Traceability in OneLab: OneLab configuration by the Lab Administrator
Bringing increased confidence to sample preparation workflows using automation, smart laboratory tools and electronic documentation for recording analyst activities
Consistency, accuracy, compliance and data integrity can each be improved with automation of laboratory processes. We know that automated systems can not only reduce human errors when performing calculations but can also make documentation and traceability of result creation a simple process of setting up and then validating the automated calculations.
In the same way, traceability and accountability for sample preparation is achieved today with manual documentation activities, in paper lab books and instrument logbooks. Not only are these tasks tedious for the analyst and prone to errors, but for a lab supervisor, following the sequence of events for review purposes, piecing together and tracing the story of the steps taken by the analyst to ensure accurate lab work, is a big challenge.
These tasks can be simplified, for both the analyst and the reviewer, and yet provide higher confidence in proper SOP execution, when electronic documentation is leveraged. Technical controls such as time stamps, attributable analysts’ identification, equipment calibration checks and detailed use logs can all be made available to document and track actual laboratory practices.
These technical controls are critically important at the ‘entire system’ level that is governed by the designated Laboratory Administrator in OneLab. It may be part of their job to document, and demonstrate to internal and external auditors, that technical controls required by electronic record and electronic signature (ERES) regulations (such as 21 CFR Part 11, EU Annex 11 and ISO 17025) are implemented. It is also important that procedural and administrative controls are in place to ensure user actions are controlled and recorded, and that data are secure, so as to meet the ALCOA+ definitions of data integrity.
Deploying any software tool designed to trace the actions of laboratory analysts performing experiments needs first some level of configuration: who are the analysts, what actions are they are allowed to do, and which instruments or devices will they need to use. Just capturing and keeping up to date information about instrument inventories traditionally can be a time-consuming activity. In addition, GxP regulations for Data Integrity concepts like ‘attributability’ need to be considered.
The OneLab user roles are very intuitive. While the Administrator role can create users and data folders, and a Member role can create or modify experiment protocols, the Operator can only follow a predefined protocol, which provides guidance in the correct use of the software and the laboratory instruments. Users of Andrew Alliance’s OneLab, even at the Administrator role, can never delete data or records, which makes meeting regulatory requirements of “completeness” easy.
Teams of OneLab users can be assigned to specific “Lab Workspaces”, allowing them to share devices, tools, protocols and experimental details. This also manages the visibility to other user’s experimental work.
Maintaining accurate instrument logbooks is a big challenge for most laboratory staff. Even with electronic solutions, entering information about serial numbers, firmware versions and calibration cycles can be tiresome at system set-up, but keeping it current and accurate is a chore that is easily overlooked. With smart connected tools and devices, much of this critical meta data can be captured automatically in OneLab. Users can be instructed to check the last calibrated date of a device, BEFORE using it, saving time in having to repeat work that deviates from the protocol.
Additional information, such as capturing vendor maintenance or calibration tasks, daily “suitability checks” can also be recorded in OneLab. Altogether, this documentation is used to ensure that the instrument or tool is performing properly before it is used for any lab work.
Once the instrument inventory is set up, the lab experts and analysts can go to work, with confidence that any records they create are created “contemporaneously” and that specific actions and records are “legible” for the reviewer. Because OneLab software traces the use of each instrument or tool, instrument logbook histories are created automatically in the device management interface, without the need to manually document their use. Electronic logs capture details of each experiment the instrument was used for, by which laboratory analyst and records any issues. In addition, a detailed technical log for each connected tool is saved, which can be exported to assist in troubleshooting.
Andrew Alliance’s compliant-ready OneLab, along with smart connected tools, makes configuration and set-up simple and foolproof. The user configuration is straightforward and allows the software to trace each analysts’ actions as the software is used. The instruments generate their own logbooks automatically based on the analysts’ use, without the need to manually write everything in an error prone paper or electronic record.
- Traceability in OneLab: Protocols Designed by the Expert Analyst
- Traceability in OneLab: Tracking the Analyst’s Completion of an Experiment
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