Lifecycle Management for Adaptive Biotech Assets

Industry

Biotech / Life Sciences / Pharma

Scope

Managed Services / FAT / Bugfixing / Industry 5.0 / Modular Architecture

Timeframe

Ongoing - multi-phase engagement

  • 3

    Integrated Release Cycles

  • 100%

    Baseline Success Rate

  • 100%

    IP Clarity (Retained ownership model)

01

CLIENT

A global leader in the Life Sciences and Pharmaceutical sector, dedicated to advancing scientific discovery and biomanufacturing. The client operates at the forefront of Industry 5.0, integrating intelligent modular units into their critical production environments to enable flexible manufacturing.

02

BUSINESS NEEDS

As the client transitioned from development to operational deployment of their proprietary modular automation software, they faced the critical need for stability and reliability. They required a strategic partner to handle the rigorous validation process (Baseline FAT) and provide continuous, rapid-response engineering support to ensure these advanced assets operated seamlessly in a live biotech environment without disrupting critical workflows.

03

CHALLENGE

Maintaining high-tech distributed systems in a regulated environment presents unique hurdles:

  1. Validation Complexity

    Validation Complexity

    Conducting rigorous Factory Acceptance Tests (FAT) for complex, software-driven hardware modules to meet strict industry standards.

  2. Unpredictable Operational Issues

    Unpredictable Operational Issues

    The need for a flexible response mechanism to handle "bug fixing" and emergency support requests as they arise in real-time.

  3. Intellectual Property Stewardship

    Intellectual Property Stewardship

    Navigating a complex IP arrangement where the technology provider retains core IP ownership while granting the client non-exclusive rights.

  4. Distributed Systems Management

    Distributed Systems Management

    Maintaining stability across modular automation units within a regulated biotech production environment.

04

SOLUTION

We established a robust "Baseline Support & Lifecycle Management" framework, shifting from a transactional project model to a continuous partnership service. The solution entailed:

  • Structured FAT Execution
  • A systematic approach to Baseline FAT tests, ensuring every firmware and software release is validated before production.
  • Flexible Engineering Retainer
  • A "Mandays Package" model allowing dynamic consumption of hours for bug fixing, patches, or tests.
  • Emergency Response Protocol
  • A dedicated support tier for critical blockers to ensure minimal downtime for R&D and production.
  • Product-Based IP Strategy
  • Operationalizing a model where the client leverages assets while we maintain core IP, fostering a scalable ecosystem.

Łukasz Paciorkowski, CEO of A4BEE

In the era of Industry 5.0, building the software is just the beginning. The real value lies in reliability. By establishing a continuous support loop - from FAT validation to emergency bug fixing - we gave our client the confidence to scale their modular infrastructure knowing that a dedicated expert team is always watching their back.

Łukasz Paciorkowski

CEO A4BEE

Technology used

Modular Automation Framework Industry 5.0 Architecture Issue Tracking Systems Remote Debugging Tools Embedded Systems Control

05

OUTCOME

The transition to a managed support model stabilized the client's component ecosystem. It provided a unique balance of technical reliability, financial control, and rapid response capabilities essential for high-stakes biotech manufacturing.

  • Operational Stability
  • Successful execution of multiple Baseline FAT rounds ensured high-quality releases.
  • Cost Predictability
  • The package-based model provided budget control with on-demand access to premium resources.
  • Risk Mitigation
  • Immediate addressing of software bugs and emergencies minimized potential disruptions in laboratories.
  • 100% Baseline Success
  • Maintaining a perfect success rate across three integrated release cycles.

06

IMPLEMENTED SOLUTION

  1. Service Definition

    Service Definition

    A structured service catalog covering "Baseline release support", "Bug fixing", and "Emergency support".

  2. Commercial Agility

    Commercial Agility

    Implementation of a consumption-based reporting model for transparency in engineering effort utilization.

  3. Continuous Support

    Continuous Support

    Ongoing lifecycle management ensuring the longevity and reliability of modular biotech assets.

  4. Validation Rigor

    Validation Rigor

    Maintaining high quality through 3 integrated release cycles and rigorous FAT execution.

  • 3

    Integrated Release Cycles

  • 100%

    Baseline Success Rate

  • 100%

    IP Clarity (Retained ownership model)

Looking to secure your operational stability with Lifecycle Management services? Select your area of interest below, and let’s turn your maintenance hurdles into a competitive advantage.

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