Compliance with government regulations and other standards in a bioanalytical laboratory is critical, yet many labs have not yet taken full advantage of commercial software solutions that enforce compliance while increasing workflow efficiency. Many researchers continue to manually track and account for each experiment as it is planned and executed. In addition, the Quality Assurance teams responsible for compliance must sift through spreadsheets and paper logs to identify any problems with sample analysis runs. Software solutions reduce human error, automate steps to enforce compliance and create efficiencies through effective data management.
Even the most straightforward bioanalytical workflow includes numerous factors that require tracking. The treatment of subjects, collections of samples and analyses of samples must be carefully tracked and verified to prevent deviation from the prescribed method – or, if unavoidable, that such deviation is well-documented. This is a complex and demanding task. At all times, researchers must be able to account for the compound(s) under study, including their identification, preparation and characterization, and prove that the reagents or solutions involved were prepared according to approved methods. All equipment used in the study must be documented and properly maintained. A misstep as small as using a balance that wasn’t calibrated within the last 24 hours can affect regulatory compliance. Finally, data analysis, calculations and results must be verifiable.
This white paper reviews the performance and benefits of PerkinElmer Informatics’ BioAnalytical E-Notebook, a solution that streamlines the bioanalytical workflow, enforces compliance and enables scientists to plan, execute, review and publish their analyses more efficiently.
To read more, Please click on the pdf below.
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