Method Validation in a LIMS and CDS Centric Lab Environment

This talk will focus on doing method validation work in an environment where data is gathered from laboratory information systems and chromatography data systems. We’ll see how these systems can be connected, their data used and refined with additional calculations to be the foundation of method validation work.

Depending on the type of data and the underlying method validation requirements such projects can be demanding, both in terms of data handling efforts and compliance. Projects can be huge (wastewater, environmental analysis, trace analysis) with high data volumes to be transferred, additional calculations might be necessary to prepare the data for our method validation calculations. All calculations must be either available as standard or be simply defined on a per-project basis.

The resulting reports must contain both detailed results as well as automatically created summaries – zero-effort reporting. If necessary, additional material such as documents and images need to merge with the final document. Whatever information will be generated, it must be usable as printout or document export and available as input-feeds for external systems in well-defined formats (database, XML, JSON). All that must be simple in use and powerful in compliance – workflows, audit trails and revision history is mandatory.

Learning Objectives:

1. Discuss how to connect your LIMS and CDS systems and transfer your data effortlessly.

2. Review your calculations and get a detailed report with automatic summaries.

3. Summarize how to ensure compliance by managing audit trails, revision history and signatures.