The digitisation of pharmaceutical processes has brought many advantages, such as the speeding up of data searches from any location, as well as the facility to generate backup copies.

ALCOA concept, key to ensuring data integrity in the pharmaceutical industry.

Until some years ago, the pharmaceutical industry, as all other industries, used to register the information generated during the production process in paper.

Today, however, laboratory notebooks, master recipes, batch and procedure records, among others, are no longer stored as written or printed documents, but have been digitised.

The digitisation of pharmaceutical processes has brought many advantages such as the potential to find data more quickly and from anywhere or to make back-up copies.

But this digital culture also involves certain risks related to data integrity in the pharmaceutical industry. For this reason, the pharmaceutical industry must follow certain procedures to ensure data integrity.

What is ALCOA(+)? Data Integrity and Business Risk Reduction

Good data management is one of the most important objectives of the pharmaceutical industry.

The ALCOA concept is common in this sector, as it provides a framework under which companies can guarantee the quality and security of data, as well as of the processes related to the documentation and handling of sensitive data with which they work digitally or on paper.

Regulatory agencies such as the FDA (Food and Drug Administration) or the EMA (European Medicines Agency) recommend following ALCOA principles in order to comply with data integrity in the pharmaceutical industry.

What is ALCOA ?

To ensure Data Integrity or data integrity in the pharmaceutical sector, it is necessary to comply with the indispensable principles known as ALCOA.

The FDA uses the acronym ALCOA+ to refer to the attributes that data must have to be accurate and consistent, ensuring that it is attributable (who recorded the data and when it was recorded), readable (at the present time and in the future), contemporaneous (recorded at the time it was obtained) and original (or, failing that, validated copies), among others.

Complying with the conditions provided by the ALCOA+ rule to guarantee data integrity helps to reduce the risk of business in the pharmaceutical sector. In this way, you are prepared to face inspections by the authorities that seek to ensure that you comply with the data integrity guarantee in the data lifecycle.

The five main aspects of data management are as follows:

Data must be attributable.

When data is recorded, manipulated or deleted, it must be recorded which professional or machine made the change. Data must be attributed to a person or device in order to maintain traceability, and it must be possible to know on what date the record was made.

With attributable data, it is clear who made the record, when it was made and why, and whether the data was created or a change.

With suitable software, it is possible to indicate who made the record and when. For example, when a drug is dispensed in a pharmacy, a record should be kept of which pharmacist made the sale and the date and time it was made. In this way, this information can be traced over time.

The data must be legible (readable).

The readability of the data refers to the possibility that anyone reading or analyzing it will be able to understand it. The record, in addition to being understandable, must be permanent and accessible throughout its life cycle. This condition also applies to metadata that must be human-readable.

An example of this attribute in the pharmaceutical industry can be found in the documentation of a process where each of the steps carried out during the process are described in detail, in clear and concise language that allows anyone who reads it to understand how the process was carried out.

It is also important to take into account the manual records that are made so that they are understandable and legible. An example of this type of records can be found in the annotations that are made in the work records of quality control laboratories, which must be understandable to anyone who reads them.

The data must be contemporaneous.

Data should be recorded at the time they are generated. This is a fundamental requirement for data integrity, since it prevents the information from being inaccurate because it could be contaminated by the passage of time. Computer systems help to record data automatically at the time, helping to ensure that the data are stored accurately and reliably.

In a clinical trial, the data obtained in each of the tests performed must be collected at the time they are produced, in order to do so accurately and correctly, and so that the result of the trial is not altered or deteriorated.

The data must be Original (original)

The originality of the data refers to the need for the source of the records to be the original, where the first record was housed or generated. The data must show its original date of creation, as well as all the modifications that have been made to it, in order to maintain the traceability of the changes and facilitate their analysis.

In many cases, manual records are made and then digitized. It is important that the recording of these data takes this aspect into account and records the main source from which the record was made.

The data must be accurate.

The data must not contain any errors and must be accurate and precise. Changes made to the data should always be documented and the changes made should be noted to facilitate understanding and maintain accuracy.

Records are not deleted from the original information or crossed out in the event of changes or errors. The original data is always maintained and information related to those modifications is added, always indicating the reason for the change.

Nowadays, it is common to have Audit Trail in the computerized systems used. With this it is possible to follow, for example, the steps that have been followed in a drug manufacturing process, passing through its distribution to the pharmacy, until it reaches the end customer.

All the information generated during this life cycle must be recorded precisely and accurately in order to have a correct traceability back and forth of a complete process.

By meeting ALCOA’s five attributes for data recording and management, a business reduces its risks and increases the integrity of the sensitive information it handles. With the use of advanced IT tools, data recording processes can be automated to help comply with ALCOA rules.

ALCOA+ is a set of principles aimed at ensuring data integrity. The five concepts on which this rule is based are that data must be accurate and correct, it must be identified with the author of the data, it must be understandable, it must be recorded the first time it is observed or generated and it must be documented in the corresponding record immediately.