Regulatory Compliance through Scientific Data Management Systems

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Webinar Summary
Many of us feel confident that instrument data from the laboratory is protected in each instrument system (CDS, UV, IR, Mass Spec., etc.) and is successfully transferred into a LIMS either manually or via a system linkage. Many of us feel that is enough control of the raw data, and that no further action is necessary. However, in the current compliance environment, this necessarily may not be true.

Key regulatory requirement and expectations are
1. Effective instrument integration in real-time from all types of instruments and all types of file and data formats.
2. Secure storage of the raw data and processed data at the time they are produced,
3. Secure storage and archival of the data for both internal and external audit purposes
SDMS- Scientific data management system is the potential solution beyond LIMS, ELN, CDS, and Manual data storage and archival.
In this webinar, Sai Life Science is presenting the industry first such solution deployed successfully and their benefits in handling instrument integration, data storage and archival functions and heading towards the fully paperless lab.

About Dr. M. Damodharan
Dr. M. Damodharan is currently associated with Sai Life Sciences Limited since 2014, prior to which for almost a decade he was associated with Ranbaxy Laboratories Ltd., as Head-API Global Quality. His professional journey includes assignments with GSK, Jubilant Generics, and Shasun Pharmaceuticals Ltd. Under his leadership, Sai has received the most prestigious “Golden Peacock National Quality Awards - 2020” for the world-class Quality systems and practices.
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Management
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