The acronym ALCOA has been around since the 1990’s, 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 by US FDA guidance as Attributable, Legible, Contemporaneous, Original and Accurate.
These simple principles should be part of your data life cycle, GDP and data integrity
initiatives.
1. Attributable
Attributable, The identity of the person creating a record should be documented. For paper records this is normally done by the individual signing and dating the record with their signature.
As the record you may be signing may be a legal document, you should clearly understand the implication of your signature.
A signature should be individual to a specific individual and the practice of signing someone else’s name or initials is fraud, and is taken very seriously.
2. Legible
A record that cannot be read or understood has no value and might as well not exist.
All records should be composed so they conform to grammatical convention which should be consistent throughout.
It is best to avoid buzzwords, cliques and slang as these are prone to change with time and are often not understood outside a particular locality.
It is always good practice to have any record reviewed by a second person as this can often highlight any ambiguities.
3. Contemporaneous
All records must be made at the time an activity takes place. Delaying writing up, for example until the end of the day, will inevitably affect the accuracy of that record as details can be forgotten or miss-remembered.
4. Original
All records must be original; information must be recorded directly onto the document. This avoids the potential of introducing errors in transcribing information between documents.
If information from an instrument is printed out, by the instrument, that printout is the original record and should be signed, dated and attached to the record.
5. Accurate
The record must reflect what actually happened.
Any changes should be made without obscuring or obliterating the original information, the use of whiteout or correction fluid is prohibited.
Any changes made to a record should be signed by the person making the change and dated to show when it was made and a written explanation should also be provided.
Remember, the record may be needed after you have left the company and cannot be contacted for clarification.