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21 CFR Part 11 sets forth the FDA's standard for electronic signatures and tracking
of all changes to your database. Companies that wish to have electronic records
and electronic signatures accepted as equivalent to the corresponding paper records
must comply with this standard.
GAGEtrak's electronic security features make implementing 21 CFR Part 11 in your
workplace simple, straightforward, and secure.
With our commitment to compliance assurance,
it's no wonder that over 10,000
organizations worldwide use our software
applications in virtually every type of
industry and organization.
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Assured Compliance for Your Company |
To better assure our customers of compliance with 21 CFR Part 11, CyberMetrics voluntarily
undergoes independent 3rd party audit, review and certification. This
includes actual on-site inspection of our records, product development practices,
testing methods, maintenance procedure as well as specific functional assessment
of our software.
Copies of our compliance certification letters are available upon request.
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Security |
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When you install GAGEtrak you are prompted to choose to implement 21 CFR Part 11.
The 21 CFR Part 11-compliant version requires security to be active at all times,
so from the beginning you must set up users and groups and define their security
privileges.
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With security active, you can also control which users have access to what forms
and even what parts of forms. To make security easier to implement, you can create
groups with standardized access privileges and assign users to one or more groups
as needed.
If you are installing the standard GAGEtrak, security is not required, but you may
set up security if you wish. GAGEtrak's 21 CFR Part 11 features such as electronic
signatures and audit trail work only when security is active.
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Electronic Signatures and Approvals |
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The 21 CFR Part 11-compliant version of GAGEtrak requires signatures and
approval signatures when checklists, work orders, and service requests are completed,
and when purchase orders are issued.
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Once a record has been signed, it cannot be modified unless the original
signer unsigns it; once an approval signature is recorded, the signer of the approval
must unsign it before the signer can unsign it.
GAGEtrak maintains a comprehensive history of all signatures on a given record,
including date, time, and signer. If the record has been unsigned, that information
is recorded as well.
If you wish, for added security, you may require users to log in and enter
a password whenever they sign or approve a record. 21 CFR Part 11 installations
must log in each time a record is signed, approved, unsigned, or unapproved.
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Audit Trail |
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The 21 CFR Part 11-compliant version of GAGEtrak automatically enables the
Audit Trail, which maintains a comprehensive history of all user actions such as
record modifications, additions, or deletions, and the user who performed them.
This record is preserved indefinitely. Non-21 CFR Part 11 users may have GAGEtrak
purge these records after a set number of days have elapsed.
The Audit Log can be viewed onscreen or printed out; if you want to see only
certain records, you can search for those records using GAGEtrak's easy-to-use report
filters.
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