AUTOSAVE ALREADY PROVIDES…
AutoSave’s
feature-rich change management and internal security features have long
been beneficial to regulated industry sites as they endeavor to meet
the requirements of the FDA. AutoSave capabilities such as the
following have aided in their 21 CFR 11 compliance efforts:
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• Secured and limited program or feature access
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• Electronic signatures, timestamps of changes
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• Computer generated, permanent audit trails: who, what, when, where, why of changes
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• Record and file retention in secured server
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• Automatic notification of changes
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• Scheduled change discovery
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• Library management with real-time archiving
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• Broadest range of supported architectures, devices, and editor software applications
ADDITIONAL APPROVAL AND WORKFLOW FEATURES…
ELECTRONIC APPROVALS
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• Configure approval groups of users
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• Establish lists of required approval groups for specific programs
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• Automatic e-mail sent to approvers when a program is ready for the process
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• Each approval electronically entered with comments and work authorization number
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• Electronic entry of an approval rejection with comments during any status resulting in immediate demotion of the revision’s status
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• Electronic maintenance of approval status and full history
MULTIPLE REVIEW STATUSES
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• Signify program versions that are in different statuses: Request for Approval, Test, Validate, Implement
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• Allow only its ‘Implemented’ version be downloaded to a production processor
VERIFY & CONFIRM PROCESSES
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• Access to key functions requires user to re-enter password, thereby verifying individual is the logged in user
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• Critical
functions require verification process, then electronic confirmation by
an approver proving individual is the logged in user
NEW SECURITY FEATURES
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• Control of expiring passwords and prior password re-use
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• Capture e-mail addresses for AutoSave users for approval and other notifications
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• New default classes for approvals, approval administration
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• New privileges for the various approval process steps
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• Augment existing automatic logs with additional, electronic log messages
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• Configure required approval processes
NEW FUNCTIONS & FEATURES
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• Regulated
Industry feature set is licensed separately and can be enabled with any
AutoSave plug-in module for a particular device/editor application
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• Enhanced logging added to AutoSave’s already substantial tracking/audit trails; include logging of admin functions as well
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• Configure approval groups and lists of groups applicable to entire directory or customize at program level
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• E-mail notification of approval process events
LIFECYCLE OF A CHANGE
1. Create new version; automatic status to Edit
2. Off-line edits performed, saved, completed
3. Request approval to download; automatic status to Request For Approval
4. Status change triggers e-mails to all potential approvers in configured groups
5. Approvers determine whether or not to approve
If approve...
- Approver accesses Add Approval menu
- Verify & confirm processes performed
- Add Approval dialog completed
- Approval record stored; e-mail sent
- Approval process repeated by each group
- Partial approvals tracked, color coded
If Reject...
- Approver accesses Reject menu
- Verify & confirm processes performed
- Add Reject dialog completed
- Reject record stored, e-mail sent
- Automatic status change = Edit
- Change life cycle starts over
6. All approvals added; automatic status change to Approved Pending Validation
7. APV version downloaded to quarantined processor, status to Test (verify/confirm)
8. Validation testing, documentation, sign-offs performed
9. Manual change status to Validated
10. Manual change status to Implemented, put into production; previous Implemented version automatically demoted to Previously Approved
