Ensuring data integrity through ALCOA+


Werum’s Data Integrity & Compliance Team

The acronym ALCOA+ has been around since the 1990’s, is used by regulated industries as a framework for ensuring data integrity, and is key to Good Documentation Practice (GDP). ALCOA+ relates to data, whether paper or electronic, and is defined by US FDA guidance as Attributable, Legible, Contemporaneous, Original and Accurate. These simple principles should be part of your data life cycle, GDP and data integrity initiatives.




What is data integrity?
Data integrity is key in the pharmaceutical andbiotech industries to ensure that the end products meet the required qualitystandards. It is the process of maintenance and assurance of accuracy andconsistency of the data over its entire life cycle.

Data integrity is critical to the design, implementation and usage of any system that stores, processes or retrieves important data. Unless the integrity of the data collected and recorded by pharmaceutical manufacturers isn’t maintained, you cannot ensure that you are producing high quality and safe products. To maintain the integrity of data, you must protect it from accidental or intentional modifications, duplication, deletion and falsification.

Requirements related to data integrity are not only addressed from a functional, i.e. pharma manufacturing point of view but also in regards of activities related to the software development.

Importance of data integrity
Data integrity has always been a delicate topic in the pharmaceutical and biotech industries but it has gained more importance recently. Violations related to data integrity have led to numerous regulatory actions such as alerts and warning letters. In fact, a large fraction of warning letters issued by FDA is related to data integrity. Due to strict measures and technological developments, data integrity is getting more and more acute.

Boosting your data integrity with MES
The usage of an electronic manufacturing execution system (MES) like Werum’s PAS-X enables pharmaceutical and biotech manufacturers to fulfill data integrity requirements. For instance, audit trails in an electronic system make it obvious who created a record, when it was created, who made a change, when the change was made, and the reason a change was made. An MES automatically tracks this information: Data is attributable to a unique user with a secure password and role-based permissions, preventing changes from being made by unauthorized users.

Another example is that the use of an MES enables pharma companies to have less human interventions, which reduces the chances of human errors. And it has interfaces to other systems to automatically fetch values of activities. This way, the system ensures that the data fetched or pulled from surrounding systems is correct. Audit trails and batch reports are functionalities, which enable manufacturers to review everything so that they can ensure that data recorded is truthful.

With this key role, using an MES will boost your data integrity compliance and process quality, since your data is attributable, legible, contemporaneous, original and accurate!

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