ALCOA+ is an acronym that stands for Attributable, Legible, Contemporaneous, Original, Accurate, and the '+' refers to Complete, Consistent, Enduring, and Available. These principles form a critical checklist to ensure that data is trustworthy and reliable. Here's a brief overview:
- Attributable: All data should be traceable to the person who generated it.
- Legible: Data and its metadata should be readable and understandable.
- Contemporaneous: Data should be recorded at the time of the activity.
- Original: Original data or its certified copy should be available and accessible.
- Accurate: Data should be correct and without any errors.
- Complete: All data, including any repeats or reanalysis, should be recorded, and retained.
- Consistent: All data set elements should be logical and in harmony.
- Enduring: Data should be recorded in a durable format.
- Available: Data should be retrievable and accessible for the period required to be retained.
By embracing the ALCOA+ principles, organisations can significantly enhance their data integrity assurance, meet regulatory expectations, and ensure the quality of their products or services.
Regulatory agencies like the FDA, EMA, and MHRA have set comprehensive guidelines to ensure data integrity in regulated environments. They underscore the need for data to remain accurate, consistent, and reliable throughout its lifecycle, emphasising principles like ALCOA+.
Regulations such as FDA’s 21 CFR Part 11 and EU’s Annex 11 set specific requirements for electronic records and electronic signatures, enforcing strict controls over data documentation and modifications. For instance, audit trails are obligatory to track and document any changes made to the data, protecting it from unauthorised alterations.
However, it's worth noting that the requirements for Data Integrity go beyond electronic data. Paper-based records must also adhere to the same rigorous standards to ensure their integrity.
Understanding and implementing these regulations are pivotal in maintaining Data Integrity and regulatory compliance.
Regular monitoring is a key part of maintaining data integrity. It ensures that the organisation complies with regulatory requirements and that potential issues are detected and addressed promptly. Here are a few red flags that might indicate potential problems with data integrity:
1. Unexpected or Unexplained Changes: Any unexpected modifications in data sets or unexplained changes to documentation should be thoroughly investigated.
2. Inconsistencies in Data: If the same data appears differently in different places or if there are discrepancies between electronic and paper records, it may signal a data integrity issue.
3. Frequent System Errors or Failures: Regular occurrences of system glitches could indicate underlying problems that could compromise data integrity.
4. Access by Unauthorized Individuals: Unauthorized access to data systems is a clear red flag. Regular audits of access logs can help identify such incidents.
Addressing these red flags involves a few key steps:
- Investigate: Analyse the cause and extent of the problem.
- Correct: Implement solutions to rectify the issue.
- Prevent: Put measures in place to prevent the issue from reoccurring.
Remember, maintaining data integrity is not a one-time event but an ongoing process that requires continuous vigilance.
Read also: Is the Data Integrity a Regulatory Requirement?
Resource Person: Joseph Turton
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