OOS Investigation Tools: Streamlining Out-of-Specification Investigations Out-of-specification (OOS) events are critical occurrences in pharmaceutical manufacturing, representing deviations from established specifications and potentially impacting product quality and patient safety. Efficient and thorough investigations are crucial to identify root causes, prevent recurrence, and ensure product compliance. This post explores essential tools that streamline OOS investigations. Key Tools and Examples of OOS investigation Tools: 1. Electronic Data Capture (EDC) Systems: These systems are crucial for managing clinical trial data, but their principles of data integrity, audit trails, and secure storage are highly relevant to OOS investigations. Veeva Vault EDC: Veeva is a well-established name in the life sciences industry. Vault EDC is a cloud-based platform specifically designed for clinical data management. Its features like audit trails, electronic signatures, and version contro...
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