Case Studies
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SQA Solution's Approach to 21 CFR Part 11 Compliance in a Global Healthcare Corporation

A global healthcare corporation faced significant challenges in complying with 21 CFR Part 11, especially section 11.10

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    Strategic SOP Development for Enhanced Infrastructure and Compliance for BioPharma

    Developing comprehensive SOPs in a biopharmaceutical context is fundamental for ensuring regulatory compliance, and maintaining high standards of quality and safety …

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      Comprehensive API Testing for a Leading Credit Manager in Commercial Real Estate Lending

      Before engaging our services, the client faced significant challenges in ensuring the reliability, security, and overall quality of their API functionalities …

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        SAP S/4 HANA GxP Compliance and Validation Project

        The objective is to align the SAP S/4 HANA system of a leading biopharma
        company with the stringent requirements of GxP regulations and
        21 CFR Part 11 …

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          SQA Solution Quality Systems and Compliance Consultant at a Biotechnology Company

          The consultant’s role is pivotal in ensuring the compliance of computerized systems with regulatory standards and internal policies.

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            Optimizing Software Quality and Performance for a Leading Multi-Channel Retailer

            The retailer required a robust software infrastructure to ensure seamless online shopping experiences and operational efficiency …

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