Data Integrity
Download as PPTX, PDF1 like685 views
Data integrity ensures the completeness, consistency, and accuracy of data. It is defined by the ALCOA principle of data being Attributable, Legible, Contemporaneous, Original, and Accurate. Violations can occur through errors, falsification, or fraud. To reduce violations, facilities must address Motive, Opportunity, and Means - ensuring staff do not feel rushed, limiting single logins, and preventing edits to records. ALCOA was expanded to ALCOA+ by adding Complete, Consistent, Enduring, and Available to better ensure data integrity over the long-term.
Data Integrity
- 1. DATA INTEGRITY NAME : SIRSHENDU ROY
- 2. WHAT IS INTEGRITY ? • Integrity is the practice of being honest and showing a consistent and uncompromising adherence to strong moral and ethical principles and values. In ethics, integrity is regarded as the honesty and truthfulness or accuracy of one's actions.
- 3. WHAT IS DATA INTEGRITY ? • Data Integrity is defined as, “the completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be Attributable, Legible, and contemporaneously recorded, Original or a true copy, and Accurate.” • This is also known as the ALCOA principle guiding Data Integrity.
- 4. DATA INTEGRITY VIOLATIONS • Data Integrity violations or data errors can happen in 3 ways: fat finger errors (an accidental lapse by an operator), falsification (a rogue operator who enters false results) and fraud (collusion by a number of people). In this blog post, we’ll investigate how to reduce the risk of all three. • As a manager in a GMP facility, you are responsible and accountable for data integrity. If a regulator detects data integrity violations at your facility, then it will take a long time and a lot of work to regain that broken trust. • This can only be achieved with proper design, the application of QRM principles and the training of your staff.
- 5. WHERE TO START TO REDUCE DATA INTEGRITY VIOLATIONS? • To reduce the risk of data integrity violations, think MOM – Motive, Opportunity and Means.
- 6. MOTIVE • The motive to commit a data integrity violation can come from a number of sources. Often it’s that drive to reach production targets and get product out the door that can lead to disastrous unintentional consequences. • It could also be a lack of resources, so staff are rushed and make mistakes. It could be due to personal issues for staff as such a crisis at home or a health issue. One statistic published a few years ago claimed that 25% of all products recalled in the US were batches released in the last 3 days of a quarter.
- 7. OPPORTUNITY • Opportunities for data integrity errors can be controlled, but must be balanced with the practicalities of staff requiring access to perform their duties. • Auditors often see staff using a single log on (with the password written on a Post It note beside the terminal for handy reference!), a lack of group access policies with monitoring and enforcement is also common. • Any computer system with GMP implications should have access level rules established and enforced. These rules should define staff roles, responsibilities and authorities, including those required for effective data governance programs.
- 8. MEANS • The means to change or falsify data is perhaps the easiest to control. Technical controls such preventing operators from making time and date changes (on any equipment), removing the Windows snipping tool (the electronic equivalent of White Out), not allowing any PDF editing tools, and preventing analysts from deleting files are all easy to implement.
- 9. ALCOA TO ALCOA PLUS FOR DATA INTEGRITY • ALCOA was coined by Stan Woollen in early 1990’s. FDA guidance in the year of 1999. • ALCOA was an tool to implement the data integrity in pharmaceutical manufacturing facility but ALCOA+ made this tool more powerful and sharp. • The term ALCOA is an Acronym, which stands for Attributable, Legible, Contemporaneous, Original and Accurate. ALCOA was then expanded to ALCOA +, by addition of few more concepts which are; Complete, Consistent, Enduring and Available.
- 10. ATTRIBUTABLE • Attributable dictates that any data should be easily identified to the person who did the data collection, place of origin and the time of data collection should also be noted down. In the case of alteration of data, the person making the corrections should also be noted down.
- 11. LEGIBLE • Legible data means the data can be easily read. This attribute should be ensured both in the short and long term, therefore the materials used in recording and collecting the data should be durable.
- 12. CONTEMPORANEOUS • Data recorded should be contemporary in nature. The dictates that the time of data collection should correspond accurately with the time of data recording. Any data collection should have a date and time, and the same should be ensured in the case any later corrections.
- 13. ORIGINAL In order to preserve the meaning and integrity of data, the original records should be preserved, meaning the material used should be durable. In the case of duplicates, the creator of original records should confirm the authenticity of the copies.
- 14. ACCURATE For any data to be viable, it should be error free. In the case of any amendments, there should be accompanying documents to support the changes. The data should be complete and viable. Data quality must be maintained.
- 15. COMPLETE When data is complete in nature, it means there is no deletion that has taken place from the date of documenting. This includes any changes that have been made during the life of the data.
- 16. CONSISTENT The data should be chronologically arranged, with time stamps included for any addition to the original data. Consistency should be ensured by applying various audits over the life of the data.
- 17. ENDURING The material used to record the data should be in a manner which will last a long duration of time without losing the readability.
- 18. AVAILABLE Data should be accessible whenever needed, over the life of the data. Availability ensures the data meets its use, since it can be applied when the need arises.