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NanoRam update readies instrument for new FDA data integrity guidance

The NanoRam is a handheld instrument used for non-destructive identification and verification of materials such as active pharmaceutical ingredients (APIs), excipients and intermediates. These software updates provide improvements on data integrity, security and activity tracking through the Audit Trail to make user experience with the NanoRam safe and secure. These updates are being released in compliance with the future publication of the Data Integrity and Compliance with CGMP Guidance for Industry, the purpose of which is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211 and 212. The guidance provides the FDA’s current thinking on the creation and handling of data in accordance with CGMP requirements, and the NanoRam software updates ensure these guidelines are followed.

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