In a GxP context, the disruption of traceability and the loss of environmental measures have potentially critical consequences for the business.
Depending on the field, this can be the scrapping of a manufacturing batch, a stored raw material or the refusal of a MA (Marketing Authorisation). This results in a medical risk and/or significant financial losses.
Scrupulously observed during internal and external audits, the loss of data will have an impact on quality monitoring (CAPA, deviation, etc.) – hence the importance of setting up a reliable infrastructure. It will therefore be necessary to ensure the redundancy of the system throughout the measurement chain as well as the setting up of “buffers” (temporary storage/buffer memory) at the different levels of acquisition.
The solution will ensure the principle of data integrity – i.e. setting up a system to verify and protect data against actions aimed at corrupting its integrity – from the sensor to long-term storage in the database.
The data history will be kept in accordance with current regulations (21 CFR Part 11 and Appendix 11). It must remain accessible to allow the edition of reports and trend curves.
Access to the environmental monitoring software will have to be facilitated in terms of means (standard workstation, remote access, smartphone), but it will have to be secure. Different user profiles will be defined with their own visibility and actions. All actions, especially those related to configuration changes, will be traced and accessible. The implementation of electronic signatures will make it possible to secure and authenticate access. It should be noted that the electronic signature will have the same legitimacy as a handwritten signature.
For more information please do not hesitate to contact us:
+33 (0)6 28 31 47 73
+33 (0)4 75 83 52 73