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At Aegis Analytical, we understand the need to balance good business practice with regulatory requirements. Aegis Discoverant® helps make regulatory compliance more achievable. This kind of efficiency goes straight to your bottom line.
Discoverant enables live, read-only access and conditioning of data from multiple sources and presents the information in the context most useful to each user. Discoverant creates a validated environment for easy, immediate access to all your process data, from raw materials to finished products. Discoverant is pre-certified to FDA validation standards with fully compliant construction. Original source data remains unaltered.
- Maintain process control and identify the root causes of atypical performance quickly and easily to ensure continuous compliance with FDA regulations. Discoverant makes it easier to identify the root causes of atypical performance especially when they involve interacting process parameters in several parts of the process. You can make corrective adjustments more quickly to bring the process back under control in a documented fashion that meets FDA requirements.
- Quickly disposition batches. Discoverant assembles data from all your manufacturing systems (raw materials, in-process and final product), and provides integrated analysis and reporting capabilities, assisting with your compliance requirements.
- Set and defend specifications that strike the right balance between business pragmatism and FDA regulations. Discoverant provides integrated process capability assessment that gives you the data and analysis you need early in the product life cycle to mitigate regulatory issues and minimize potentially negative impact on your business.
- Document process control and reverse adverse trends quickly to minimize process problems and failures. Discoverant lets you quickly and easily discern trends in the variability of critical process parameters and prevent problems before they occur.
- Streamline FDA reporting and assemble Annual Product Reviews (APRs) in hours instead of days or weeks. Discoverant provides live, interactive, read-only access to all manufacturing and quality data for faster, more efficient analysis and reporting.
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