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AmplifyBio: Championing Digital Transformation in Advanced Therapy with ValGenesis and Beyond

For AmplifyBio, adopting a robust digital strategy across our functions goes beyond mere convenience; it’s a strategic imperative. It enables us to provide the efficiencies, protection, and real-time data analysis essential for meeting our clients’ needs. Embracing this digital transformation offers myriad benefits, extending far beyond mere cost savings. Enhanced data integrity, regulatory compliance, and our ability to be at the forefront of digital strategies are integral to our vision of becoming the premier development partner for advanced therapy, guiding projects from concept to commercial success.

Recently, we successfully launched the ValGenesis Validation Lifecycle Management System (VLMS) to streamline our digital validation processes. Adopting ValGenesis VLMS was a strategic choice consistent with our commitment to a digital-first approach. We commenced the implementation of the system in late 2023 with the goal of overhauling our computer systems validation program. Remarkably, the implementation process was completed within just eight weeks. (Read the Valgenesis case study here.)

Beyond merely adopting a purpose-built validation system, we seized the opportunity to revamp our existing Computer Systems Validation (CSV) process, steering away from automating what had become less than optimal. The immediate impact of these changes has been significant, with several process improvements noted. These enhancements include a 50% reduction in the steps and time required for document approval, the consolidation of objective evidence in a single step (eliminating the need for tedious copy/pasting), a 50% decrease in audit findings by eradicating documentation errors, improved collaboration with remote colleagues, the standardization of protocols, and a reduction in subjectivity when assessing risk.

The adoption of Valgenesis represents the most recent initiative in an aggressive strategy aimed at positioning AmplifyBio as the primary digital partner with a focus on data-first solutions, meeting the essential requirements of our clients. In the preceding 18 months, we have implemented:

  1. Electronic Document Management System (EDMS) and Quality Management System (eQMS)
    A leading EDMS (Electronic Document Management System) and eQMS (Quality Management System) were chosen as the foundation for a successful digital transformation, streamlining document control, collaboration, and quality processes for improved transparency, compliance, and accessibility.

  2. An automated Asset Calibration and Maintenance System
    Our automated asset calibration and maintenance system ensures accurate and reliable equipment, minimizing error risk and enhancing data integrity, which is vital for pharmaceutical development.

  3. Intelligent Sensing and Environmental Monitoring (EMS)
    Our intelligent Environmental Monitoring System (EMS), equipped with smart sensors, provides real-time lab insights, proactively safeguards experiments, and guarantees data integrity through continuous environmental monitoring.

  4. Modern LIMS and Electronic Lab Notebooks
    Laboratory Information Management Systems (LIMS) and Electronic Lab Notebooks (ELN) are indispensable tools for our researchers and offer a modern and integrated platform, allowing seamless data capture, collaboration, and compliance. This digital solution not only enhances data traceability but also accelerates the pace of research by providing researchers with powerful tools for experimental design and analysis.

  5. Informatics Data Pipelines and Lab Automation
    Integrating informatics data pipelines and lab automation accelerates our research workflow. Automating complex analyses allows us to generate reports in weeks, instead of months or multiple studies, significantly reducing costs and turnaround time. This grants researchers faster, more efficient data access and expedites timelines while minimizing manual error risks.

  6. Manufacturing Execution System (MES/eBPR)
    As we have expanded into manufacturing services, onboarding an innovative Manufacturing Execution System (MES/eBPR) is pivotal in connecting research and development with manufacturing activities. This seamless integration enhances visibility, control, and traceability across the entire production process, ensuring a smooth transition from lab-scale development to large-scale manufacturing.

  7. Supply Chain Inventory Management
    Our supply chain inventory management solution optimizes the logistics of pharmaceutical development. It mitigates the risk of supply chain disruptions by providing real-time visibility into inventory levels, order statuses, and supplier relationships. This ensures a steady flow of materials for development, preventing delays and minimizing project timeline impact.

  8. Data Analytics and Business Intelligence Dashboards
    Data-driven insights are crucial for success in today’s pharmaceutical industry. Business analytics dashboards translate data into actionable insights for stakeholders, enabling informed decision-making, process optimization, and innovation.

Read More:

Manufacturing at AmplifyBio

Manufacturing at AMEC

AmplifyBio BioAnalytic Services

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