Published on March 26, 2018

Achieving zero loss of GxP data - what needs to be done

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In a GxP context, the breakdown of traceability and the loss of environmental measures potentially lead to critical consequences for the activity.

Depending on the activity, this may be the scrapping of a production batch, a stored raw material, the refusal of a marketing authorization, etc. The consequence is a medical risk and/or significant financial losses.

Carefully observed during internal and external audits, the loss of data will have an impact on quality monitoring (CAPA, deviation, etc.). Hence the interest of setting up a reliable system architecture. In this case, it will be necessary to ensure the redundancy of the system throughout the measurement chain. And the implementation of "buffer" (temporary storage) at different levels of acquisition.

The solution will have to take care of data integrity principles. That means, put in place a system of verification and protection of data against actions to corrupt their integrity. And this from the sensor to long-term storage in the database.

The historical data will be stored in accordance with the regulations in force (21 CFR Part 11). This one must remain accessible to allow the edition of report and trend curves.

Access to the environmental monitoring software should be facilitated in terms of means (ordinary post, remote access, smartphone), but it must be secure. Different user profiles will be defined with specific views and actions. All actions, including those related to configuration changes, will be trailed and accessible. The implementation of electronic signatures will authenticate and secure access. Note that the electronic signature will have the same legitimacy as a handwritten signature.