What is ALCOA+?
Data integrity is fundamental in highly regulated industries such as pharmaceuticals to ensure products are of the required quality. The ALCOA framework was introduced by the FDA in the 1990s to achieve this and has since been adopted by regulatory bodies and businesses globally as leading guidance. Now referred to as ALCOA+ thanks to some later additions, the importance of implementing these principles is ever increasing, with enhanced regulatory requirements, high expectations of end-users and a competitive landscape within the industry. Additionally, the principles are becoming vital to Good Manufacturing Practice (GMP).
ALCOA+ is an acronym for:
Attributable: All data must be identified to the person or system from which it was generated or collected, as well as the time of data collection. This information should be recorded again should data be altered.
Legible: data should be easy to read, understandable and permanent. It should not be possible to alter data without an audit trail preserving the original record.
Contemporaneous: the time of data collection should accurately correspond with the time in which the data was recorded – whether for original records or later corrections.
Original: original records should be preserved rather than relying on copies.
Accurate: data should be free from errors, truthful, complete and reflect reality.
Complete: a robust audit trail is required to show no information has been lost or deleted, and any amends to the original data set are visible.
Consistent: data should be chronological with timestamps for amends to the original records.
Enduring: data should be safely stored in a manner which will be available long after it is recorded.
Available: data must be accessible when needed.
Some reports suggest the number of warning letters and statements of non-compliance with GMP citing data integrity alone has tripled since 2013. If not improved, consequences could include temporary suspension of manufacturing license, or in some cases, manufacturing license removal. Luckily there are systems out there such as Microgenetics SmartControl, which can help to make your microbiology lab compliant with MHRA and FDA data integrity guidelines, following the ALCOA+ principles, which can also greatly simplify the Environmental Monitoring process and provide powerful, rapid data analysis. To find out how SmartControl can modernise your microbiology lab, get in touch today for a 15 minute chat with one of our account managers, or to book a demo.