CONSISTENT

The second concept that has been recently added to the ALCOA+ principle is Data Consistency.

All data should be chronologically arranged, with time stamps included for any addition to the original data. Consistency should be ensured by applying various audits over the data’s lifecycle.

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

Warning Letter 320-19-37 (August 2019)

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

The computer systems you use to control the operations of your analytical instrumentation do not have audit trail capabilities, including Gas Chromatography (GC) instruments used for drug product stability analyses and Fourier Transform Infrared Spectroscopy (FTIR) and Ultraviolet (UV) spectroscopy instruments used for raw material release testing.

In response to this letter, provide:

  • A comprehensive independent review of your entire data system and investigation into the inadequacies in data, records, and reporting. Describe all parts of your facility’s operations in which CGMP information is not recorded and maintained.
  • Your detailed CAPA plan to remediate data recording and record retention practices throughout your operation. Your CAPA plan should include, but not be limited to, appropriate controls to maintain and prevent the deletion and alteration of raw data files.
  • Provide a risk assessment summarizing the effect of incomplete data on assessing laboratory results and product quality.

The consistency of data in a quality control laboratory is critical to demonstrate that all activities have been carried out in a logical and chronological order. This implies that all performed activities have been so without the generation or use of unjustified data, without the possibility of modifying dates and times of the computer systems or annotations in registration books, and writing down all the results obtained, documenting, if necessary, repetitions of the same test.

For this reason, during the process of environmental monitoring of an area, it is crucial to verify that all the data entered into the system, from the initial phase of sampling to the incubation and final reading, remain unchanged in the system. The Audit Trail functionality allows the user to see if there has been any modification to the introduced data, along with the person who made it and its justification.

In addition, a system that generates reports automatically, must document the person who generate it and date when they did it. The report should also contain the premises or limitations in the data set used for it and the individual and group pagination of the report to ensure that no information is lost.

As we have mentioned in previous articles, the SherpaPharma system’s Audit Trail allows to trace all the events in the system and document their approval according to the Audit Trail revision policy established by the company. Also, as seen in the following image, all the reports include the date range, the filtering criteria, the pagination, and it has the date and user who generate it. By doing so, all the basic data of the report’s preparation is fully documented.