The ALCOA principles are an important reference model in the pharmaceutical sector, and ensure the integrity of both printed and electronic data.
There is no single definition of Data Integrity, but the various bodies have given similar definitions, with the ALCOA principles at the centre.
According to the World Health Organisation (WHO):
“Data integrity is the degree to which data are complete, consistent, accurate, trustworthy, reliable and that these characteristics of the data are maintained throughout the data life cycle. The data should be collected and maintained in a secure manner, so that they are attributable, legible, contemporaneously recorded, original (or a true copy) and accurate. Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices”.
The definition is also used by MHRA, the regulatory agency for medicines and health products in the UK.
We find a similar definition in the FDA document “Data Integrity and Compliance with Drug CGMP. Questions and Answers Guidance for Industry”:
“Data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate (ALCOA)”.
According to the FDA guidelines, ALCOA stands for Attributable, Legible, Contemporaneous, Original and Accurate.
In recent years, these five principles have been supplemented with four more: Complete, Consistent, Enduring and Available. This is why we talk about ALCOA+.
“Who acquired the data or performed an action following the acquisition, and when?”
All data created or collected must be attributable to a person or computer system. This includes who performed the action and when, thus recording the collection or generation date. Recording can be done manually on paper or automatically through the audit trail in a computer system.
“Can you read the data and all the metadata or all the manual transcripts on paper?”
All recorded data must be legible and permanent, ensuring that it is easily accessible throughout the data lifecycle. This aspect of the data is certainly more easily manageable through electronic systems than on paper.
“Is the action documented (on paper or electronically) at the same time as the activity?”
It is essential that individuals or systems record the data at the very moment in which the activity or sequence of activities is carried out. This is a common practice with automated electronic systems, whereas on paper it is more subject to backdating or postdating.
“Certified compliant printouts or copies, electronic records of an activity including the metadata”
The data should be original rather than copies or transcripts. This is especially true for paper records. For example, it is not appropriate to write partial information on a piece of paper, with the intention of completing the record later on in an official document, as this can cause errors. The original record of the data should appear on the master record, regardless of whether that record is on paper or on a digital system.
The data should reflect the reality of what actually happened, be complete and error-free.
Any changes must not obscure or erase the original information. The use of a corrector on paper records is therefore not permitted. Any changes , whether made electronically or on paper, must be signed by the person making the change, dated and provided with a written explanation.
Omissions are regulatory violations! Omission is not so different from “hiding”
A record must contain all the information available up to that moment. All electronically recorded data requires proof that no information has been deleted or lost.
The data/document must be consistent with the use made of it and with the specific features it is expected to have.
The data/document must be long-lasting and therefore adequately preserved.
The data must not only exist, it must be accessible. Electronic data recording is normally the most efficient way to achieve this.
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Simplify the management of Complaints, from filing, through investigation, follow-up, judgment and final report.
The module is designed to provide step by step Quality Assurance support
in the implementation and supervision of the process and the assignment of tasks to the departments involved. The module supplements the CAPA procedure, which the user can open directly from the Complaints procedure.
PRAGMA-WFM documents and traces all activities and information in the Complaints process. In each phase, you can also attach files in various formats to support activities and investigations.
During inspection phases, the functionality dossier enables the real-time generation of a document that provides information and lists the activities of the process and related processes
It simplifies the management of internal and external audits, from planning, through execution, to the management of remarks.
The module supplements procedures for handling CAPAs , Non Conformitiesand Change Control that the user can open directly from the audit to resolve the observations found.
PRAGMA-WFM documents and traces all activities and information of the Audit process. For each process step, it is possible to assign tasks to the people involved, and attach files in various formats.
Duringthe inspection phase, the dossierfunctioncan generate a document in real time which records the information and activities of the Audits and related processes