SmartShell™ Part 11 Remediation Solution
Comprehensive Solution for Part 11 Remediation of Legacy Systems
VelQuest's SmartShell Part 11 Technical Remediation Solution comprehensively addresses 21CFR Part 11 requirements, and gives legacy PC based systems and software (ex. Excel, JMP etc.) the functionality to remediate non-compliant applications and instruments.
With the SmartShell solution, virtually any type of PC-based system or software application can be brought into compliance, without having to replace or upgrade costly hardware and without time-consuming revalidation and additional operator training. The easy-to-implement software/storage solution also eliminates the need to coordinate multiple vendors and their various interpretations of Part 11 guidelines.
How the SmartShell system works
As the name implies, the SmartShell program basically "wraps" an individual local PC, enforcing identification and eligibility requirements. The SmartShell program controls access to all applications in strict conformance with Part 11 criteria. It monitors and controls all manual and automated disk operations and redirects file traffic to a secure 21 CFR Part 11 repository, and provides a clear, defensible audit trail for all activities. Existing and advanced security measures, such as token devices and proximity detection, may also be used.
The SmartShell program redirects all disk commands to a Part 11 compliant repository. For long term storage, files can be forwarded to an external Part 11-compliant archival repository.
SmartShell for Process Analytical Technology (PAT) Instruments
Today, many instruments for PAT are being deployed from non-life science instrument vendors. Typical process mass spectrometers, raman spectroscopy, NIR and FTIR instruments lack the high level of 21 CFR Part 11 technical requirments for use in a cGMP environment. SmartShell can remediate those instruments quickly and at a fraction of the cost of the instrument vendor's developement projects. VelQuest is actively involved in pharma and biotech companies that are now working on PAT initiatives in their production plants. Call us for more details.
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