As a laboratory, you’re generating data, day in and day out. This data is used to make critical product decisions, and therefore, it’s important that the laboratory produces accurate and reliable test results. Each time the same product is tested, results are always compared to the product specification; However, trending results against historical data provides you with a leading indicator of production’s performance. For example, if the data shows results have been slowly decreasing over time, then this may lead to low out of specification results if the trend continues in future batches. Trending data allows you to spot patterns, predict and address potential issues which can help prevent manufacture of non-compliant product.
How to Implement Continuous Data Trending
Data review is a critical part of the quality control process. A GMP laboratory requires a second person to conduct an independent data review for accuracy, completeness and compliance to established standards. Continuous data trending should form part of this review and having the right tools in place can help you trend data efficiently. Tools that you could use are:
- Spreadsheets – Spreadsheets are an easy-to-use, customisable tool that is readily available. They are easy to populate, sort and filter data; however, they lack auditing functionality for tracking changes. GMP laboratories need to validate spreadsheets which are used to store, manage or analyse GxP data. This is to ensure that data integrity is maintained and access for editing is controlled.
- Laboratory Information Management Systems (LIMS) – LIMS is a useful tool designed for laboratories to store and manage data in a consistent and compliant manner. Most LIMS systems will have built-in reports or reporting tools to allow you to generate a trend report for a specific test and product with a click of a button. In addition, LIMS systems typically have sophisticated audit trails so you can be assured that data integrity is maintained. Trending data via LIMS is more efficient than spreadsheets because LIMS uses data entered by the analyst where as spreadsheets will require transcription from a workbook or another system to populate the data for the trend chart or report.
- Enterprise Resource Planning (ERP) Systems – ERP systems are generally used by manufacturing facilities to organise data from point of sale to distribution. Most ERP systems provide a Quality Module whereby test results can be populated and a batch disposition decision can be recorded. In addition, most ERP systems will have a reporting package that can be used to query the database and create validated reports that displays trend charts. It is, however, stereotypical that ERP systems only provide minimal functionality for quality control laboratories, but you should still have the functionality to compliantly trend test results.