A manufacturing LIMS keeps the plant's QC bench: the raw material lot received, the in-process sample pulled, the finished lot tested and released, with the instrument and its calibration against every test. LIMS manufacturing use is judged by the release: whether the lot can ship is a lookup on the record or a phone call to the lab. LIMS for manufacturing therefore carries the lot as the unit, and GxP compliance software or ISO 17025 software sold separately are the same record described by the rule it satisfies rather than the work it does. This page is about that record for a small plant, and the free instrument calibration sheet on this site works the calibration cost per instrument from the lab's own numbers with no account.
The lot as the unit of record
Raw material lots with their supplier and certificate, in-process samples with their stage, finished lots with their tests and their release status: three kinds of lot, one record. A manufacturing LIMS that keeps the samples without the lot cannot answer the release question, and the release question is the plant's whole reason for the lab.
Calibration as a cost and a record
Every test cites the instrument and the instrument cites its last calibration; a result on an out-of-calibration instrument is the finding every audit looks for. The instrument calibration sheet on this site works the cost: 12 instruments calibrated four times a year at two analyst hours and a $150 fee each is $11,520 a year, $960 an instrument, on the worked example.
GxP and ISO 17025 as the same record
GxP compliance software keeps the record the regulated plant's rules describe; ISO 17025 software keeps the record a testing and calibration laboratory's accreditation describes; both ask for personnel, method, equipment, sample identity, results and review with an audit trail. The record is one; the rule the plant's quality manager reads is theirs. Limslane Pro keeps the record at one flat price.
Questions people ask about manufacturing lims
What is a manufacturing LIMS?
The plant's QC record: raw material, in-process and finished lots with their tests, instruments, calibration and release status, and the arithmetic worked from it.
Is ISO 17025 software different from GxP compliance software?
Both are the lab record described by a rule; the record is the same, the rule is the plant's own to read.
What does calibration cost a small plant lab?
Instruments times calibrations times analyst hours and fees: $11,520 a year on the worked example, from five figures on the free calibration sheet.