Nowadays, data integrity issue is 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 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 in 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 1990's Stan W. Woollen introduced the word ALCOA which is mostly used in the pharmaceutical sector.
Attributable: What do you mean by attributable? It means the analyst who has performed the activity, his/her name should be written with signature and date. If anybody reviews, and approves the data their name and signature with the date should their. It may be in electronic or manual form. It is applied to both 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 also can read and understand.
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 which are generated for the first time is known as original. Avoid any raw, source data in an unaltered form. Xerox copy of any original data is 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, Consistent.
Complete: Data should be complete so that are no chance of manipulation. Any raw data or record provided to others the all the supporting data must be attached there. When you perform an analysis the data must contain weight slip, method or process applied for testing, instrument-generated data, HPLC sequences, and chromatogram data.
Consistent: Data that is available 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 consistent order.
Enduring: It means data should be long-lasting. It must be in clear and readable form for a specified period or until the lifecycle of the product. Data may be on the worksheet or notebook. In some printing data, ink evaporates after some time so nobody can read and understand what was written, which means it is not durable.
Available: Data should be available when it is required and until its validity. 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 of Interrelationship between Data Integrity & Task to be delivered
- Establishment of Data Integrity structure & Data Governance
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