(published in Dec 2018)
The purpose of this guidance is to
clarify the role of data integrity in current good manufacturing practice (cGMP)
for drugs, as required in 21 CFR parts 210, 211, and...
Coined By: - Stan Woollen in Early 1990s.
1999 FDA Guidance:-
ALCOA- To be acceptable; the data from the Clinical Trials should meet certain fundamental elements of quality whether collected or recorded electronically...
Attributable means information is captured in the record so that it is uniquely identified as executed by the originator of the data (e.g. a person or a computer system).
The acronym ALCOA is used by regulated industries as a framework for ensuring data integrity, and is key to Good Documentation Practice (GDP). ALCOA relates to data, whether paper or electronic, and is defined...