ALCOA++: What’s New, What’s Important, and  What You Need to Know

by: Willis Thomas, Learning & Development, Liasion Officer, Senior Associate Partner

The acronym ALCOA stands for Attributable, Legible, Contemporaneous, Original, Accurate. It has been reported, that the term was introduced by Stan W. Woollen (Senior Compliance Advisor and Associates) in the FDA office in the early 1990's. Later, the European Medicines Agency (EMA) added four more requirements that focus on data management: Complete, Consistent, Enduring and Available.  This step of continuous quality improvement earmarked the name of ALCOA+.  

Most recently, Traceable has been added to this list, resulting in the new acronym ALCOA++ that should be used going forward starting now in 2023.

Alcoa++_Site PQE

ALCOA++ principles 

  1. Attributable: Who acquired the data or performed an action? 
  2. Legible:Can you read the data and any laboratory notebook entries?
  3. Contemporaneous: Was the data documented at the time of the activity?
  4. Original: Is the data an original record or observation, or a certified copy thereof?
  5. Accurate: Are there any errors or editing without documented amendments?
  6. Complete: All data, including any repeat or reanalysis performed, is recorded
  7. Consistent: All elements are dated or time stamped in expected sequences
  8. Enduring: Data is recorded in official laboratory notebooks and/or electronic media
  9. Available: Data record is available for review, audit, or inspection, over its lifetime 
  10. Traceable: Data should be traceable throughout the data life cycle, and changes should be recorded as part of the metadata (i.e., audit trails) 

The added principle - Traceable

Each organization is now tasked with updating their annual compliance training that incorporates Traceability. This involves not only good documentation practices, but transcends every aspect of the quality system to include areas such as data governance. Integrally important to traceability is a comprehensive assessment of compliance with CFR 21 Part 11 and how an organization is managing its repository for e-signatures, short and long term records archival as well as paper hard copy documentation.

PQE Group has demonstrated operational excellence in this area by helping companies on a global basis to realize the benefits of harmonizing and standardizing their processes to adhere to regulatory guidelines while following industry best practices. 

Examples of questions an organization should ask about traceability include: 

  • When was it transferred? 
  • How was it stored? 
  • Where are the storage facilities? 
  • Why was this returned? 
  • Who was the person that signed for the product? 
  • Which pallet is in question of the lot that was damaged? 

As organizations consider their forward and reverse supply chain processes and systems used to support business operations, it is imperative that they are able to answer all questions regarding traceability as part of new serialization requirements set forth over the past several years.

PQE Group can support your needs, educate your personnel, and ensure compliance for your product development and manufacturing. Call us to discuss ALCOA++ and how we can help your business. 


Are you compliant ?

PQE Group can support your business to be compliant with all the ALCOA++ principles.

To get more information or support, check our Data Integrity dedicated page or get in touch with us to find the most suitable solution for your company.

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