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    Computer System Validation (CSV)

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    • Computer System Validation (CSV)
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    • Deep Industry Expertise: Our experienced consultants have extensive knowledge of global regulations, including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
    • Comprehensive CSV Solutions: We offer a full spectrum of CSV services, from initial risk assessments and validation planning to execution, testing, and documentation.
    • Tailored Approach: We understand that every organization is unique. We customize our CSV services to align with your specific systems, processes, and regulatory requirements.
    • Focus on Efficiency: We streamline the validation process, minimizing downtime and maximizing efficiency while ensuring compliance.
    • GMP Services Providing in Ahmedabad & India: We are a leading GMP service provider, with a strong presence in Ahmedabad and across India.
    • QxP Pharma Consultants in Ahmedabad & Pharma Consultants in India: Local expertise with a national reach, we provide personalized service, and understand the regional regulatory nuances.

    • Our CSV Services Include:
    • Validation Planning & Strategy: Defining the scope, approach, and resources for your CSV project.
    • Risk Assessments: Identifying and mitigating potential risks to data integrity and system reliability.
    • Requirement Specification: Developing clear and concise user requirement specifications (URS).
    • Design & Configuration Validation: Ensuring that your systems are designed and configured to meet specified requirements.
    • Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ): Conducting rigorous testing to verify system functionality and performance.
    • Documentation & Reporting: Maintaining comprehensive and accurate validation documentation.
    • Periodic Reviews & Revalidation: Ensuring ongoing compliance and system integrity.
    • Remediation Services: Addressing validation gaps and resolving compliance issues.

    • Benefits of Partnering with QxP Pharma:
    • Reduced Regulatory Risk: Minimize the risk of regulatory citations and audits.
    • Improved Data Integrity: Ensure the accuracy, reliability, and security of your data.
    • Enhanced Operational Efficiency: Streamline your validation processes and reduce downtime.
    • Increased Confidence: Gain peace of mind knowing that your systems are compliant and validated.
    • Cost-Effective Solutions: Our experienced consultants provide efficient and cost-effective services.

    • Serving the Pharmaceutical Industry in Ahmedabad and Across India:

    • QxP Pharma, a top GMP services provider in Ahmedabad and India, helps pharmaceutical companies ensure regulatory compliance. Our consultants expertise in local and international regulations ensures your CSV projects meet the highest standards.

    • Let us help you navigate the complexities of CSV and ensure the compliance of your critical systems. Contact us today for a consultation and learn how we can support your organization’s success.