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CO-LOCATED EVENTS

Speaker

Ayhan Balku

Senior Sales Director Europe, Kneat Solutions

I am an accomplished Senior Sales Executive with over 20 years of proven success in generating and increasing revenue. My passion lies in expanding existing business units and successfully developing and entering new markets and business segments.

My expertise covers the DACH region (Germany, Austria, Switzerland), Europe, Asia, and the Pacific.
I am recognized for consistently delivering results in demanding and competitive environments, particularly within the SaaS sector and through Value/Solution Selling.

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Session

Digitizing Validation — Driving Efficiency, Compliance, and Quality in Pharma Manufacturing

Solution Study

Monday, September 22

12:20 pm - 12:45 pm

Live in Berlin

Less Details

Validation is a cornerstone of pharmaceutical manufacturing, ensuring compliance, product quality, and ultimately patient safety. Traditional paper-based processes, however, are often time-intensive, error-prone, and difficult to scale. With regulatory frameworks becoming increasingly complex and operational demands rising, life sciences organizations are re-examining how validation is approached. This session highlights how digital validation is reshaping the pharmaceutical landscape. By replacing paper with compliant, data-driven systems, organizations are achieving greater efficiency, consistency, and reliability across global operations. Examples from leading industry adopters will illustrate how a digital-first approach strengthens compliance while reducing risk and cost. In this session you will learn more about:

  • Regulatory compliance as a driver for adopting digital validation and ensuring audit-ready, tamper-proof records.
  • Process efficiency through standardization, cost reduction, and streamlined workflows across sites.
  • Lifecycle management of validation projects, from commissioning and qualification to continuous process improvement.
Presentation

Company

Kneat Solutions

Kneat Solutions is a proudly Irish company, headquartered in Limerick, Ireland. Kneat’s in-house team designed the digital validation platform, Kneat Gx, which digitalizes the entire validation lifecycle, enabling companies in highly regulated industries to develop and deliver therapies as efficiently as possible—without compromising quality or compliance. Trusted by eight of the world’s Top 10 Life Sciences companies, Kneat Gx is used by tens of thousands of validation professionals worldwide. Implement, use, and scale Kneat Gx across an unlimited number of sites to harmonize your processes, accelerate speed to market, reduce validation cycle times by up to 50%, and enhance data integrity posture.
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Colocated with
Pharma Maintenance Europe 2025 is part of the Smart Manufacturing & Industry 4.0 Event Series. You can find more events here.
Date
September 22 – 23, 2025
Location
Maritim proArte Hotel
Friedrichstraße 151, Dorotheenstraße 65
10117 Berlin
Phone
+49 (0)30 52 10 70 3 0
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