On 2016, documents on Data Integrity and Data Management issued by WHO (World Health Organization Working document QAS/19.819) and the PIC/S (PIC/S, Draft Guidance: Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PIC/S, August 2016).  added to the original ALCOA attributes four new concepts to improve the correct Data Management on Pharmaceutical Companies. Those new concepts have lately been adopted by the FDA and the MHRA on the new Data Integrity guides.

These concepts are not new but improve the standard ALCOA concepts.

The first one is Data Completeness: Data includes all data (passing or otherwise) from all actions taken to obtain the required information, including metadata (e.g., audit trail) and edits

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

WARNING LETTER    Case# 540675  (August 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)).

You recorded results for tests you admitted that you did not conduct. Your worksheets for total aerobic microbial counts and total yeast and mold counts report results for (b)(4) per test, as your microbial limits test procedure requires. However, our investigators found that you used (b)(4) per test. You acknowledged to our investigator that you only use (b)(4) and that reporting (b)(4) results is a “habit” your firm needs to “break.”

Your firm also failed to document critical information on microbiological worksheets. You did not record details of preparing microorganism suspensions for growth promotion testing. You neglected to record incubation times, laboratory materials, and equipment numbers for sample preparation. You did not note how much (b)(4) water you used in your growth media or how many containers you sterilized in the (b)(4) during media preparation

Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. In response to this letter, provide the following:

  • 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.

As we can see, it is important to record complete information to understand the data obtained All metadata must be recorded to be able to track any information in case of any investigation.

With Sherpa Pharma it is possible to track all media information, equipment used during the analysis, incubation steps, original result, different steps of revisions…

All the information is kept into a powerful Audit Trail tool that is very easy to use to track all the activities performed into the system. That implies that in case of any deviation is open, it will be possible to find the correct information to find the route cause of the problem, to implement a CAPA plan and later, with the trending tool, to track if the activities implemented are effective.


Figure 1: Example of Incubation steps and metadata in SherpaPharma