Laboratory information management systems compared: what is laboratory information management system scope, and how laboratory information management software and laboratory information management system software differ

What the system is expected to own

1. Sample registration and chain of custody. Every sample enters once, with its source, its container, its condition on receipt and its storage location, and every subsequent movement is recorded against a person and a time. This is the part an auditor will test first and the part that is most painful to retrofit.
2. Test assignment against a method. A sample is assigned tests, each bound to a version of a method with its own specification limits and its own trained-analyst list. When a method is revised, the system has to keep old results tied to the version they were produced under rather than silently re-pointing them.
3. Result capture and review. Results arrive by instrument interface or by keyed entry, are checked against specification, and pass through a review step that a second person performs. Systems differ sharply in how much of this they enforce and how much they merely record.
4. Reporting and release. The certificate of analysis, the trend report and the export to whatever the customer or the regulator expects are produced from the same record, with the release decision recorded against a named person. A system that produces reports by exporting to a spreadsheet has moved the record out of itself.

Where the software boundary falls

A laboratory information management software package normally stops where the instrument's own data system begins. Chromatography data systems, mass spectrometry software and plate reader packages keep their own raw files and their own processing audit trail, and the system of record takes the reported result plus a pointer back. Vendors that promise to absorb the instrument data system entirely are describing a much larger project than the one being quoted.

The other boundary is the electronic lab notebook. A laboratory information management system software quote that includes notebook functionality is usually offering a light version of it, which is fine for a lab that writes little narrative and inadequate for one that writes a lot.

Making two quotes comparable

Write your own scope before you ask for a price: the number of named users, the number of concurrent users, the instrument list with makes and models, the workflows by name, the reports you must produce, and whether the environment is regulated. Send the same document to every vendor and ask each to price against it line by line.

Quotes that arrive in the vendor's own shape are not comparable and are not meant to be. Insisting on your own shape costs an afternoon and is the single most useful thing a buyer in this category can do.

Common questions

Is a laboratory information management system the same as LIMS?

Yes. LIMS is simply the initialism, and vendors use the two interchangeably in their own material. The long form is more common in tenders and in regulatory documents.

Can a laboratory information management system replace our spreadsheets?

For sample tracking, result capture and reporting, yes, and that is the point of buying one. Spreadsheets usually survive for method development and for one-off analyses, which is reasonable as long as nothing released to a customer depends on them.

Does the system need to be validated?

If your results support a regulated submission or a regulated product, the installed configuration needs qualifying and the qualification needs maintaining through upgrades. A research lab with no regulatory exposure can take a much lighter approach, but should still record what it configured and why.

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