34th SQA Annual Meeting and Quality College

C-1 The Case of the Failing Pipette – A Case Study of Auditing in an Electronic Bioanalytical Laboratory

Abstract:
A common problem that every laboratory faces is when a pipette fails to meet the acceptance criteria during a re-calibration activity. The first question every auditor wants to know is:
“What studies were impacted by using this pipette?”
As an auditor, you are left reviewing laboratory notebooks. Was the pipette used by only one analyst? Which laboratory area utilized this pipette? The lingering question remains:
“Did we find and document every study where this pipette was used?”
By using an electronic laboratory notebook to document every step in the workflow, from sample receipt through to final reporting, this pipette in question can be queried in minutes.
While auditing, a query can be ran to search any data held electronically within the electronic laboratory notebook (ELN). Queries can be as broad or as specific as the end user needs. This search would find in minutes what would normally take days or may even be impossible to locate. Audit trails can also be utilized to review the data and date/time the pipette was used. A thorough audit to determine where this pipette was used can be completed in just a few minutes.
Screenshots will be presented on the poster to show a query to search for the pipette used.

Category:
Bioanalytical

Level of Content:
Intermediate

C-2   Data Governance Best Practices for Bio-analytical Labs/studies

Abstract:
Bioanalytical sites performing regulated activities must incorporate key data integrity elements into their systems to ensure that all data are complete, consistent, and accurate throughout the data lifecycle. This presentation will focus on electronic data acquisition systems used for regulated bioanalysis. An overview of the configuration, validation, and maintenance of representative electronic data systems will be presented.  An audit program that includes provisions to evaluate the elements of the quality system used for collecting, analyzing, reporting and retaining information and bioanalytical data will be addressed. This presentation will provide Quality Assurance professionals involved in auditing bioanalytical data with insights to help assure electronic data integrity.

Category:
IT Compliance

Level of Content:
Advanced