The Ultimate GMP Validated System Guide

From validation to streamlining and automating manufacturing processes, this guide is an indispensable tool for healthcare industry leaders.

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Your Ally in Building Custom
GMP Validated Systems

We’ll assign a technical leadership team, analyze your needs, identify the
required talent, and guide you through our comprehensive services-no
matter your project’s current stage.

Clients & compliance
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GMP Compliance Meets Digital Validation

In Pharma and Biotech manufacturing, outdated paper-based systems and manual reporting can hinder compliance and efficiency. We can support you to embrace precision automation to enhance compliance, improve product quality, and boost profitability.

GMP Solutions Illustration
GMP pattern
  • Robust platform building process
    that prioritises data, security & integrity

  • Comprehensive adherence to GMP standards, using a proven 3-step process to ensure success

  • AI automation removes human errors, bias, and allows for quicker processing, analysis & summary of tasks performed

  • Our expertise & mutual collaboration
    to overcome complex GxP platform-building issues

BGO Expertise in GMP Systems

15+ years of Expertise–ready to build solutions from scratch, seamlessly integrate IT teams or strategically consult.

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    Web–based GMP

    Real-time process support, GMP compliance with FDA regulations, and predictive analytics.

  • Verification (CPV) systems icon

    Continued Process
    Verification (CPV) systems

    Capture and centralised management of paper-based data.

  • Verification (CPV) systems icon

    Enterprise manufacturing

    Complex analysis in pharmaceutical

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Tailored Product & Process Solutions

BGO simplifies the complexities of Pharma and Biotech into streamlined solutions.

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    Automate reporting for auditing and regulatory compliance

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    Advanced data intelligence by integrating disparate systems

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    Enable real-time detection of suboptimal batches and enhance manufacturing processes

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    Boost efficiency and reduce drug manufacturing through ML, loT, AI, and big data analytics

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    Support Data Management, Advanced Analytics, Validated Reporting, and Data Visualization

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    Facilitate swift management of product monitoring metrics

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GMP Validation: Unleash Operational Excellence

Meet our GMP tech lead and learn how we can support build your GMP solutions

Contact Us Now
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Our Services

Digital Health Services for sustainable healthcare. Delivered with industry-leading NPS of 84%.

  • CTO as a Service

    Tailored Tech Consultancy

    Bring in a high-impact, senior technical leader specialized in your healthcare vertical. Let them handle your technology challenges, manage the engineering team, and guarantee the success of your projects.

    Learn More
  • Product Development

    Streamlined & Compliant

    Design and develop your digital health products using state-of-the-art agile methodologies, ensuring quick project start, reduced risks, and maximum success.

    Learn More
  • On-Demand IT Talent

    High–skilled & Flexible

    Custom–built digital health IT teams ready to integrate with yours, instantly expand capacity, and help implement your digital strategy roadmap–better, faster and more cost–efficient.

    Learn More

Do you still wonder what type of service
you need
for your project?

Book a discovery session with our team to ensure the success of your
project at an early stage

Why hire BGO Software’s Expertise
for GMP Validated Systems?

Mastering GxP platforms, we seamlessly integrate GMP standards into software, strategically and securely.

  • Optimal Software Design
    for Integration

    BGO prioritises intuitive, distraction-free
    design through a unified team approach,
    ensuring platform coherence.

  • Holistic Approach to
    Software Development

    End-to-end GMP software solutions,
    ensuring ease of use, data accessibility, and
    seamless platform operations.

  • Continuous Operations
    and Client Communication

    Seamlessly transitioning from planning to
    use, our GxP platforms align with evolving
    client needs and industry regulations.

  • Effective Internal and
    External Communication

    Balancing internal workflow with clear
    external communication, we ensure
    continuity and set clear goals with clients.

  • Controlled Testing

    Setting clear expectations when scoping
    and maintaining open communication,
    while we adeptly navigate new feature

  • Deep-Rooted Commitment
    to Core Principles

    Anchored in product quality, patient safety,
    and data integrity, BGO champions client
    success and ensures data precision.

  • Proven Expertise in Security Features

    Beyond just GMP, BGO has vast experience in web-based platforms dealing with sensitive personal data.

Featured GMP Case Studies

Data-driven Pharma Manufacturing Solution
Web platform

Data-driven Pharma Manufacturing

The solution is a powerful system that integrates various mathematical approaches to process data evaluation, enabling data-driven decision-making and accelerating future project implementation across the network.

  • company icon Top 5 Pharmaceutical Company
  • location icon Switzerland
  • date icon In progress
Microsoft .NET Angular Kendo UI +1
Explore Case Study
Drug Manufacturing Intelligence Solution
Web platform

Drug Manufacturing Intelligence

Manufacturing intelligence solution that automatically collects, analyses, and reports global manufacturing data. Real time process and product monitoring and continuous process verification.

  • company icon Top 5 Pharmaceutical Company
  • location icon Switzerland
  • date icon 3+ years
MySQL Kendo UI Microsoft .NET +2
Explore Case Study

The Ultimate GMP
Validated System Guide

From validation to streamlining and automating
manufacturing processes, this guide is an
indispensable tool for healthcare industry leaders

Download Free
The Ultimate GMP Validated System Guide

Maximise efficiency, ensure compliance,
and let simplicity take the lead.

Let’s Discuss Your Solution
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BGO Software utilizes dedicated teams and
structured communication, ensuring the
timely and seamless construction of our
web-based GMP platforms.
Harry Birimirski, GMP Solutions Architect • BGO Software See Articles
Harry Birimirski

We work with businesses worldwide, so get in touch!

Contact Us

Email us at or complete the form below,
and we’ll be in touch within 1 business day.

Discover how BGO can help with
GMP Compliance & Validation:

  • Maximize efficiency

    Maximize efficiency

  • Ensure compliance

    Ensure compliance

  • Automate data collection & reporting

    Automate data collection & reporting

  • Reduce manual work & errors

    Reduce manual work & errors

  • Enhance product quality

    Enhance product quality

  • Stay ahead of the curve

    Stay ahead of the curve


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BGO is trusted by top healthcare startups, Fortune 100 companies
and governments
for their digital health solutions.

  • Deep Healthcare Expertise

    We seamlessly integrate to accelerate your teams, delivering world-class solutions on time and within budget.

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  • Compliant Architecture

    We develop solutions that are fully secure
    and compliant
    with the globally established healthcare standards and requirements.

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    A Trusted Strategic Partner

    We go the extra mile to communicate and understand business objectives, leading to exceptionally high project success.

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GxP insights from our blog

Electronic Batch Record (EBR) Software In GMP
bgo logo 27 Jun 2024 - 12 min read

The Role of The Electronic Batch Record (EBR) Software In GMP

Healthcare technology

There isn’t a company in any kind of industry that deals with manufacturing and doesn’t know about Good Manufacturing Practices…

What Does the Newest Edition of GAMP®5 Bring to the Table?
bgo logo 13 Dec 2023 - 7 min read

What Does the Newest Edition of GAMP®5 Bring to the Table?

Healthcare technology

In the realm of digital health and life sciences, the transition from the first edition of GAMP®5 to the second…

Tech Stacks and Business Understanding
author img 15 Nov 2023 - 7 min read

Tech Stacks and Business Understanding: Key Success Factors in Building GMP Validated System

Healthcare technology

Creating GMP (Good Manufacturing Practice) validated systems stands as an achievement for any software development team. However, the sector that…


Why Work With Us


15 years of working on digital health products in regulated industries.


A wide variety of successful projects and industry expertise.


An innovation culture shaped by mutual trust, creativity, agility and adaptability.


We are honoured to have gained the trust of government and corporate leaders.

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Did you know that BGO Software is one of the only companies strictly specialising in digital health IT talent and tech leadership?

Our team has over 15 years of experience helping health startups, Fortune 100 enterprises, and governments deliver leading healthcare tech solutions.

If you want to explore your options, would you like to book a free consultation call today?


It’s a free, no-obligation, fact-finding opportunity. You’ll have a friendly chat with our team, ask any questions, and see how we could help in detail.