EtQ FDA
Compliance Management Software
System is a flexible
software package that guides
companies through compliance
with cGxP,
ISO 13485,
21 CFR Part 11, ISO
9000, and similar standards
for FDA Compliance.
Electronic Signature Binding
EtQ FDA
Compliance Management Software
System automatically
and securely binds the authenticated
user's electronic signature.
EtQ ensures that the user
has signed onto the system
and exposed their signature
via the forced authentication
process. Authentication
is required each time a
document is processed.
Audit
Trail
EtQ securely and automatically
posts any and all field
changes to a separate database.
The Audit Trail includes
the field's old value, new
value, name of user who
made the change and date
and time.
Controlled/Secure
Access
EtQ's robust security model
ensures that your
FDA Compliance Management
Software System and
data have the highest security.
Information access is controlled
by a username, id, password,
form, form section, field
and workflow.
FDA
Compliance Package
Comprehensive validation
documentation is an integral
part of the EtQ
Implementation process.
Enhanced
Password Security
Automatic password aging
with configurable expiration
and warning periods, as
well as automatic protection
against repeated attempts
to log in without proper
username and password.
Enhanced
Audit Trail Field
Enhanced Audit Trail feature
allows users to "mouse
over" EtQ fields, displaying
the Audit Trail for that
particular field.
| FDA
Compliance Validation |
| • |
Validated
21 CFR Part
11 compliance
with largest
customers in
the industry |
| • |
Single
interface for
all applications
and administration
- no need to
validate client
at all |
|
|
| FDA
Compliance Audit Trail |
| • |
Display
the Audit Trail
for a specific
field, a specific
event (phase)
or for the entire
record |
| • |
Audit
Trail can be
enabled for
specific phases
or specific
fields |
| • |
Audit
Trail can be
saved as MS
Excel Spreadsheet |
| • |
Audit
Trail includes
user name and
id, date and
time, record
phase (reason
for change),
old data, new
data, and comments |
| • |
Configuration
Management:
Ability to track
changes made
to configuration
settings within
the application
in the Audit
Trail |
| • |
Track
changes to user
accounts (i.e.
update, enable,
disable) in
the Audit Trail |
| • |
Track
changes to field
values in the
Audit Trail |
|
|
| FDA
Compliance Security
& Electronic Signatures |
| • |
Electronic
Signatures and
Records: displays
the user name
(Signer), ID,
Record Phase,
Activity and/or
Event, and meaning
of the signature |
| • |
Secure
access using
SSL encryption |
| • |
Electronic
Signature consists
of user name,
date and time,
time zone, and
meaning of the
signature (i.e.
record phase,
name of activity,
etc) |
| • |
Supports
different time
zones by using
GMT offset -
uses Global
date formatting
(International
Data Format
- GMT) |
| • |
User
name and password
is used to verify
Electronic Signature |
| • |
Authentication
required to
access any part
of the system |
| • |
Closed
system |
| • |
Administrator
access level
can be defined
to set up security
|
| • |
Configurable
password expiration
dates (expire
password after
X number of
days) |
| • |
Require
users to change
passwords when
they log in
for the first
time |
|
|
| FDA
Compliance Workflow |
| • |
Activities
can be restricted
to the designated
person responsible |
| • |
Allow
access to all
records until
they are no
longer needed |
| • |
Records
can be displayed
on screen, in
reports, electronically,
or exported
into a flat
file format |
| • |
Create
workflow
configurations
to enforce record
routing |
| • |
Make
specific events
require a comment
(i.e. must provide
a comment for
all rejected,
archived, restored
actions) |
| • |
Send
records with
different access
control rules
to separate
archives for
purging or classification |
| • |
Keeps
a record of
every version
of an attachment
when it is modified |
| • |
Automatically
promote configuration
changes between
environments
(e.g., from
Development
to Test to Production) |
|
|
EtQ's
FDA Compliance Software
System
|
