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11.10(a) |
Validation
of systems to ensure
accuracy, reliability,
consistent intended
performance, and
the ability to discern
invalid or altered records. |
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The
eInfotree Excel Module has
been developed following FDA
recommended software
development practices and
procedures. A validation
package can be provided with
the system that includes
Software Functional
Requirements, and
Installation, Operational
and Performance
Qualification protocols.
Record changes, including
any invalid or altered
records, are recorded in a
secure, computer-generated
audit trail. Refer to
Section 11.10(e) for more
details on audit trail.
|
As
with any Computer-Related
System, client shall carry
out end-user validation of
the system as implemented
and configured onsite. CSI
can provide validation
documents and services to
reduce the time and cost
involved with validation and
for speedy implementation |
|
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 the
agency. Persons should
contact the agency if there
are any questions regarding
the ability of the agency to
perform such review and
copying of the electronic
records.
|
|
Audit
trail records are stored in
Microsoft Excel in a human
readable and electronic form
suitable for inspection,
review and copying by the
agency. |
|
|
11.10(c) |
Protection
of records to enable their
accurate and ready retrieval
throughout the records
retention period.
|
|
Records
are stored in Excel for an
indefinite period of time. |
Client
shall implement backup and
archiving procedures to
protect Excel files
throughout the records
retention period. |
