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Category: Computerized System Validation

As a SaaS platform, Veeva regularly updates its features and capabilities without requiring downtime or costly upgrades.
Computerized System Validation

Use the Full Potential of Veeva: A Introduction for Pharma and Biotech Companies

Uncover the numerous advantages that Veeva offers specifically for the pharmaceutical and biotechnology sectors by reading this insightful whitepaper. Delve into the ways in which its software-as-a-service (SaaS) solutions enhance operational efficiency and significantly enhance regulatory compliance within these industries. This comprehensive examination will provide valuable insights into the transformative impact of Veeva’s technology on business processes and adherence to industry standards.

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December 11, 2024
Effective cybersecurity in CSV starts with a comprehensive risk assessment.
Computerized System Validation

Cybersecurity in CSV: Integrating Best Practices

As cyber threats evolve, incorporating cybersecurity in CSV processes is essential. Discover the importance of protecting sensitive data and how to implement effective cybersecurity measures in validation frameworks.

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December 2, 2024
Computerized System Validation

Agile Meets GAMP 5: Streamlining CSV

Explore the integration of Agile methodology into Computer System Validation (CSV) guided by GAMP 5 principles. This approach offers enhanced flexibility, faster validation, and improved compliance, ensuring your software systems meet regulatory standards efficiently.

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July 31, 2024
Computerized System Validation

Data Integrity: Key requirements for Computerized Systems

Data integrity ensures that data generated throughout the manufacturing process is accurate, reliable, and secure. Data integrity refers to the completeness, consistency, and accuracy of data throughout its lifecycle, from creation and processing to storage and retrieval.

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July 3, 2024
Periodic Review of Computerized system
Computerized System Validation

Essential Steps for Conducting Effective Periodic Reviews in CSV

Periodic reviews are conducted throughout the operational life of computerized system to verify that it remains in a validated state, complies with current regulatory requirements, is fit for intended use, and satisfies company policies and procedures. The review should confirm that operational controls are in place and are being effectively applied.

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June 3, 2024
Computerized System Validation

7 Steps to Conduct GAP Assessment for Computerized Systems

In Computer System Validation, GAP assessment serves to pinpoint differences between a company’s existing procedures, practices, and policies and relevant regulatory guidelines and compliance standards. It involves gathering evidence to delineate the variance between requirements and current strengths.

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May 27, 2024
Protection of sensitive data
Computerized System Validation

Enhancing Security through Periodic User Access Reviews

Periodic user access reviews are essential for maintaining the security and integrity of computer systems in the pharmaceutical industry. They play a crucial role in safeguarding sensitive data and ensuring compliance. This blog explores the importance, challenges, and strategies for implementing effective access controls.

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May 15, 2024
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