Excel Spreadsheets -How to Ensure 21

CFR Part 11 Compliance?

Spreadsheets
Spreadsheets are
are
aa repository
repository for
for
critical
critical data,
data, and
and
for
for making
making
critical
critical decisions.
decisions.

In
In Microsoft
Microsoft
Excel,
Excel, the
the
workbook
workbook is
is the
the
file
file that
that the
the user
user
creates.
creates.

Each
Each worksheet
worksheet
contains
contains
-calculations,
-calculations,
data
data entry
entry fields,
fields,
audit
audit trail,
trail, and
and
display
display formats
formats
that
that comprise
comprise
the
the application.
application.

What
are
Spreadsheets?

FDA Expectations for Use

of Spreadsheets
All spreadsheets containing GxP or quality data must be compliant with 21
CFR 11 and the data within must be controlled.
21 CFR 11.10: Persons who use closed systems to create, modify,
maintain, or transmit electronic records shall employ procedures and
controls designed to ensure the authenticity, integrity & when
appropriate, the confidentiality of electronic records, and to ensure the
signer cannot readily repudiate the signed record as not genuine.

FDA has stepped up 21 CFR 11 enforcement since late 2010.

Control over system

documentation

Accountability of
signatures

Training/qualification
of personnel

Electronic audit trail

Authority checks

Limited access to
systems and data

Accurate and steady

retrieval

Accurate and
complete copies

Operational system
checks

Device checks

Validation

21 CFR Part 11
Requirements

Which Spreadsheets
should be Compliant?
Spreadsheets that
control GxP data

Spreadsheets used
to make quality
decisions

Clinical: Research
Data, Result Data etc

Documented evidence
of SOPs

Laboratory: Lab Data,

Animal Data etc

Tracking Logs: Internal

Audits, Approved
Supplier Lists,
Approved Batches,
etc.

Manufacturing Data

QA: Quality Assurance

Data

Spreadsheet
containing data that
will be reported to a
Regulatory Agency
Even if it does not fit
the previous 2
requirements

Risk based
approaches apply

Best Practices to Comply

with FDA Requirements
Develop,
Develop,
Protect
Protect
communicate
communicate
spreadsheets
spreadsheets
Prepare
Prepare an
an
and
and enforce
enforce aa
Standardize
Standardize using
using built-in
built-in
inventory
inventory list
list
company
company
development
development
standard
standard
with
with all
all
policy
policy and
and
and
and use
use as
as
software
software and
and
computers
computers
master
master plan
plan
much
much as
as
IT
IT
that
that run
run
for
for
possible.
possible.
infrastructure
infrastructure
spreadsheets.
spreadsheets.
spreadsheet
spreadsheet
(e.g.,
(e.g.,
calculations.
calculations.
client/server).
client/server).

Validate
Validate
spreadsheet
spreadsheet
calculations.
calculations.

Document
Document
and
and justify
justify
your
your
approach.
approach.

Want to learn more about 21 CFR Part 11, its requirements and best
practices to comply with them? ComplianceOnline webinars and
seminars are a great training resource. Check out the following links:
Excel Spreadsheets: Develop and Validate for 21 CFR Part 11 Comp
liance
Design and Validation of Excel Spreadsheets: Step-by-Step
Learning from Recent FDA Warning Letters Related to Part 11
Understanding and Implementing FDA'S 21 CFR Part 11
How to Comply with 21 CFR Part 11 Requirements for Electronic Me
dical Records
Computerized System Validation - A Detailed Insight
21 CFR Part 11: How to Successfully Prepare for and Host an FDA I
nspection
Complying with 21CFR Part 11-Understanding the Role of Predicate

To know more on 21 CFR 11compliance

visit www.complianceonline.com

Thank You