ALCOA Plus (ALCOA+) is the “Heart and Soul” of DATA Integrity. Data integrity (DI) is an important and Key attribute to ensure compliance with cGMP (Current Good Manufacturing Practice).
Full form of ALCOA and ALCOA Plus
The ALCOA and ALCOA Plus full form is clearly described in the below images. Data Integrity refers to the “Completeness, Consistency, Accuracy, Attributable, Legible, Contemporaneous, Original (True copy), Enduring and Available (ALCOA Plus).
The ALCOA (DATA INTEGRITY) is all about data Quality and Protection. Hence, the pharmaceutical industry is ensuring to comply with the Data Integrity requirements by implementing the ALCOA principles. The Guidance for the industry has been provided by the regulators such as “FDA, EMA, and WHO.
9 Principles of Data Integrity
To understand the guidelines better & clearly, the 9 principles are provided here for reference purposes.
1. Attributable
The data can assign to the individual, who is performing the task.
2. Legible
The data shall be read by eye or electronically. The legible data shall retain in a permanent format.
3. Contemporaneous
The data is created at the time the activity is performed.
4. Original
The data is in the same format as it was initially generated or as a ‘verified copy’, which retains content and meaning.
5. Accurate
The data is true/reflective of the activity or measurement performed.
6. Complete
The data is complete in nature. The data shall maintain throughout the life-cycle of the data by maintaining/ retaining the changes to the original data.
7. Consistent
The data is based on a system that enforces the use of approved data acquisition and methods, reporting, and workflows.
8. Enduring
The data using media (backup) must ensure the records shall maintain and protected.
9. Available
The data shall be accessible whenever needed, throughout the life cycle of the data.
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