Traceability in OneLab: Tracking the Analyst’s Completion of an Experiment
Bringing increased confidence to sample preparation workflows using automation, smart laboratory tools and electronic documentation for recording analyst activities
Laboratory employees appreciate the importance of traceability in their analytical work, whether to simply check for quality, or for regulatory reasons. Electronic documentation of laboratory activities can ensure consistency, accuracy, legibility and availability of experimental records, however, manual entry in an electronic document is as onerous as writing in a paper notebook. By automating the documentation as much as possible and removing the burden from manual traceability processes, records are more accurate, more complete and less prone to errors.
OneLab software from Andrew Alliance provides traceability for the analysts’ activities, making it simple for reviewers to have confidence that experiments were executed consistently as outlined in the standing operating procedure (SOP).
OneLab is compliant -ready because it includes the technical controls mandated by pharmaceutical and non-pharmaceutical laboratory requirements, such as electronic record and electronic signature (ERES) regulations (e.g. ISO 17025, EU Annex 11 or 21 CFR Part 11). When these technical controls are combined with procedural and administrative controls, including computer validation / assurance evaluations, OneLab can be used in GLP, GCP and GMP laboratories.
OneLab includes three user roles with a hierarchy of privileges. Each of these roles (Operator, Member and Administrator) and how they contribute to lab traceability will be explored in this blog series.
Once a defined experimental protocol is available, any analyst logged in as an Operator or Member and with access to the designated lab workspace where data are shared, can follow this protocol to perform laboratory experiments. The Operator role cannot modify a protocol at all, so there is additional assurance that it will be followed precisely.
For a fully automated experiment in OneLab, the analyst will prepare the correct devices, tools and reagents required. Once the protocol is designed, the instrument is set up, and the samples are ready, the Andrew+ robot can automatically execute the protocol.
For a manual protocol, the analyst will still prepare the equipment and solutions, and will then follow the protocol execution instructions step by step, as instructed. As each step is performed, clear text and graphical instructions will guide the analyst, and critical information will be recorded for the duration of the protocol.
All analyst (or robot) actions are recorded in the experiment, in an audit trail/experiment log, with an indication of elapsed time from the start of the experiment. Responding rapidly to customer feedback, the newest release of OneLab has been enhanced to record accurate timestamps and information about the duration of each specific step. This can be a useful traceability tool to determine if a step was performed accurately and correctly in an appropriate or expected amount of time.
OneLab can even cope with errors and mistakes, because no experiment completes perfectly each time. If an automated step on the Andrew+ robot has an error (such as ’tip cannot be inserted’ or ‘collision with an obstacle’), it will always be recorded in OneLab. If an analyst makes a mistake, such as ‘wrong volume dispensed,’ the analyst can document the error with an explanation, and then document a remediation step, if that is allowed in the protocol. The experiment can then continue, or alternatively, the protocol may force the analyst to restart the step or the entire experiment. This will all be readable and traceable by the reviewer of the experiment.
An analyst might not be able to complete an experiment in one session. Upon login, OneLab allows an analyst to view all their own experiments that are in process and those that were recently completed.
The traceability provided by OneLab allows a laboratory manager to view all work completed or in progress, across their entire lab, through the OneLab Lab Workspace. Managers can also be confident that every experiment will have the traceability to all device and tool logbooks used in the task.
When automation is employed to improve quality and integrity of data, two approaches can be taken:
- Automate as much as possible, so that a process or experiment can be validated one time, ensuring confidence that it will be completed the same way each time it is executed. This is the path to true “review by exception” where only experiments or activities where a failure, deviation or exception is flagged need to be reviewed.
- Guide the analyst through the procedure, ensuring that they can only operate within the defined parameters of the process, and document, as automatically as possible, all the analyst actions, thereby simplifying the second person review process.
With OneLab, both approaches are possible; either guide a logged-in analyst through manual steps, following a predesigned protocol, prompting them to document actions contemporaneously and automatically track any equipment or device that is used in the experiment, or, utilize the Andrew+ robot to execute the protocol, while still documenting every step.