Enduring

The third concept recently added to the ALCOA+ principle is Data Endurance.

While this concept is also touched on the previous principle (Consistency), in this case a special emphasis is made on making sure that data is available long after it is recorded (even decades in some situations).

Materials or systems used to record data must be persistent long enough without losing readability. For example, product quality data should be kept and be readable at least for one year after the expiration of manufactured products. On the other hand, facilities’ qualification documents should be kept and be readable as long as the installation is in use.

To illustrate the Endurance concept let’s look at an example with one FDA warning letter:

FDA Warning Letter 320-18-46 (April 2018)

 Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)).

Your firm was unable to provide complete raw data related to the qualification of your “(b)(4)” water system. You lacked basic information (including missing sanitization data) to assess water system performance. According to your employee, half the data you generated over a year was lost.

Your laboratory also lacked data such as weight of samples, test methods, records of calculations performed, standards used for release of final products, and water monitoring data.

 Our inspection also indicated that your water system is not suitable for its intended use. Specifically, our findings indicate that your water system was not appropriately designed, controlled, and maintained to consistently produce high-purity water.

In response to this letter, FDA requests the following:

• A comprehensive assessment of the documentation systems used throughout your manufacturing and laboratory operations to determine where else you lack complete records. Include a detailed CAPA plan with systemic remediations to assure your facility maintains complete records. The CAPA should include, but not be limited to, revised procedures, training, and systemic actions implemented to assure integrity of all CGMP records.

SherpaPharma ensures the Endurance of data.

After a process has been performed (for example, sampling) the related data is blocked. It cannot be modified or deleted. Complementary information can be added to the process data and any modification will be tracked in the Audit Trail.

SherpaPharma is running in the cloud on high availability servers. Daily backups are performed and copied to different geographical locations for additional security. Our SOP for disaster recovery is validated periodically to ensure data is persistently safe and accessible even in case of a disaster. Our clients are welcome to audit the data centre as well as SherpaPharma procedures.

Figure 1. SherpaPharma screen showing blocked fields of sample data after a sample has been performed.