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File/Document Based Systems |
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Background |
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Examples of Files/documents that are subject to 21 CFR Part 11 are: |
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Laboratory raw data files from instruments |
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PLC/SCADA history or configuration files |
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AutoCAD drawings storing equipment/system specifications |
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MS Word files storing SOPs, specifications, or validation documents. |
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Selected 21 CFR Part 11 Issues Related to Files/Documents |
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Security:
Files are stored on
local hard drives or
network servers, and
maybe easily
accessible to
unauthorized
individuals. Files may
be modified, copied or
deleted by
unauthorized personnel
with no record of
these events. |
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Lack
of Audit Trail:
There is no audit
trail of changes made
to the file, even when
made by authorized
personnel. |
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Lack
of Version Control:
There is no version
control of such files.
Any changes made to
the file obscures the
previous version of
the file. |
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Lack
of Electronic
Signatures:
There is no provision
for electronic
signatures. |
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Data
is stored in a single
flat file which can be
subject to accidental
erasure or corruption. |
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The eInfotree Solution |
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File
Vault: Store your files in the Oracle-based database vault. |
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Check-In/Check-Out: Files must be checked out in order to make changes to the file, and then checked-back in after changes are complete. |
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Version
Control: Full version control is provided, with all versions of a file stored in the eInfotree File Vault. |
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Audit
trail: All events are logged to the audit trail database. |
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Configurable Electronic
Signatures: File events can be configured to require an electronic signature. |
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Security: Access to files can be restricted to authorized personnel. Unlimited number of security levels can be established and applied. |
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Files can be accessed globally using a web-based browser interface. |
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Use of a more robust and reliable database platform |
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Password Management |
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Password Aging |
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© Copyright
2000-2008. CIMCON Software, Inc. All rights reserved. |
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