What is Data Integrity?
Before we explore ALCOA and ALCOA+ we must delve into Data Integrity first. Data Integrity is a commonly used principle wherever data is used. the “Integrity” in Data Integrity should not be confused with morals or honesty. In this context “Integrity” means “wholeness” and “unity”.
Data integrity is the maintenance of, and the assurance of, data accuracy and consistency over its entire life-cycle. The GxP’s require manufacturers and distributors of medicinal products to apply the Data Integrity principles to the data they generate. Although “Data Integrity” itself isn’t mentioned in the EU GMP, we must apply it’s principles to our data.
Data Integrity Principles
Data Integrity aims to ensure that data is accurate and consistent over its entire life-cycle. To see how this principle is translated to the pharmaceutical industry we must examine Chapter 4 of the EU GMP on Documentation. Four paragraphs in particular relate to the principe of accuracy and consistency of data;
- §4.7 Handwritten entries should be made in clear, legible, indelible way
- §4.8 Records should be made or completed at the time each action is taken and in such a way that all significant activities concerning the manufacture of medicinal products are traceable.
- §4.9 Any alteration made to the entry on a document should be signed and dated; the alteration should permit the reading of the original information.
- §4.10 It should be clearly defined which record is related to each manufacturing activity and where this record is located. Secure controls must be in place to ensure the integrity of the record throughout the retention period and validated where appropriate.
These paragraphs (amongst others) focus on the fact that data should be: attributable, legible, contemporaneous, original and accurate. In short; ALCOA!
ALCOA is an abbreviation of;
- Attributable – (identifiable). The person entering the data must always be traceable. This also applies to making/doing; corrections, deletions, additions, etc.
- Legible – (readable). In the broadest sense of the word. Applies to all information which should be complete.
- Contemporaneous – (synchronous). Evidence of actions, events or decisions performed must be simultaneously documented.
- Original. The original record is the first time the data is recorded. This information must remain available in its original state.
- Accurate. Can be achieved through good procedures, qualification and calibration, data review procedures and sound scientific substantiation.
As if ALCOA wasn’t enough, some companies use ALCOA+. The “plus” adds four more words to the mix; Complete, Consistent, Enduring and Available. That would make the full abbreviation; ALCOACCEA, which isn’t very catchy. That’s why the “+” is added at the end of ALCOA. The reason for these additions is that some felt that ALCOA in itself wasn’t sufficient to fully implement the Data Integrity principle.
Let’s examine the additions in more detail:
Complete. All information needed to reproduce a event is important for understanding the event. Metadata is an important element. The more critical the event, the more information must be collected for the data to become meaningful (and complete).
Consistent. Good Documentation Practices must be implemented in every process.
Enduring. Records must be available for the entire period for which they are intended. This means that they must remain intact, accessible and readable.
Available. Records must be available for the entire period for which they are intended. Review must be possible, in an accessible and readable format, for all personnel responsible for it. Whether for routine release decisions, investigations, trending, annual reports, audits or inspections.
One could argue that ALCOA is merely a tool and not an all-encompassing solution to the Data Integrity issue, companies should implement all data integrity requirements and not solely rely on a nice abbreviation. Whatever your stance on ALCOA versus ALCOA+, you can always fall back on Chapter 4 of the EudraLex Volume IV, or any other leading guideline such as;
- PIC/S – Good Practices for Data Management and Integrity in regulated GMP/GDP Environments
- MHRA GMP GXP Data Integrity Guidance and Definitions
- USFDA –Data Integrity and Compliance With Drug CGMP
- APIC – Practical risk-based guide for managing data integrity
- WHO guidance on good data and record management practices
- EMA Q&A (website)