BioPharm International - March2020

BioPharm International - Regulatory

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6 BioPharm International eBook March 2020 www.biopharminternational.com ALCOA+ and Data Integrity Data supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues. D ata supporting the quality and safety of product must meet the ALCOA+ elements in order to avoid regulatory citations for data integrity issues. The acronym ALCOA requires data be attributable, leg- ible, contemporaneous, original, and accurate. The acronym ALCOA+ adds the concepts that, in addition to ALCOA, data also needs to be complete, consistent, enduring, and available. It is important to understand what each element of ALCOA and ALCOA+ mean in order to apply the concepts appropriately with respect to a company's records. The following are some general definitions, para- ph r a s e d f r om t he Ph a r m ac e ut ic a l I n s p e c t ion Co-operation Scheme (PIC/S) (1), that can be used for understanding the elements of ALCOA and ALCOA+: • Attributable: The data generated or collected must be traceable back to the individual who generated the information. • Legible: The data recorded must be readable and permanent. • Contemporaneous: The results, measurements, etc. must be recorded at the time the work is performed. Skórzewiak - Stock.adobe.com SUSAN J. SCHNIEPP Regulatory Sourcebook Data Integrity SUSAN J. SCHNIEPP is executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

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