Audit trail gaps are among the top data integrity concerns during regulatory inspections. This article explores common pitfalls and how to avoid them with smart validation and QA practices.
Pharmaceutical firms must prioritize data integrity and robust procedures to meet FDA and EU regulatory expectations. Understanding their detailed guidelines is vital for compliance and data quality. Successfully navigating these regulations requires mastering FDA and EU requirements, including best practices for data management. Companies should dedicate resources to implementing data integrity principles from both FDA and EU guidance.
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.
The end of the Salesforce and Veeva partnership is a game-changer for pharmaceutical companies. With the September 2025 deadline approaching, learn how to avoid operational disruptions, ensure compliance, and stay ahead of the competition by transitioning effectively.
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.
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.
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.
Validation software is a game-changer for the pharmaceutical industry. This blog explores how it enhances compliance, efficiency, and product safety, ensuring top-notch quality and regulatory adherence.
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.
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.
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.
Enhance efficiency and compatibility by transitioning from CSV to CSA, ensuring seamless integration across platforms and systems for improved performance and streamlined operations.
Unlock the secrets of regulatory compliance comparison of EU Annex11 and 21CFR Part 11! These guidelines differ in scope and requirements, ensuring your computerized systems meet the highest standards in pharmaceutical and life sciences.
GAMP is the acronym used to summarize the term “Good Automated Manufacturing Practices“. These are a compilation of recommendations published by the International Society for Pharmaceutical Engineering (ISPE) in the form of a book to provide guidance on the compliance of computerized systems in regulated industries.
Computer Systems Validation (CSV) – is a process used to test, validate and formally document that a regulated computer-based system does exactly what it is designed to do in a consistent and accurate manner that is secure, reliable and traceable.
