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Data Integrity ALCOA++ defines a framework to achieve data integrity, especially important for regulated industries. |
Data integrity can be thought of as a component of a larger process ensuring the security, traceability, and quality of an organization's results over their whole lifecycle. The principles outlined in ALCOA, ALCOA+, and ALCOA++ support efforts toward data integrity and include ensuring that data is attributable and traceable, among others.
Based on the ALCOA, ALCOA+, and ALCOA++ framework we have developed a poster to help ensure data integrity in every laboratory.
Laboratories, universities, and companies are working intensively to improve data management and data integrity in their daily work. Connectivity with technologies such as Wi-Fi, Ethernet, or Bluetooth® between lab equipment, lab technicians, and students plays a key role.
Data can be collected by hand or electronically. Irrespective of the method, it's essential that records be original. Manually-recorded data that needs to be transferred into a spreadsheet and then analyzed with non-attributable information poses a risk. Likewise, data validity will be compromised when, for example, employees sign on behalf of others, data is incomplete, or records aren't secured.
The ALCOA++ Data Integrity principles come from the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) guidelines, and other regulatory authorities. They are designed to overcome the challenges in maintaining data integrity, particularly with electronic records.
The acronym of data integrity ALCOA++ defines a framework to achieve data integrity, which is especially important for regulated industries
ALCOA is an acronym based on the following five principles:
- Attributable: Record the person or system that performed an activity.
- Legible: Data must be readable throughout the entire lifecycle of the record.
- Contemporaneous: Documented at the time of the activity.
- Original: Record is original or certified true copy.
- Accurate: No errors of editing without documented amendments.
In addition to the core ALCOA principles, data should also be:
- Complete: All data, including all tests, repetition, or reanalysis, must be documented.
- Consistent: All components of the analysis, such as a sequence of events, are followed.
- Enduring: A sustainable record (systematically documented) in a validated system.
- Available: Data can be accessed for review, audit, or inspection over its lifetime.
All these principles working together help organizations comply with ALCOA+ with their data. More recently, EMA guidelines on computerized systems added a tenth ALCOA criterion, making it ALCOA++:
- Traceability: Data is traceable throughout the process and life cycle, including changes.
