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It means that the name of the person who compiled the data along with date and time should be mentioned. Attributable – The information captured in a document should be attributable to a specific person.The ALCOA guidelines put down by good documentation guidelines are applied to all forms of documentation and evidence maintained such as paper, electronic, and hybrid. ALCOA guidelinesĪLCOA is short for the essential characteristics of good documentation – Attributable, Legible, Contemporaneous, Original, and Accurate. For data integrity, WHO made simple ALCOA guidelines that every regulated industry needs to follow to keep their data safe, readable, reliable, and retrievable. As data integrity is top priority for industries to produce quality products, regulatory agencies like FDA inspect and issue 483 forms and warning letters to industries that do not ensure data integrity. But raw data needs to undergo different formats to facilitate informed decisions. Data helps in finetuning quality processes, finding current and future trends of production, analyzing quality of products, and driving business decision making. In turn, data integrity ensures recoverability, accessibility, traceability, and availability of data anytime for any purpose. Documents if saved properly ensure data integrity.
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Maintaining data integrity in Pharmaceutical industry is crucial for several reasons. Highly regulated industries have the responsibility of ensuring data integrity in the entire lifecycle of documentation. As per Food and Drug Administration (FDA), European Medicines Agency (EMA), Medicines and Healthcare items Regulatory Agency (MHRA), World Health Organization (WHO), and other regulatory bodies, data has no value if it is not preserved properly.