Data integrity, an area of increasing priority in today’s laboratory world and “The focus area” when it comes to regulatory compliance such as 21 CFR Part 11 and Eudralex Annex 11. Considering the number of warning letters from USFDA and other such regulatory bodies issued to pharmaceutical and medical devices manufacturers across the globe, Data integrity is the “Buzz word” in today’s audit.
WHAT IS DATA INTEGRITY?
Data integrity refers to the overall completeness, accuracy and consistency of data during its entire life cycle. Though seems simple, the whole process of genuinely generating, maintaining & transforming data with completeness and accuracy is a challenging task for any organization. This white paper discusses the issues faced by organizations in achieving data integrity and briefly describes how and what technology can be effectively used to achieve better data integrity.
PROBLEMS FACED BY ORGANISATIONS IN UNDERSTANDING DATA INTEGRITY
Most organisations figure out the process of data management which will include capture and archival but fail to understand the core requirement in accomplishing its integrity. For data integrity, it’s important to know the “data architecture” of the system. This understanding is key in setting up the focus area and methodologies to achieve better integrity.
DATA INTEGRITY GUIDELINES BY REGULATORY BODIES
FDA has been adopting the ALCOA attributes to verify data integrity
- Attributable – Defining Source data and who performed an action on it.
- Legible – Permanent recording of information and Access to easy reading any time
- Contemporaneous- Recording the date & time when work is performed
- Original – Justifying if the information / data is a true copy
- Accurate – Is the data accurate, with no errors or editing
Click here to download the documents.