In a GMP-regulated cryobank, it is not enough for the samples to be stored at the correct temperature. It must also be possible to prove beyond doubt that they have been stored at the correct temperature. This proof requires data whose integrity and authenticity are beyond any doubt.
Data integrity requirements in the pharmaceutical and biomedical industries are defined by the ALCOA principles - an acronym that has now achieved the status of a regulatory standard. In this article, we explain what ALCOA means, how the principles apply to cryogenics and why they are far more than a bureaucratic exercise.
It must be possible to assign each data record to an identifiable person. Who read the temperature? Who opened the tank? Who started the freeze log? In practice, this means: individual user accounts, password-protected access to systems and automatic logging of the user ID for every action.
Data must be permanently legible and error-free. Handwritten entries in logbooks that fade or become illegible after years do not meet this criterion. Digital records in standardized formats (PDF/A, CSV) with redundant storage are the gold standard.
Data must be recorded at the time of the event - not hours or days later from memory. Automatic data acquisition systems, such as the Biosafe monitoring system from Consarctic®, fulfill this principle by design: temperature data is recorded in real time and without human intervention.
The original data record must be retained. Copies are permitted, but the original value must not be changed or deleted. In digital systems, this is ensured by write-once attributes or versioned data records with an audit trail.
The data must correctly reflect reality. For temperature data, this means calibrated sensors with documented traceability to national standards. For process data, it means validated software without systematic errors.
The original ALCOA principles have since been expanded to include four additional attributes known as ALCOA+:
Wherever possible, data should be recorded automatically. The Biosafe system from Consarctic® records temperatures and fill levels automatically and continuously - without human interaction and therefore without any human source of error.
The BIOFREEZE® software automatically creates an electronic batch record for each freezing process, which documents all relevant parameters. This record is linked to the user ID, the time stamp and the program used.
Internal data integrity audits should be carried out at least once a year. This involves randomly checking whether the recorded data meets the ALCOA criteria and whether the system is protected against manipulation.
Breaches of data integrity can have serious consequences:
Data integrity is not a burden - it is the foundation on which trust in your cryobank rests. Consarctic® systems and products are designed from the ground up to comply with ALCOA principles.
Do you need support with the implementation of ALCOA-compliant processes? Our consultants will help you with gap analysis and the optimization of your data systems.