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ALCOA+ second concept: Data Legibility

Following the last ALCOA+ based publication, it is time to review its second concept: Data Legibility.

All pharmaceutical documents and data should be legible, that is it should be readable and permanent. They must be easily and accessed throughout the entire data lifecycle. This will help in easy retrieval of previous data in the pharmaceutical industries if needed.

This concept should not come as a surprise since it was already included in the beginning in the Good Documentation Practices.

To further illustrate the Legibility concept let’s look at an FDA warning letter:

Warning Letter 320-19-12 (February 2019)

Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).

Your batch production and control records do not include complete information.

Our inspector reviewed several batch records and found use of white-out correction liquid, unintelligible data, and/or missing information such as density test results and the date of approval of the batch. Several entries were over written and crossed out with no signature, date, or explanation.

In addition, laboratory test results (e.g., viscosity, density, appearance, and odor) lacked initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards.

One of the solutions that the FDA provides is:

“A comprehensive investigation into the extent of the inaccuracies in data records and reporting including results of the data review for drugs distributed to the United States. Include a detailed description of the scope and root causes of your data integrity lapses.”

The FDA understands that mistakes can be made and there has to be a way to correct them, but any correction should be done in a way that a complete traceability is ensured. A way to do that is to show the old annotation, the new one, a signature, the date and a justification of the change. That has been an established rule from the very beginning as far as working with handwriting documents goes.

The question is how to implement the same principle in a software solution. The answer is to have a complete Audit Trail system that has to reflect all activities performed on the system.

Basically all data entry or modification has to be identified with the person, date and reason for the action. So, how does SherpaPharma approach the data legibility?:

  • The system tracks every entry that is done on the system both from the website and from the hand device. Every action is clearly registered and can be tracked.
  • The main information of a sample, once it has been entered, is blocked and it is no longer possible to modify it.
  • Only some personnel, with an adequate predefined role, can modify data. This modification is done adding a remark to explain the reason behind the change. To perform this action the user has to identify themselves using their password.
  • In the Audit Trail page, the system keeps the old value, the new value, the person who performed the modification and the reason behind the change.
  • The Audit Trail page can be filtered to easily find the information and it can be approved by a Responsible.

Figure 1: Audit trail information can be filtered to easily find the information needed


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