title: Using E-WorkBook Suite to implement quality control in real time: expanding the role of electronic laboratory notebooks within a bioanalysis laboratory.
abstract: In order to support the increasing number of software tools within the bioanalytical (BA) laboratory, electronic laboratory notebooks (ELNs) have to provide more than just paper replacement capabilities. ELN solutions must provide additional functionality to justify deployment in BA laboratories that currently depend on sophisticated instrument software and laboratory information management systems for the capture, analysis and reporting of data. This article reviews how E-WorkBook Suite is positioned to provide functionality not found in other ELN solutions, namely managing workflow execution and tracking quality control compliance in real time. These capabilities are demonstrated by descriptions of a routine BA laboratory process; the registration of a test article, its use in preparing a stock solution and the verification of a balance instrument for weighing the test article. The software solution, in this configuration, guides the analyst through the process and enforces business rules that ensure compliance with specified SOP guidelines. This case study reviews the implementation in a bioanalytical CRO and highlights the use of E-WorkBook Suite in areas that remain unsupported by other software solutions.
authors.affiliation: IDBS, Bridgewater, NJ 08807, USA. jrajarao@IDBS.com
authors.forename: Joe
authors.initials: J
authors.lastname: Rajarao
authors.forename: Scott
authors.initials: S
authors.lastname: Weiss
mesh_terms: D002623:Chemistry Techniques, Analytical / Q000592:standards*; D007753:Laboratories / Q000592:standards*; D011786:Quality Control; D011996:Records; D012984:Software; D013997:Time Factors