Building Fully Compliant GMP Software

We Support You

Product Quality Experts

Supporting quality with:
- Automated Annual PQRs
- Faster Batch Releases
- FDA Audit Readiness
- Product Quality Assurance
- Streamlined CAPAs
- Rapid Deviation Resolutions
Production
Experts

Improving production with:
- Client Process Visibility
- Optimized Batch Efficiency
- Downtime Risk Mitigation
- Resource & Asset Utilization
- Manufacturing Cost Efficiency
- Operator Process Compliance
TechOps
Experts

Supporting tech
operations to:
- Optimize Maintenance
- Avoid Unneeded Downtime
- Accelerate & De-Risk Tech Transfers
- Enhance Right-First-Time Execution
- Improve Root Cause Detection
Production
Experts

Improving production with:
- Client Process Visibility
- Optimized Batch Efficiency
- Downtime Risk Mitigation
- Resource & Asset Utilization
- Manufacturing Cost Efficiency
- Operator Process Compliance

Enterprise Data Ontology
system

Custom modules layered over your existing systems without requiring data migration or revalidation of the existing IT setup.

Record

Capture paper data and loT sensors digitally at the source.
Connect

Unify every system, one batch record. A batch's full history in a single query.
Release

Review only what needs attention. Clean batches move straight through hours off every release.
Foresee

Predict deviations. Drift corrected in-flight. Yield known before the batch closes.

Assure

Agentic digital validation of requirements, testing, changes, deviations and periodic review in one audit-ready flow aligned with your QMS and compliant with 21 CFR Part 11, Annex 11 and GAMP 5.

Operational Speed

First Results in Weeks, Thought
Specliazed Agentic AI Workflows

01 Gather Context

Understanding business goals. Problem deffiniton (legacy, disconnected systems, manual paper work, or non validated solution)

02 Define Solution

Focusing on key needs and prioritizations. Visualizing and prototyping.

03 Validated by Design

We fast-track it through agentic AI validation workflows following CSV and GAMP 5 best practices. Embedded audit trails, role-based access and data integrity.

04 Implement

Еvery batch strengthens the model. Compliance remains intact. Performance tightens over time.

Not sure where to start?

We will help you map your systems landscape and define your digital priorities in a free 2 hours discovery session.

Talk to an experts

Relevant Experience

Drug Manufacturing
Intelligence Solution

CHF 6.5 M annual savings
77.7 % reduction in reporting effort
101 hours of manual work eliminated

Data-driven
Pharma Manufacturing Solution

200 % Increased efficiency via automated systems

BGO Software utilizes dedicated teams and structured communication, ensuring the timely and seamless construction of our web-based GMP platforms.

Niyazi Karabayır, Digital Product Owner at Roche

Delivery Methods

End-to-end capabilities to solve complex challenges in regulated environments. With an industry leading Net Promoter Score of 84.

Consulting

End-to-end strategic, regulatory, AI and product consulting that helps organizations turn ideas into compliant, scalable
solutions.

Technology Development

Developing custom solutions. Whether you need to connect your systems, unify your data, migrate from legacy systems, or you have a unique idea, we can build it for you.

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Life sciеnces IT Extension

IT experts ready to integrate with your team, instantly expand capacity, and help implement your digital strategy roadmap-better, faster and more cost-efficient.

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