ALCOA+ PRINCIPLE? 1)Attributable 2)Legible 3)Contemporaneous 4)Original 5)Accurate 6)Available 7)Enduring 8)Complete 9)Consistent.

2.  The ALCOA acronym was introduced by stan W.
Woollen in the FDA Officer early 1990’s.
 Commonly used in the pharmaceutical sector.
ALCOA+ PRINCIPLE?
1)Attributable
2)Legible
3)Contemporaneous
4)Original
5)Accurate
6)Available
7)Enduring
8)Complete
9)Consistent.

3. 1)Attributable
 Clearly indicates who recorded the date/ performed the
activity with sign date (Manually/Electronically).
Dedicated log in Functionality which fulfils this
requirement by providing each user with unique name
and password.
2)Legible(Readable)
 Date should be readable after it is recorded. Date is
recorded permanently in long-lasting (durable) medium
like a pen, non-removable ink. This applicable for both
printed and handwritten documents.

4. 3)Contemporaneous(online Record)
 Record the date at the time it was generated,i.e
Contemporaneously.It is well known online recording
of date.
4)Original
 Prevent date in its unaltered state like raw date. This is
the first date generated electronically or manually.
5)Accurate
 Date reflect its actual value truness, free from error.
Accuracy of date indicateds quality.

5. 6)Available
 Date should be available for review at any time until
the defined storage of the document. Available at the
time of audit and whenever required for review.
7)Enduring
 Making sure records exist for the entire period and
readable condition.
8)Complete
 All recorded date requires an audit trail to show
nothing has been deleted or lost.
9)Consistent
 This primarily Means ensuring date is chronological,
i.e has a date and time stamp that is in the expected
sequence.