Solutions for your Need
 In any QA/QC operation, capturing, documenting, reviewing and approval laboratory data takes up a significant part of everyday activities. The SmartLab GMP Electronic Notebook System automates these processes to provide a paperless data management system savings 50-75% on typical cycle times from procedure execution to final approved reports. Each member of you quality team is positively impacted.
Laboratory Analysts – “Freedom from Paper Documentation”
- Current approved methods are delivered “under glass”.
- All instrument data is captured automatically and within the context of the test
method.
- All method calculations are performed in the method and fully validated.
- Results are automatically and securely forwarded to LIMS or ERP systems.
- No more paperwork – the ELN sends the data directly to the report.
Management – “Streamline Cycle Times & Reduce Costs”
- Users report (at IMACS conference) QC lab operation costs reduced by 20%.
- Users report (at IMACS conference) reducing review and reporting cycles by
50%+.
- Major pharmaceutical company reports reducing QC errors from 10-20 per month
to ZERO for “right-first-time” initiative.
- Another major pharmaceutical company reported a 35% increase in workload
(capacity) WITHOUT increasing headcount due to SmartLab automation.
Information Technology – “Connect Fast to IT Systems & Lab Instruments
- SmartLab is a COTS system for fast installation, integration and validation.
- Connects with serial (RS-232) instruments without extra computers.
- Most instrument connections are in the SmartLab Instrument Manager library.
- Integrates with PC-driven instruments, LIMS, ERP, CDS and other corporate IT
systems with a “driver-based” technology and XML-based connections.
- The system validation is optimized with VelQuest provided IOQ documentation.
Compliance + Review – “Simplify Reviews with Paperless Dashboard”
- No more paper data packets, forms or binders to review.
- Electronic access to all lab data, instrument reports and analyst notes at the touch
of a mouse button.
- Review dashboard with “compliance flags” enable review-by-exception for fast
approvals and reduced cycle times.
- Meets all technical requirements for 21 CFR Part 11 including audit trails,
time/date stamping, and electronic signatures.
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