makeHistori

Empowering Biotech Manufacturing Through Intelligent Automation

At makeHistori, we specialise in delivering advanced Process Control and Manufacturing Execution System (MES) solutions tailored specifically for the life sciences industry — with a deep focus on biotechnology and regulated manufacturing environments.

With decades of combined experience, we bring a unique blend of domain expertise, platform knowledge, and innovative thinking to every engagement.

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Our Expertise

Process Control & MES Integration

We support end-to-end project delivery across process automation and MES landscapes. From initial user requirements through to validated functional specifications, we work in accordance with GAMP 5 and ISPE best practices, ensuring regulatory compliance and audit-readiness at every stage.

Our platform experience includes:

AWS-Enabled Digital Transformation

We help clients bridge the gap between traditional automation and cloud-native architecture by leveraging the AWS platform stack for:

Our approach empowers life science manufacturers to unlock insights, enhance visibility, and enable rapid iteration — all within validated, GxP-compliant environments.

Protocol & Connectivity Solutions

Our team has extensive experience in designing and implementing robust data flows across:

We develop tailored architectures that bridge brownfield systems with modern cloud or on-premises platforms, preserving your existing investments while enabling future flexibility.

Digital Strategy & Architecture

We understand the critical trade-offs between:

  • Traditional Purdue Model architectures (ISA-95/88)
  • Modern Unified Namespace (UNS) and IIoT-driven models
  • Our consultants help you assess, plan, and implement architectures that suit your compliance, scalability, and digital maturity needs — without compromising data integrity or operational reliability.

    Why Choose Us?

    ISPE Member

    We stay current with evolving industry standards and contribute to shaping best practices.

    GAMP-Compliant Documentation

    From URS to FAT/SAT and CSV, we provide structured and auditable deliverables.

    Biotech-Focused

    Our experience spans upstream and downstream processes, from fermentation to fill-finish.

    Technology-Agnostic

    We work across platforms and vendors, ensuring solutions are tailored to your operational reality — not constrained by product bias.

    Let’s Build the Future of Biotech Manufacturing

    We believe in combining industrial-grade engineering with modern digital tools to drive efficiency, traceability, and innovation in life sciences manufacturing.

    Whether you’re upgrading legacy systems, designing a new facility, or implementing a cloud-based MES architecture — we’re here to help.

    Contact us today to discuss how we can support your next project.

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