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In Pharma and Biotech manufacturing, outdated paper-based systems and manual reporting can hinder compliance and efficiency.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.
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Robust platform building process
that prioritises data, security & integrity -
Comprehensive adherence to GMP standards, using a proven 3-step process to ensure success
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AI automation removes human errors, bias, and allows for quicker processing, analysis & summary of tasks performed
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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
platformsReal-time process support, GMP compliance with FDA regulations, and predictive analytics.
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Continued Process
Verification (CPV) systemsCapture and centralised management of paper-based data.
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Enterprise manufacturing
intelligenceComplex analysis in pharmaceutical
production.
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
GMP Validation: Unleash Operational Excellence
Meet our GMP tech lead and learn how we can support build your GMP solutions
Our Services
Digital Health Services for sustainable healthcare. Delivered with industry-leading NPS of 84%.
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CTO as a Service
Tailored Tech ConsultancyBring 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.
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Product Development
Streamlined & CompliantDesign and develop your digital health products using state-of-the-art agile methodologies, ensuring quick project start, reduced risks, and maximum success.
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On-Demand IT Talent
High–skilled & FlexibleCustom–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.
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Optimal Software Design
for IntegrationBGO prioritises intuitive, distraction-free
design through a unified team approach,
ensuring platform coherence. -
Holistic Approach to
Software DevelopmentEnd-to-end GMP software solutions,
ensuring ease of use, data accessibility, and
seamless platform operations. -
Continuous Operations
and Client CommunicationSeamlessly transitioning from planning to
use, our GxP platforms align with evolving
client needs and industry regulations. -
Effective Internal and
External CommunicationBalancing internal workflow with clear
external communication, we ensure
continuity and set clear goals with clients. -
Controlled Testing
EnvironmentSetting clear expectations when scoping
and maintaining open communication,
while we adeptly navigate new feature
challenges. -
Deep-Rooted Commitment
to Core PrinciplesAnchored in product quality, patient safety,
and data integrity, BGO champions client
success and ensures data precision.
Featured GMP Case Studies
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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.
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Top 5 Pharmaceutical Company
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Switzerland
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In progress
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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.
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Top 5 Pharmaceutical Company
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Switzerland
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3+ years
Maximise efficiency, ensure compliance,
and let simplicity take the lead.
Let’s Discuss Your Solution
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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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:
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Maximize efficiency
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Ensure compliance
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Automate data collection & reporting
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Reduce manual work & errors
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Enhance product quality
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Stay ahead of the curve
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.
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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. -
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
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84
NPS
BGO is the highest-rated healthcare IT services provider for a reason
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.
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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.