A laboratory information management system (LIMS) is the software that runs a laboratory's work: it logs each sample, assigns each test, records each result and keeps the records that inspectors will check. In a drug maker's quality-control laboratory, the LIMS decides, test by test, whether each batch of medicine meets its standard. It is the laboratory's system of record, the one official place where every result is kept.
Every medicine has a specification, the list of tests a batch must pass and the limit for each. The limits come from the company's approved filing and from the pharmacopoeia, the official book of standards for medicines. In India, that book is the Indian Pharmacopoeia.
Say a tablet plant in Goa has just made a batch of 3 lakh blood-pressure tablets. A quality-control employee takes samples and scans their barcode. The LIMS logs the samples and looks up the specification. It creates four tests: appearance, assay (how much medicine each tablet holds), dissolution (how fast the tablet dissolves) and impurities. It assigns each test to an analyst who is trained on that method. It also checks that the instrument chosen for the test is calibrated, and refuses an instrument whose calibration date has passed.
The results arrive from the instruments, such as the chromatography systems, usually through lab instrument integration, so that nobody copies a number by hand. The LIMS compares each result with its limit. Three tests pass. But the impurities test shows 0.3% of one impurity, above the limit of 0.2%. The LIMS marks the result as out of specification, or OOS. It blocks the batch and opens an investigation in the quality management system (QMS). If the investigation finds a laboratory error and a retest passes, a person from the quality team approves the batch. The LIMS then prints a certificate of analysis, and the plant's manufacturing execution system is told that the batch may be released.
Every step is recorded with an audit trail, as GxP rules require. Inspectors from CDSCO, and from regulators in countries that buy India's medicines, often start an inspection by asking to see the LIMS records.
How is a LIMS different from a laboratory information system (LIS)? An LIS runs a hospital or diagnostic laboratory, where each sample belongs to a patient and the result goes to a doctor. A LIMS runs a laboratory where samples belong to batches, products or experiments.