Contemporaneous

Following the series of ALCOA+ publications, it is time to review its third concept: Data Contemporaneous.

Contemporaneous implies the recording of the results, data or measurement at the time when the work is being performed. The activities should be dated and stamped at the time of its execution. The date and stamps must come in the order of execution, so if necessary, it will be possible to review the flow process.

When executing a validation protocol, results of tests performed should be recorded in sequence as they happen. The recorded results should then be dated, time stamped and logged in the electronic systems.

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

FDA 483 Warning Letter 320-19-21 (May 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)).

On October 24, 2018, our investigator observed torn documents of stability study data, analytical testing sheets, analysis calculations, and release forms that were placed into clear trash bags. Stability study documents for three batches of (b)(4) mg tablets were salvaged from the trash and compared to the official and approved records. Out-of-specification (OOS) results were among the data found, however the official results were recorded as within specification. Additionally, it was observed that blank stability study forms were prepared, pre-signed, and approved by the quality unit before recording the test data.

In your response, you acknowledged the multiple trash bags containing torn quality control documents and the practice of signing documents before recording the data. You stated the torn documents were from scale-up batches in which you tore the documents so as “not to create confusion in the mind of the investigator.”

FDA asked for a detailed corrective action plan that describes how they intend to ensure the reliability and completeness of all the data that they generate including analytical data, manufacturing records, and all data submitted to FDA.

One of the solutions that the FDA provides is:

  • A comprehensive description of the root causes of your data integrity lapses including evidence that the scope and depth of the current action plan is commensurate with the findings of the investigation and risk assessment. Indicate whether individuals responsible for data integrity lapses remain able to influence CGMP-related or drug application data at your firm.

The general Good Documentation Practice (GDP) states that data / metadata must be always documented at the time the activity is being performed, along with the signature and time stamp.

When the documentation is filled in manually, it is not allowed to backdate or sign with a different code.

Some activities, related with microbiological testing, are not easily recorded manually on a paper template or register at the time the activity is performed. This happens because the action is done in a GMP controlled environment where paper cannot be used.

SherpaPharma system uses a hand device that has been designed to be used in a health care environment and can be easily disinfected with wet wipes and standard disinfectants (IPA, Chlorine solution, ethanol solution,…). The units have the SherpaPharma software installed that can track the environmental monitoring process at the exact time that the activities are being performed. No more paper and pencils are needed in sterile rooms!

Using the hand device, the person who performs the activity and the time that the activity is performed can easily be tracked. The data and time cannot be modified because the system always uses the date and time of the cloud server where all the data is located.

In the following screenshot it can be seen that the person who did the login was “Sherpa Tiselab” and the date of login was on 30th March 2020 at 11:09 (cloud server’s date and time). From now on, while the user is logged in, all the activities performed by that person will be automatically documented with the date stamp and the user code ensuring a contemporaneous data record.