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Drug Manufacturing QMS
for Pharma Industry

Ensure quality and compliance throughout the Pharmaceutical demand chain

QMS software screen

We Are Innovating
The Drug Manufacturing

The interplay between quality and safety is of significant importance in the pharmaceutical industry. As ofteuality and monitoring closely the production is vital. BGO Software develops GMP, FDA and EMA compliant software solutions to ensure the quality of the process, process verification and product monitoring in the Pharmaceutical Industry. We build custom purpose-built GxP solutions fn lives rely directly on the products developed by pharma organisation, tracking qor quick and centralised global access to real-time process and product monitoring.

Integrate Data from Key
Technologies into a Purpose-built
GMP System for Real-time Process
and Product Monitoring

  • Data Management

  • Advanced Analytics

  • Validated Reporting

  • Data Visualization


Use Data Intelligence to Improve
Quality Management

BGO Software builds integrated software solutions that collect intelligence across the whole drug manufacturing process and ensure end-to-end quality, consistency and GMP compliance. Our drug manufacturing quality monitoring solutions store information, perform KPI calculations, perform data analysis and identify correlations between CPPs and KPIs. Thanks to the comprehensive software capabilities, you can perform a site process and product monitoring, infra- and inter-batch assessment, root-cause assessment, establish control limits, and many more.

  • Centralized global access

    to process and product monitoring data

  • Generate Process

    and Product Monitoring reports

  • Evaluation of intra-batch

    and inter-batch variation in a process

  • Early warning

    of out-of-trend conditions

  • Understand the impact

    of variations

  • Data storing

    in a validated secure format

  • Investigate deviations

    and troubleshoot process issues

  • Reduce man-hours

    spent reconciling data from various sources

  • Identify opportunities

    for process improvement

  • Support batch genealogy

    to track the quality of incoming materials

Key Benefits

  • Leverage Data Intelligence

    Monitor unified data in a single source of truth. Generate custom reports to optimise even more the drug manufacturing process.

  • Guaranteed Quality

    The quality of the production process and drugs is paramount for the Pharma industry. Ensure patient safety by in-depth monitoring.

  • Eliminate Risks

    Avoid the chase to produce unmarketable batches like malformed or contaminated products. Handle discrepancies immediately.

  • Ensure Compliance

    BGO Software’s GMP compliant solutions are developed according to all necessary standards and help you stay compliant.

Trusted by Global Clinical Research Entities

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