July/August 2018 • www.cemag.us 9
fied, maintained, archived, retrieved, or transmitted
according to requirements set in FDA regulations.
Electronic records/signatures that meet Part 11
requirements may be used in lieu of paper records.
The document is divided into three parts:
General Provisions: The General Provisions section gives an overview of the terminology used throughout the document and the types of records that apply
and do not apply.
Electronic Records: Signed electronic records shall
• Signer’s printed name
• Date and time when the signature was executed
• Signature’s meaning (such as review, approval,
responsibility, or authorship)
Computerized systems must be validated to
ensure data accuracy, reliability, and consistency, and
must be able to discern invalid or altered records.
They also must generate an accurate, complete, and
human-readable copy of the records. Access must be
limited with the use of an ID and password.
Those who develop, maintain, or use electronic
record/electronic signature systems must have the education, training, and experience to perform their assigned
tasks, which is essential to guarantee data integrity.
Electronic Signatures: Users who intend to
generate electronically/digitally signed records must
have a controllable form of identification. This control
extends to maintaining a unique password and ID code
(username), periodic password checks/changes, and
configuration of individual and/or group ID privileges
(i.e. differentiation between operator, supervisor and
administrator). For example, it should not be possible
for operators to have database management rights.
ALCOA is an acronym used by the FDA that
stands for Attributable, Legible, Contemporaneous,
Original, and Accurate. 6 The concept behind
ALCOA is that data quality directly impacts product quality, with focus placed on performing tasks
correctly the first time and immediate reporting of
results. As ALCOA is used in many FDA regulatory
documents, it is important to be familiar with what
is meant by each term.
EU GMP Annex 11
As part of the European Union (EU), EudraLex is
the collection of rules and regulations governing
medicinal products (for human and veterinary use).
GMP and FDA Requirements