Traceability in OneLab: Protocols Designed by the Expert Analyst

By August 11, 2020

Typically, expert staff in a lab will be responsible, along with Quality Assurance, to design and document a standard operating procedure (SOP) for other analysts to follow for routine sample preparation tasks. These procedures are key for repeatability and accuracy of laboratory experiments; therefore, SOPs are important laboratory documents, which need to be issued and revised in a controlled manner, with review and approval before useAll staff are trained on SOPs, as these form the pillars of laboratory quality. Analysts are then expected to follow the steps exactly, and document, traditionally in lab notebooks or paper worksheets, that the process was adhered to. 

With compliant-ready OneLab, a cloud-native software, user privileges, folders and devices are configured by the administrator, and then an expert user, with the role Member, can securely log in and design a new protocol for analysts to follow. This protocol will be available to all analysts in a designated OneLab Lab Workspace, regardless of their OneLab user role.

A protocol can be designed entirely for manual execution, guided pipetting with Pipette+, or it can be designed to be executed automatically by the Andrew + pipetting robot, with very little assistance from the analyst. 

The same protocol can be executed manually, guided by smart-connected Pipette+ or fully automated with Andrew+

For the highest levels of traceability, the more detailed the protocol, the better. For automated execution using the Andrew+ robot, detail is critical, and appropriate validation testing would be required before releasing this protocol for general use.

Protocols can include detailed instructions for the analyst

However, when executing the protocol with guided pipetting using the Pipette+ toolset, precise details are also useful to ensure that analystcan execute protocols with few errors. Protocols can define not only the steps that the analysts need to follow,  but can also include informative text to tell the  analyst how to set up the experiment and exactly which devices or tools should be used, including  model number and even serial number of the device, if required.  A protocol can also include instructions to verify calibration dates to prevent the use of non calibrated equipment.

The Member role prepares a material list, which includes labware and reagents

An expert user might also preconfigure a suite of reagents, including critical meta data about the reagent (composition, who it was prepared by, preparation date, expiration date, etc.) as well as the labware and devices to be used. By specifying those reagents in a protocol, there will be a higher degree of confidence that analysts do not make mistakes, in either documenting the details or using the wrong reagents.

A protocol will normally be designed to prompt the analyst to document certain actions or critical values. In regulated laboratories, contemporaneous documentation is key for data integrity and compliance, but in any laboratory, it is much easier and with less chance of errorwhen users can make notes as they perform activities rather than rely on their memory when they get back to their desks. 

As with an automated protocol with the Andrew+ robot, protocols based on analysts using guided or manual pipettingshould also be verified before being released for use. This will typically involve some level of documented testing to be sure that the protocol includes all the steps required for the experiment before it is approved for use in the laboratory. 

Programming the Andrew+ robot or guiding an analyst through a validated protocol with assisted automation, will not only increase throughput and repeatability in a laboratory, but will create very detailed and automated documentation of steps taken by analysts. That documentation simplifies the role of the lab supervisor or reviewer, who relies on this traceability to review the completeness and quality of the experiment. 

Are you wondering how easy this is to set up? Does it take a long time to configure? See “OneLab Configuration by the Lab Administrator” which describes both use and device configuration. 

Related Resources: 

Categories: Automation