhances data integrity, and increases overall process transparency - all without compromising quality or compliance.

What Process Optimization Means in a GxP-Regulated Environment

Structured improvement instead of isolated digital initiatives

As emphasized by Julian Weber and Dr. Philipp Krubasik during the discussion, process optimization in regulated environments must follow a structured and controlled approach. Simply introducing new tools or software does not automatically improve efficiency.

Effective process optimization starts with a clear understanding of existing workflows and regulatory constraints. In GxP laboratories, improvements must support:

•    Data integrity and traceability
•    Audit readiness and documentation consistency
•    Controlled and validated system landscapes

Only when processes are clearly defined can digital solutions be implemented in a way that truly supports operational efficiency.

Four Key Elements of Successful Laboratory Process Optimization

Lessons learned from real-world best practice

1. Systematic Analysis of Existing Processes
Transparency is the foundation of sustainable improvement

Dr. Stefan Krügel highlights that many optimization projects fail because organizations underestimate the value of process transparency. A structured analysis of current workflows often reveals that a large proportion of laboratory time is spent on indirect activities such as searching for information, duplicating documentation, or manually transferring data between systems.

Creating transparency is therefore the first and most critical step toward meaningful improvement.

2. Purpose-Driven Use of Digital Technologies
Technology must follow process requirements

Digitalization plays a central role in modern laboratories - but only when applied with clear objectives. The podcast discussion underlines that digital tools must support defined process goals rather than dictate them.

Automated workflows, electronic documentation, and digital archiving systems can significantly reduce manual effort and error rates, provided they are implemented as part of a coherent process design and validated according to regulatory expectations.

3. Measurable Results Through Key Performance Indicators
Optimization success must be objectively verifiable

Meaningful KPIs are essential to demonstrate the effectiveness of optimization measures. Time savings, reduced error rates, and improved process stability allow organizations to quantify improvements and justify further investment.

Benchmarking also enables laboratories to compare current performance with industry best practices and identify additional optimization potential.

4. Change Management and Employee Involvement
People determine the success of process optimization

As discussed by the hosts and guest, even well-designed processes will fail if they are not accepted by the people who use them. Sustainable optimization therefore requires structured change management, transparent communication, and adequate training.

Early involvement of laboratory staff increases acceptance and ensures that new processes are not only compliant, but also practical and efficient in daily operations.

Practical Example: Efficiency Gains Through Digital Archiving

Reducing operational effort while strengthening compliance

One concrete example discussed in the podcast is laboratory archiving. Manual or fragmented archiving processes are time-consuming and prone to error. In contrast, structured digital archiving solutions reduce documentation effort, improve data availability, and support long-term compliance.

From an operational perspective, digital archiving is not merely a storage function. It is a critical element of efficient laboratory workflows and a key enabler for audit readiness and data integrity throughout the entire data lifecycle.

Conclusion: Process Optimization as a Strategic Lever for Laboratories

From operational burden to sustainable value creation

Targeted process optimization enables laboratories to work more efficiently, reliably, and transparently. As highlighted by Julian Weber, Dr. Philipp Krubasik, and Dr. Stefan Krügel, success depends on a structured approach that combines process analysis, appropriate digital tools, measurable KPIs, and effective change management.

For life-science organizations, process optimization is not a one-time initiative. It is a continuous improvement journey that transforms operational complexity into sustainable value - while fully meeting regulatory expectations.

How biomedion Supports Sustainable Process Optimization

Turning efficiency, compliance, and digital archiving into a competitive advantage

Targeted process optimization does not end with analysis and recommendations - it requires reliable, validated digital solutions that support regulated laboratory operations over the long term.

With Watcher, biomedion provides a GxP-ready platform for secure data management and long-term archiving that integrates seamlessly into optimized laboratory workflows. Watcher helps laboratories:

•    Reduce manual documentation and archiving effort
•    Ensure data integrity, traceability, and audit readiness
•    Manage growing data volumes efficiently and securely
•    Support validated digital processes across the entire data lifecycle

By combining structured process optimization with proven archiving and data management technology, laboratories can achieve measurable efficiency gains while maintaining full regulatory compliance.

Want to learn how Watcher can support your laboratory’s optimization journey?

Get in touch with the biomedion experts and discuss your specific requirements.

Tune In and Stay Informed

Hear the full episode for deeper insights, examples & next-step suggestions

🎧 Listen now: DatenDokuDigital – Episode #5 "The Challenges of Data Archiving: Legacy Systems in Pharma"

Whether you work in quality management, research, regulatory affairs, or IT, DatenDokuDigital offers valuable insights for anyone driving digital transformation in the pharmaceutical industry.

Subscribe now: DatenDokuDigital – The Pharma Archive Podcast by biomedion

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