ALCOA Plus Compliance for Pharma Data Integrity

Highly regulated industries have the responsibility of ensuring data integrity in the entire lifecycle of documentation. As per Food and Drug Administration (FDA), European Medicines Agency (EMA), Medicines and Healthcare items Regulatory Agency (MHRA), World Health Organization (WHO), and other regulatory bodies, data has no value if it is not preserved properly. 

Maintaining data integrity in Pharmaceutical industry is crucial for several reasons. Documents if saved properly ensure data integrity. In turn, data integrity ensures recoverability, accessibility, traceability, and availability of data anytime for any purpose. Data helps in finetuning quality processes, finding current and future trends of production, analyzing quality of products, and driving business decision making. But raw data needs to undergo different formats to facilitate informed decisions. As data integrity is top priority for industries to produce quality products, regulatory agencies like FDA inspect and issue 483 forms and warning letters to industries that do not ensure data integrity. For data integrity, WHO made simple ALCOA guidelines that every regulated industry needs to follow to keep their data safe, readable, reliable, and retrievable. 

ALCOA guidelines  

ALCOA is short for the essential characteristics of good documentation – Attributable, Legible, Contemporaneous, Original, and Accurate.

The ALCOA guidelines put down by good documentation guidelines are applied to all forms of documentation and evidence maintained such as paper, electronic, and hybrid.   

• Attributable – The information captured in a document should be attributable to a specific person. It means that the name of the person who compiled the data along with date and time should be mentioned. If any corrections or changes are made to the document, the name of the person who did it, time, and place should also be noted. It, thus, helps in making the source or origin of the data traceable.  
• Legible – The data recorded must be legible, traceable, and permanent in nature. The data, particularly in case of handwritten records, should be legible and understandable at any point of time by anyone. It should help in creating a clear picture of the sequential steps followed and allow to reconstruct all the activities by people reviewing the records. Further, these records should be non-erasable and available throughout the data lifecycle.  
• Contemporaneous – When data is recorded is a crucial factor of ALCOA. The data should be recorded at the time it is generated – not before, not after. It helps in checking the consequences of the actions performed. 
• Original – The original data represents the data captured at the source file. All the subsequent data should also be recorded to reconstruct the performed activities. The format of the data should be kept intact throughout the product lifecycle.  
• Accurate – The data recorded should be accurate without any errors. It should be complete, reliable, and valid. All the subsequent changes should be retrievable through audit trail.  

ALCOA Plus in Pharma  

The general regulations around data integrity were in place since 1978. But the acronym ALCOA came into existence in the 1990’s. Since then, the industry has changed dramatically. The generic drug industry developed tremendously, forming more than 80% of prescription medicine in United States alone. Along with it, the development of biosimilars, virtual organizations, contract manufacturing companies, advancements in automation and information technology, and globalization of the industry resulted in the need for re-evaluation of what data integrity means. This now applies to all documentation, regardless of whether it is produced from electronic, paper-based, or hybrid systems. 

Further, the number of citations from regulatory bodies such as FDA, EMA, MHRA, WHO, and others have also increased internationally. All these changes and an increase in data integrity related violations have led to the revival of interest and need to reeducate the industry on the fundamental principles and guidelines regarding the proper control of data. It is an essential step as it deals with the quality and safety of life-saving medicines.  

What is ALCOA Plus? 

As an extension to the ALCOA guidelines, a few more attributes must now be scrupulously followed to ensure data security and integrity. 

• Complete – The data should be complete with all the records of changes, reanalysis performed to the samples in audit trail. The person reviewing the data should be able to reconstruct a complete picture.  
• Consistent -The data should be saved consistently in a particular chronological order with date and time stamps for easy understanding and audit. 
• Enduring – The data must be recorded on such a material that it lasts for very long time. It should be available in proper readable format for decades until the product is in market. 
• Available – The data should not only exist for a long period of time. It should also be accessible and retrievable at any point of time. When the need arises, data should be readily available to put to use.  

Digitalization and Data Integrity  

Data integrity is a crucial factor that can turn tables for any regulated industry if not properly maintained. With automation and technological advancements, many tools & applications can now help the industry safeguard the integrity of their data.  

Ensuring and achieving data integrity is simple with Caliber’s informatic systems. Caliber systems generate and collate data in full compliance with ALCOA +. With CaliberLIMS, the complete laboratory information and details can be electronically recorded, retrieved, and used for future analysis. CaliberDMS helps in ensuring GDP, GMP, and validation by focusing on good documentation practices as suggested by ALCOA Plus guidelines. CaliberAPQR makes annual product quality reviews and audit work simple. Similarly, other Caliber products provide a holistic approach to address data integrity. External auditors can be assured that the documents created or collected in the form of evidence through Caliber systems are valid and true for audit review.  

Choosing ALCOA Plus compliant Caliber products is a simple way of achieving data integrity and ensuring enhanced product quality.  Click here for a free product demo.