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White Papers

You can find whitepapers published by Agaram.

techno functional consultant

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How Logilab SDMS helps Laboratories to enable 21 CFR Part 11 Compliance – Part 1

Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). In Part 1, the fundamental concepts of 21 CFR Part 11 and its vital requirements as applicable to Computerized systems in food and drug laboratories and manufacturing are discussed

SDMS Software
SDMS Software

How Logilab SDMS helps Laboratories to enable 21 CFR Part 11 Compliance – Part 2

In Part 2, overview of Logilab SDMS and its importance in 21 CFR Part 11 as applicable to Computerized systems will be described. Agaram Technologies’ Logilab SDMS is a generic software application designed to handle scientific instrument data from any analytical instrument and can facilitate data management with access control. 

How Logilab SDMS helps Laboratories to enable 21 CFR Part 11 Compliance – Part 3

In Part 3, how Logilab SDMS helps organizations to fulfil 21 CFR Part 11 requirements. Logilab SDMS is a closed system.  Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.

SDMS Software
SDMS Software