{"id":4808,"date":"2020-08-14T20:10:00","date_gmt":"2020-08-14T20:10:00","guid":{"rendered":"https:\/\/www.waters.com\/blog\/traceability-in-onelab-onelab-configuration-by-the-lab-administrator\/"},"modified":"2023-10-06T20:39:13","modified_gmt":"2023-10-06T20:39:13","slug":"traceability-in-onelab-onelab-configuration-by-the-lab-administrator","status":"publish","type":"post","link":"https:\/\/www.waters.com\/blog\/traceability-in-onelab-onelab-configuration-by-the-lab-administrator\/","title":{"rendered":"Traceability in OneLab: OneLab configuration by the Lab Administrator"},"content":{"rendered":"\n

Bringing increased confidence to sample preparation workflows using automation, smart laboratory tools and electronic documentation for recording analyst activities<\/span><\/span><\/h4>\n\n\n\n

This article was revised in September 2023 to include important updates.<\/em><\/strong><\/p>\n\n\n\n

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 requiring only setting up and validation of the automated calculations. 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 tracing the \u201cstory\u201d of the steps taken by the analyst for review purposes and to ensure accurate lab work is a big challenge for a lab supervisor.<\/p>\n\n\n\n

When electronic documentation is leveraged, these tasks can be simplified for both the analyst and the reviewer while providing higher confidence in proper SOP execution. Technical controls such as time stamps, attributable analysts\u2019 identification, equipment calibration checks, and detailed use logs can all be made available to document and track actual laboratory practices.<\/p>\n\n\n

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Figure 1. Exact timestamps for actions and experiment duration are captured in OneLab<\/figcaption><\/figure>\n<\/div>\n\n\n

These technical controls are critically important at the \u2018entire system\u2019 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, to meet the ALCOA+ definitions of data integrity.<\/p>\n\n\n\n

Deploying any software tool designed to trace the actions of laboratory analysts performing experiments first needs some level of configuration: who are the analysts, what actions are they allowed to do, and which instruments or devices will they need to use. Traditionally, just capturing and keeping up to date information about instrument inventories can be a time-consuming activity. In addition, GxP regulations for Data Integrity concepts like \u2018attributability\u2019 need to be considered.<\/p>\n\n\n