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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In Pharma and Biotech manufacturing, outdated paper-based systems and manual reporting can hinder compliance and efficiency.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.
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
15+ years of Expertise–ready to build solutions from scratch, seamlessly integrate IT teams or strategically consult.
Real-time process support, GMP compliance with FDA regulations, and predictive analytics.
Capture and centralised management of paper-based data.
Complex analysis in pharmaceutical
production.
BGO simplifies the complexities of Pharma and Biotech into streamlined solutions.
Automate reporting for auditing and regulatory compliance
Advanced data intelligence by integrating disparate systems
Enable real-time detection of suboptimal batches and enhance manufacturing processes
Boost efficiency and reduce drug manufacturing through ML, loT, AI, and big data analytics
Support Data Management, Advanced Analytics, Validated Reporting, and Data Visualization
Facilitate swift management of product monitoring metrics
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Mastering GxP platforms, we seamlessly integrate GMP standards into software, strategically and securely.
BGO prioritises intuitive, distraction-free
design through a unified team approach,
ensuring platform coherence.
End-to-end GMP software solutions,
ensuring ease of use, data accessibility, and
seamless platform operations.
Seamlessly transitioning from planning to
use, our GxP platforms align with evolving
client needs and industry regulations.
Balancing internal workflow with clear
external communication, we ensure
continuity and set clear goals with clients.
Setting clear expectations when scoping
and maintaining open communication,
while we adeptly navigate new feature
challenges.
Anchored in product quality, patient safety,
and data integrity, BGO champions client
success and ensures data precision.
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.
Manufacturing intelligence solution that automatically collects, analyses, and reports global manufacturing data. Real time process and product monitoring and continuous process verification.
BGO Software utilizes dedicated teams andHarry Birimirski, GMP Solutions Architect • BGO Software See Articles
structured communication, ensuring the
timely and seamless construction of our
web-based GMP platforms.
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Reduce manual work & errors
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BGO is trusted by top healthcare startups, Fortune 100 companies
and governments for their
digital health solutions.
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.
We seamlessly integrate to accelerate your teams, delivering world-class solutions on time and within budget.
We develop solutions that are fully secure
and compliant with the globally established healthcare standards and requirements.
We go the extra mile to communicate and understand business objectives, leading to exceptionally high project success.
All vendors claim they can do the job, so that they get it. BGO actually delivers successful projects, and NPS score is the ultimate proof of that.
There isn’t a company in any kind of industry that deals with manufacturing and doesn’t know about Good Manufacturing Practices…
In the realm of digital health and life sciences, the transition from the first edition of GAMP®5 to the second…
Creating GMP (Good Manufacturing Practice) validated systems stands as an achievement for any software development team. However, the sector that…
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.
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