SmartLab™ Data Review Dashboard
In today's paper-based systems, the analyst prints a hard copy of the current version of the analytical procedure, collects his/her lab notebook or control sheets and begins manual entry of test data and huge amounts of supporting metadata.
The SmartLab-enabled analyst, by comparison, picks up his/her electronic clipboard, securely logs in to begin a laboratory session, and automatically receives the assigned tasks and procedures from their electronic notebook.
 Data Capture
The electronic clipboard displays each step in the procedure or the electronic control sheet view and automatically prompts the analyst for any required metadata and test data.
Using wireless technology, the electronic clipboard can also trigger the SmartLab server to request any needed test data from network instruments, securely (21 CFR Part 11-compliant) stores the records and then displays data back to the analyst. Procedures may also call for selected data to be forwarded to other instruments or applications within the laboratory IT infrastructure; with the SmartLab system, this is a simple, one-click operation.
 Audit Trail
During data capture, if a result should fall outside of a pre-set window, an automatic real time alert is generated, requiring specific action on the part of the operator. In compliance with 21 CFR Part 11, any changes to data must be documented within the context of a defensible authenticity, authority and audit trail.
Data Review
VelQuest's At-a-Glance™ Data Review provides a summary of completed or in-process procedures. Any authorized person from any terminal on the network can access this summary. Data Review lists each step in the procedure that acquired data, and summarizes all the data and its related metadata in a “dashboard” view.
Only exceptions need to be reviewed, not every single step. All necessary data is in one place, with ambiguous or "out-of-spec" results clearly indicated and linked to supporting information.
 "Compliance Flags"
The columns on the left of the dashboard screen are called "Compliance Flags." A validated system only requires manual review of out-of-specification or unexpected data; the Compliance Flags let you see "at a glance" any data entries that may need attention.
The Review Compliance Flags include:
- AT (Audit Trail) Indicates that there were approved changes to the displayed data. By clicking on the flag, the reviewer can observe all changes with their approved reasons.
- OL (Out of Limit) Indicates that the displayed data is outside a preset limit - but was accepted for use. The reviewer will likely review the approved reason.
- OD (Out of Date) Indicates that a calculation contains data that was subsequently changed; analysts use this flag to remind them to recalculate.
- SD (Supporting Data) Indicates there is backup information for the data used in the SmartLab procedure. This is analogous to printing a full report from a PC-based instrument and pasting the printed copy in a lab notebook.
- An (Annotation) Allows the analyst to enter free text comments to clarify any event or ambiguity which might help interpret the data.
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