Nowadays, data integrity issues are the most common issue in the pharmaceutical sector. Data integrity is very important in the pharmaceutical industry. This topic will describe data integrity, data integrity breaches, Alcoa, and the Alcoa Plus Principle.
What is data integrity?
''Data'' means any recorded raw information, and ''integrity'' means recording of data honestly. Data integrity means data are complete, consistent, accurate, trustworthy, and reliable throughout the lifecycle. Data integrity works on the principle of ALCOA plus. Data integrity means recording the right information even in the absence of CCTV or another person. Data includes all original records, true copies, source data, metadata, and reports that are recorded during the activity.
What is ALCOA?
ALCOA stands for Attributable, Legible, Contemporaneous, Original, and Accurate. In the FDA office, in the early 1990s, Stan W. Woolen introduced the word "ALCOA," which is mostly used in the pharmaceutical sector.
Attributable: What do you mean by attributable? It means the analyst who performed the activity should be identified with a signature and date. If anybody reviews and approves the data, their name, signature, and date should be included. It may be in electronic or manual form. It is applied to both the original and any changed data. It covers all the information about what is performed, who has performed the activity, and when the activity was performed.
Legible: Data may be manually written or electronically generated. Data should be neat, clean, and clearly written so that other people can read and understand it.
Contemporaneous: It means real-time analysis or online record. You have to record the data at the time of analysis. If you performed any activity now, you are not allowed to record that data tomorrow or the day after tomorrow. If you don't record at the same time, there will be data integrity issues.
Original: Any raw data that is generated for the first time is known as original. Avoid any raw source data in an unaltered form. Xerox copies of any original data are not recorded.
Accurate: Data indicates its actual value and trueness and should be free from error. For example, when an analyst performs the assay analysis test, he/she takes a specified quantity of test samples and references standards for analysis that should be noted. For accurate results, they should put that value in the calculation.
What is ALCOA+?
ALCOA is updated with the latest information, which consists of 4 more words: Available, Enduring, Complete, and Consistent.
Complete: Data should be complete so that there is no chance of manipulation. Any raw data or record provided to others must include all supporting data. When you perform an analysis, the data must contain a weight slip, the method or process applied for testing, instrument-generated data, HPLC sequences, and chromatogram data.
Consistent: Available data must be in a sequential manner with proper sign and date. Good documentation practices are necessary for accurate data. When you perform any analysis, there should be a consistent order.
Enduring: It means data should be long-lasting. It must be in a clear and readable form for a specified period or until the lifecycle of the product. Data may be on a worksheet or in a notebook. In some printed data, ink evaporates over time, so nobody can read and understand what was written, which means it is not durable.
Availability: Data should be available when it is required and for as long as it is valid. It should be available when any regulatory authorities audit the industry.
What are the root causes of data integrity?
- Performance & business pressure
- Lack of awareness or capability
- Data integrity is not fully integrated into our culture
- processes & technology
How to ensure data integrity?
- Education / Training & Communication
- Understanding & Detecting Risks / Gaps
- Bridging the Interrelationship between Data Integrity & the Task to be Delivered
- Establishment of Data Integrity Structure & Data Governance
