A pharmaceutical LIMS keeps the sample against the batch it came from, which is what makes pharma LIMS different from a testing lab's: the result belongs to a lot of product, the signature on it is an electronic record under Part 11, and the QC batch that ran beside it is evidence. LIMS pharma use at a small site is the same record as a large one at a scale one QC manager runs, and LIMS pharmaceutical requirements come down to the batch link, the signature, the audit trail and the export. What is LIMS in pharma, asked by a small site, is answered by those four. This page is about them, and the free quality control sheet on this site works the QC share and spend from the site's own numbers with no account.
LIMS pharma requirements: the batch link
Every sample carries the product, the batch and the stage it was pulled at; every result inherits them, so the certificate of analysis for a batch is a lookup. A LIMS in pharma that keeps the batch as a text field rather than a record cannot produce the certificate without a spreadsheet.
The signature and the audit trail
Part 11 describes what an electronic record and an electronic signature must keep for FDA-regulated work: who signed, when, what it meant, and every change since with who and when. A pharmaceutical LIMS keeps that on every result; a small site's quality manager reads the rule, and this site restates none of it.
QC as a record in a pharma LIMS
Control samples per batch, their limits and the out-of-control events are the QC record a pharma LIMS keeps against every run. The quality control sheet on this site works the QC share and spend, 75 QC samples a week, 25% of reportable tests and $4,550 a month on the worked example, and Limslane Pro keeps the QC samples against the batches they ran with.
Questions people ask about pharmaceutical lims
What is LIMS in pharma?
The sample record with the batch attached, an electronic signature on every result, an audit trail and an export; the QC batch kept as evidence beside each run.
What makes a pharmaceutical LIMS different?
The batch link and the Part 11 record: the result belongs to a lot of product and the signature is an electronic record. The free QC sheet works the QC figures either way.
Does a small pharma site need an enterprise LIMS?
It needs the four requirements; whether it needs an enterprise product to get them depends on the site. Limslane Pro keeps the record at one flat price.