Original

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

Primary data or source data is another referral name for Original Data. It refers to where and how the data or information is recorded for the first time.

All the information should be filled in a form, an acceptable protocol, a database, or a notebook. It is crucial to deeply understand the source from which your primary data is obtained to ensure safeguarding of content and meaning.

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

FDA 483 Warning Letter 320-19-29 (July 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 several occasions, you conducted a new analysis after obtaining an initial OOS test result. These analyses included water content tests on a Karl Fischer instrument and an assay test on an auto titrator instrument. We reviewed the electronic data on these instruments and found OOS testing results which were not reported in the analytical records. Only passing results were ultimately included in the data presented for batch review and disposition decisions.

Additionally, your laboratory failed to maintain basic raw laboratory data (e.g., original raw data sheets, original chromatograms, instrument usage logs, original weight printouts) in many instances.

A comprehensive investigation into the extent of the inaccuracies in data records and reporting should be performed.

One of the solutions that the FDA provides is:

An assessment of the extent of data integrity deficiencies at your facility. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your facility’s operations in which you discovered data integrity lapses.

Retaining the original records in a microbiological laboratory is a challenging task since analyses are mainly done manually and have visual detection mode, making it difficult to record these primary data.

The original data can be either agar plates, sterility cannisters or selective broths that cannot be maintained throughout the whole life cycle of the product. Traditional analysis methods do not generate any type of electronic signal that can be stored in a computer or paper record that can be attached to an analysis bulletin. This is one of the reasons that may require a double review of any data obtained through these methods and their transfer to any results management system in the Microbiology laboratory. All these put emphasis on the manual task that is carried out in a laboratory doing an extra task with low value added.

Lately, the use of rapid microbiology systems in which an electrical measurement that can be stored has been making that task easier than before. That implies that a validation of the computer system is critical and must be carried out, ensuring that the value of the original data generated is maintained regardless of the calculations made by the software.

In SherpaPharma, any data entered into the system is saved as the original data. If a calculation must be made later on, due to the effect of the sample volume or the own correction by the measuring equipment, the second value is presented as “calculated value”. It is possible at any time to return to the original data.

All results must go through two levels of revision: reviewal and approval. The Audit Trail records both steps.

Figure 1: Example of Data revision in SherpaPharma

Finally, statistics are performed directly using SherpaPharma Data base, so it is not necessary to transfer to an excel file or statistical software to perform reports. That means that with SherpaPharma you are always working with original data.