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We conduct a thorough CSV GAP assessment of the client’s existing validation framework, which encompasses the Validation Master Plan (VMP), Standard Operating Procedures (SOPs), IT infrastructure, and document templates. This evaluation identifies potential gaps or deficiencies in compliance with FDA, EMA, and GAMP5 regulations. Our primary goal is to ensure that the company’s CSV processes align with industry standards and regulatory requirements, effectively mitigating risks and enhancing the overall compliance posture within the organization.
Our team meticulously examines the client’s CSV background documentation, including SOPs and all relevant records, to evaluate their adequacy and alignment with regulatory guidelines. During this review, we identify discrepancies or gaps in the documentation, such as missing steps, outdated records, or inconsistencies in content. These findings form the basis of our CSV GAP assessment, helping clients understand their current compliance status and areas that require improvement.
We assess the client’s IT Infrastructure Qualification to determine its suitability for supporting CSV activities, with a focus on factors such as system architecture, data integrity measures, and cybersecurity protocols. This comprehensive assessment helps identify potential vulnerabilities or deficiencies within the IT infrastructure that could adversely impact the integrity and compliance of computerized systems. Addressing these gaps is crucial for maintaining robust CSV processes that meet regulatory expectations.
Our experts conduct a detailed review of the client’s document templates used for CSV activities, ensuring that they comply with regulatory requirements and industry best practices. We assess the comprehensiveness, accuracy, and consistency of key templates, such as User Requirement Specifications (URS), Risk Assessments, Traceability Matrices, and Validation Protocols. This thorough evaluation optimizes the effectiveness of these templates in supporting the CSV validation process and enhances overall compliance efforts.
Zamann Pharma Support offers customized digital solutions to streamline pharmaceutical operations. From AI-driven automation to robust platforms like eQMS and LIMS, we ensure seamless integration that enhances efficiency and compliance. Our expert team develops systems tailored to your specific business needs, ensuring optimal performance.
Zamann Pharma Support is a leader in delivering innovative digital solutions for the pharmaceutical industry. With extensive experience and specialized knowledge, we understand the unique challenges of digital transformation and regulatory compliance within a GMP framework. We support companies to turn paper based procedures to globally managed and fully digitized solution and have partnered with strong service providers for LMS, LIMS, QMS or Validation solutions.
