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    Certificate of Analysis & Certificate of Conformity

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    IBM® and AWS have collaborated to develop a cutting-edge solution that leverages the power of SAP and AWS services with Generative AI to create a Certificate of Analysis & Certificate of Conformity solution. The Solution automates pharmaceutical COA/COC validation by comparing certificates against manufacturer specifications and regulatory requirements across different product classifications. When discrepancies are found, it automatically generates supplier notification emails and places holds on ERP transactions until issues are resolved. The platform tracks supplier performance through a comprehensive analytics dashboard, generating compliance scores based on accuracy, deviation frequency, and response times. These metrics integrate into supplier scorecards, enabling quality teams to make data-driven decisions about vendor relationships while maintaining product quality standards throughout the supply chain.

    Overview

    The solutions work by first utilising the prompt engineering system to analyze Certificates of Analysis (COA) and Certificates of Conformity (COC) against predefined specifications, international export guidelines, and local regulations. Using natural language processing and pattern matching, it extracts key parameters from the submitted certificates and automatically cross-references them with the manufacturer's specification sheets stored in the ERP system. The system applies different validation rules based on product classifications like small molecules, biologics, controlled substances, and cold chain products, ensuring appropriate compliance checks for each category.

    For each parameter analyzed, the system performs statistical validation and flags any values that fall outside acceptable ranges or show suspicious patterns. When non-compliance is detected, it automatically generates a contextually appropriate email to the supplier detailing the specific issues found, including actual vs. expected values, relevant specification references, and requested corrective actions. Simultaneously, it places a systematic hold on the corresponding SAP ERP documents (Goods Receipt or Export Shipment Goods Issue) until the non-compliance is resolved, ensuring quality control at critical transaction points.

    The system maintains a continuous analytics engine that tracks supplier/exporter performance regarding COA/COC accuracy over time. It calculates compliance scores based on multiple factors including the frequency of deviations, severity of non-compliance, responsiveness to queries, and historical trends. These metrics are automatically integrated into supplier scorecards, providing objective data for vendor evaluation and risk assessment. The analytics dashboard enables quality teams to identify systemic issues and make data-driven decisions about supplier relationships.

    Highlights

    • - Automated generation of Certification of Analysis / Certificate of Conformity - Compare and check all parameters in the COA/COC are within the pharma manufacturers specification - Greater control over of Certification of Analysis / Certificate of Conformity process - Productivity boost due to automation and validation

    Details

    Delivery method

    Deployed on AWS
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