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Building Fully Compliant
GMP Software

From discovery to deployment, we help pharma and biotech teams design,
staff, validate, and scale digital systems aligned with GAMP 5 guidance and
global GxP regulatory expectations

Clients & compliance
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Still Relying on Paper or Disconnected Systems?

Legacy tools slower batch releases and limited auit rediness. Manual documentation and fragmented data handoffs introduce compliance risk and gaps, that can lead to inspection findings. We help pharma and biotech manufacturers modernize their GMP workflows without compromising regulatory expectations or operational control.

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  • GMP-by-design architecture
    with embedded audit trails, role-based access,
    and data integrity

  • Validation-first delivery
    following GAMP 5 and CSV best practices

  • AI Smart automation
    to minimize manual entry and streamline
    QA data entry and reporting workflows

  • Collaborative model
    that integrates directly with your Quality,
    IT, and Validation teams

BGO Expertise in GMP Systems

15+ years of Expertise
We design, develop, and validate GxP-critical systems from the ground up. Or embed layering into your existing IT and QA infrastructure.

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    Web–based GMP
    platforms

    Real-time process support with secure data capture, audit trail GMP & FDA compliance, and predictive analytics.

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    Continued Process
    Verification (CPV) systems

    Centralized monitoring and statistical control to support FDA/EMA CPV expectations and ICH Q10 compliance.

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    Enterprise manufacturing
    intelligence

    Convert siloed data into insights for trend analysis, deviation tracking, and predictive quality improvements.

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Tailored Product & Process Solutions

BGO simplifies complex Pharma and Biotech operations into audit-ready, data-driven digital systems.

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    Automate reporting
    Streamline regulatory submissions and audit prep with validated, inspection-ready reports.

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    Advanced data intelligence
    Integrate siloed systems to improve decision-making and enable cross-functional visibility.

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    Real-Time Batch Monitoring
    Detect anomalies early and optimize processes to avoid batch failures or deviations.

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    Efficiency at Scale
    Accelerate drug manufacturing using AI, ML, and IoT technologies without compromising compliance.

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    Data Management & Visualization
    Ensure data integrity with validated pipelines, analytics, and traceability across the lifecycle.

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    Streamlined Metrics Oversight
    Track product quality KPIs and process performance with centralized dashboards.

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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
  • Healthcare Engineering Team

    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
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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 Choose BGO Software for
GMP-Validated Systems?

We specialize in building digital systems that align seamlessly with GxP expectations—enabling pharma and biotech teams to operate with confidence, speed, and compliance.

  • GxP-Centric Design for Integration

    Distraction-free, compliant interfaces that reduce user error and ensure audit-readiness across your platform landscape.

  • End-to-End GMP Software Delivery

    From URS to PQ, we deliver fully validated systems with traceability, usability, and compliance built in.

  • Validation-Aligned Collaboration

    We co-author goals with your QA/CSV teams to meet internal SOPs, V-model expectations, and global guidelines.

  • Reliable Handover & Lifecycle Support

    We support your team from system design through to steady-state operations—ensuring data integrity and change control are maintained.

  • Structured, Risk-Based Testing Environment

    Scalable testing strategies, aligned to criticality and risk, ensure compliance without overburdening internal resources.

  • Quality-Driven Culture

    Rooted in patient safety, data precision, and continuous improvement. Our approach reflects the core values of regulated manufacturing.

Featured GMP Case Studies

Data-driven Pharma Manufacturing Solution
Web platform

Data-driven Pharma Manufacturing
Solution

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
Solution

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
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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
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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

Start your project’s success here.
We’ll be in touch within one 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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How to contact you?

I’m looking for support with:*
  • Healthcare Technology Consulting
  • Software Product Development
  • Prototype Validation & Testing
  • Pharma Software & Systems Development
  • IT Expert Hiring
  • Clinical Research Systems Development
  • Other

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Controller of Your personal data is BGO Software OOD, UIC 200119953 (BGO);

The purpose of the processing is having Your contact data in order response to Your query;

Your personal data is processed on the grounds of BGO's legitimate interest;

Possible recipients of Your personal data are only persons who have legal grounds to process the data;

Your personal data shall be kept for the necessary duration of time to answer your inquiry and destroyed within two weeks of the communication marked verbally or in writing as final;

You have the following rights:

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  • Right of claim with the respective governing body;
  • Right of erasure;
  • Right of objection to the processing

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

Frequently Asked Questions

Our GMP manufacturing software ensures full GMP compliance by integrating quality management systems that comply with FDA regulations and GMP guidelines. We provide support for audit management, ensuring that companies rely on the software to meet regulatory compliance and quality assurance.

The system manages document control, electronic batch records, and work instructions to ensure compliance with quality standards and Good Manufacturing Practices (GMP). This helps manufacturers maintain full daily operations in line with the highest standards.

The software enhances manufacturing operations with key GMP software features like real-time monitoring, batch production records, and electronic device history records. It streamlines manufacturing processes and production processes, leading to improved operational efficiency and product quality.

Integrated AI and automation tools reduce human error and allow for quicker corrective and preventive actions (CAPA), improving overall quality control and reducing waste in raw materials usage.

In addition, our GMP software solutions provide specific quality processes to help meet the GMP guidelines required for compliance, ensuring good manufacturing practices (GMP) are always adhered to.

Our software integrates advanced risk management tools, allowing manufacturers to address risks throughout the manufacturing process. This includes features for change control, corrective and preventive actions (CAPA), and security measures to ensure data integrity.

The software focuses on continuous improvement by tracking and monitoring compliance audits and GMP audits, ensuring it consistently meets quality assurance requirements. It also integrates laboratory controls to ensure compliance with all necessary standards during testing and evaluation phases.

The software features a robust document management system with paperless documentation, version control, and electronic device history records. This ensures secure data storage and easy access for audit management. It supports compliance audits and guarantees that all documentation related to production processes, raw materials, and work instructions meets regulatory standards.

Our focus on quality and safety ensures that pharmaceutical products are consistently produced according to good manufacturing practices (GMP). Furthermore, the software includes GMP covers to help streamline daily operational procedures across manufacturing sites.

Our software is designed to be future proof by incorporating regular updates, security measures, and regular inspections to adapt to evolving regulatory standards and GMP guidelines.

The system facilitates production visibility and allows manufacturers to maintain consistent GMP compliance through features like document control, design control, and data integrity. This ensures long-term adherence to industry changes, enabling companies to comply with good manufacturing practices (GMP) for pharmaceutical products and human consumption.

In addition, our management software allows companies to maintain streamlined processes while providing access to real-time data for long-term strategic planning.

By integrating GMP software solutions, manufacturers can future-proof their operations and ensure that their company remains compliant with industry standards and has the tools to continuously improve processes and products.

  • 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.

    • 70 Clients
    • 120 Projects
    • 84 NPS info icon

GxP insights from our blog

Harry Birimirski - Senior Solution Architect
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…

Female doctor discussing something with patients.
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…

Scientist in protective clothing with mask and goggles holding a tablet.
bgo logo 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…

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Why Work With Us

Experience

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

Knowledge

A wide variety of successful projects and industry expertise.

Culture

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

Trust

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

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Hello!

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?

Yes

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.