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Part 11 Compliance Using Digital Laboratory
Notebook (DLN)
21 CFR Part 11 has
enacted several mandates to ensure the
security, integrity and authenticity of
electronic records and signatures. The
law outlines controls for ensuring that
electronic records and e-signatures are
trustworthy, reliable, and compatible with FDA
procedures. The ultimate goal: Make electronic
records and e-signatures as verifiable and
traceable as their paper counterparts.
Part 11 is not specific to any type of
technology or instrument type, but applies to
all instruments, all applications, and all
operations that generate data electronically
to durable media. Therefore, when a
change is made to a record, the system must
save the old version — not overwrite
information — as well as keep track of the
date, time, data acquisition system
identifier, and user ID of the person that
made the change. In other words, an auditable
version of each change must be available to
ensure data integrity and authenticity.
All organizations must define and implement their own administrative and procedural practices to address the requirements of 21 CFR Part 11. Compliance can be achieved by coupling these practices
with hardware and software
that provide appropriate technological controls. No software or hardware
assures compliance in and of itself. IA's Digital Laboratory Notebook is designed to be a component
of a compliant electronic recordkeeping system.
The DLN is specifically designed and
constructed to integrate readily with closed
systems such as LIMS, office productivity
tools, databases, document management
software, and others, and to provide an
organization with technological controls to
facilitate full compliance. Since procedures and components of an electronic recordkeeping system are unique to every organization,
compliance is a customized process requiring
detailed review of every system and procedure
until all operations satisfy the relevant
parts of 21 CFR Part 11.
IA's Digital Laboratory
Notebook (IA-DLN) is designed to address the
following Part 11 based technological
controls:
Section
11.10(a)
Validation of systems to ensure
accuracy, reliability, consistent intended
performance, and the ability to discern
invalid or altered records.
Section
11.10(b)
The ability to generate accurate and
complete copies of records in both
human-readable and electronic form suitable
for inspection, review, and copying by FDA
Section
11.10(c)
Protection of records to enable
their accurate and ready retrieval
throughout the records retention period.
Section
11.10(d)
Limited
system access to only authorized users of
the system.
Section
11.10(e)
Use of secure, computer-generated,
time-stamped audit trails to independently
record the date and time of operator entries
and actions that create, modify, or delete
electronic records. Record changes shall not
obscure previously recorded information.
Such audit trail documentation shall be
retained for a period at least as long as
that required for the subject electronic
records and shall be available for FDA
review and copying.
Section
11.10(f)
Use of operational system checks to
enforce permitted sequencing of steps and
events.
Section
11.10(g)
Use of authority checks to ensure
that only authorized individuals can use the
system, electronically sign a record, access
the operation or computer system input or
output device, or alter a record.
Section
11.50(a)
Signed electronic records shall
contain information associated with the
signing that clearly indicates the printed
name of the signer, the date and time when
the signature was executed, and the meaning
(such as review, approval, responsibility,
or authorship) associated with the
signature.
Section
11.70
Electronic
and handwritten signatures applied to
electronic records linked to their
respective electronic records to ensure that
the signatures cannot be removed, copied,
transferred or otherwise used to falsify the
electronic record.
Section
11.100(a)
Electronic
signatures that are unique to a specific
individual, and never reused or assigned to
another individual.
Section
11.200(a)
Electronic signatures that are not
based upon biometrics shall: (1) Employ at
least two distinct identification components
such as an identification code and password.
Note: IA's Digital
Laboratory Notebook system also supports a
true biometric based identification and
signature.
Section 11.300(d)
Use of transaction safeguards to prevent
unauthorized use of passwords and/or
identification codes, and to detect such
attempts.
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