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
homepage hero

Building Fully Compliant
GMP Software

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
  • iqvia logo
  • roche logo
  • britannia logo
  • iso certifications logo
  • fda logo
  • gmp logo

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In Pharma and Biotech manufacturing, outdated paper-based systems and manual reporting can hinder compliance and efficiency.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.

  • GMP pattern Web–based GMP icon

    Web–based GMP
    platforms

    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
    intelligence

    Complex analysis in pharmaceutical
    production.

bgo signature logo

Tailored Product & Process Solutions

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

  • product-solutions icon 01

    Automate reporting for auditing and regulatory compliance

  • product-solutions icon 02

    Advanced data intelligence by integrating disparate systems

  • product-solutions icon 03

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

  • product-solutions icon 04

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

  • product-solutions icon 05

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

  • product-solutions icon 06

    Facilitate swift management of product monitoring metrics

cta box mask

GMP Validation: Unleash Operational Excellence

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

Contact Us Now
BGO Software signature

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
pattern

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
    Environment

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

  • 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
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
mask

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
pattern

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

Let’s Discuss Your Solution
quote icon
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

pattern

How would you like us to contact you?

  • Email

  • Phone

  • WhatsApp

I agree to BGO Software’s Privacy Policy

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:

  • access icon Right of access;
  • restriction icon Right to restriction of processing;
  • edit icon Right to rectification;
  • claim icon Right of claim with the respective governing body;
  • erasure icon Right of erasure;
  • objection icon 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.

    ISO Certifications HL7 logo Databricks logo
  • Compliant Architecture

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

    Hipaa logo GMP logo FDA logo GDPR logo PCI logo
  • blend orange

    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

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
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…

lines

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.

chat user icon

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.