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Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.
Simplification is crucial to maintain data integrity, according to Siegfried Schmitt, PhD, vice-president, technical at PAREXEL Consulting.
Q. In recent times, several agencies and organizations have published regulations and guidances on data integrity. It is hard enough keeping up with all the requirements and recommendations, and it seems that our processes and procedures are becoming ever more complicated because of these regulations. How can we prevent ‘death by complexity’?
A. Indeed, a lot has been published on the subject of data integrity (1–3), all with the best intentions, but not necessarily always providing the most practical of advice. Or, it may just be hidden in the vast amount of information provided in these documents. For example, a Pharmaceutical Inspection Co-operation Scheme (PIC/S) guidance document (2) states, ‘Examples of factors which can increase risk of data failure include complex, inconsistent processes with open ended and subjective outcomes. Simple tasks which are consistent, well defined, and objective lead to reduced risk.’ In 2016, the World Health Organization (WHO) (4) stated, ‘Good data process design should consider, for each step of the data process, ensuring and enhancing controls, whenever possible, so that each step is: consistent; objective, independent, and secure; simple and streamlined.’
Therefore, it is worth noting that simplification is a strong enabler of data integrity. So how does this work? There are some basic principles that should be applied consistently, such as:
In one example, the records for the cleaning of a controlled area were scrutinized in an audit. According to the records, it was not clear when the operator cleaned a specific room and whether the cleaning was done correctly. The operator had to clean three rooms; this process was always done in a logical sequence, but that was not described in the instructions. As the operator was not allowed to take paper into these areas, the record was only completed once the operator had exited the area. The instructions were 45 pages long, which made it doubtful whether the operator could remember all the steps correctly.
Following the audit, the cleaning instructions for each room were extracted and written in a simple logical sequence. It was possible to fit the new sequence of instructions onto one or two pages (per room), which were laminated and could thus be disinfected and permanently displayed in the respective areas. This way, the operator could consult the instructions whenever necessary. Furthermore, the cleaning logbook was redesigned to show on one line the date and time the operator entered the area, and the date and time the operation was complete, together with a field for any comments (rather than having each entry on a different line and often on different pages of the logbook).
This simple example illustrates that it is not always necessary to change the way operations are performed. What has to be done, however, is to break down instructions into manageable pieces, with tasks unambiguously described and presented sequentially. Why does this help with data integrity? Because it eliminates or prevents errors, reduces the risks of data omissions or errors, and enhances confidence in the system by inspectors.
In summary, though compliance with data integrity regulatory requirements may necessitate some more complex methodologies or systems, simplification of procedures and instructions is a key element of the compliance effort.
1. FDA, Data Integrity and Compliance with Drug CGMP, Questions and Answers, Guidance for Industry (CDER, December 2018).
2. PIC/S, PI041-1 (Draft 3), Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments (PIC/S, November 30, 2018).
3. ISPE, GAMP Good Practice Guide Data Integrity–Key Concepts (ISPE, 2018), www.ispe.org.
4. WHO, Technical Report Series No. 996 (WHO, 2016),www.who.int.
Vol. 32, No. 3
When referring to this article, please cite it as S. Schmitt, "Is Simplification Aiding Data Integrity Compliance?," BioPharm International 32 (3) 2019.