A quality management system (QMS) for pharma is software that records every problem in a drug plant or laboratory, the investigation of each problem and the fix that follows. It also records the training that staff need, the changes made to processes and the complaints received from customers. The aim is that every record is ready when an inspector asks for it. It is also called eQMS, short for electronic quality management system.
The QMS handles several kinds of record. A deviation is any departure from an approved plan, such as a machine that ran too long. An out-of-specification result, or OOS, is a laboratory test result outside its allowed limits. CAPA, short for corrective and preventive action, is the fix for a problem, and the step that stops it from happening again. Change control is the approval needed before anyone changes a recipe, a machine or a document. Training records show that each employee has been trained on the current version of every procedure that they follow.
Say a tablet plant in Pune tests a batch of a painkiller. The test checks how much medicine dissolves from the tablets in 30 minutes. The limit is at least 80%. The result, recorded in the LIMS, is 72%. This is an OOS result, and the QMS opens a record for it. It assigns the investigation to a quality employee and sets a deadline of 30 days. The batch is put on hold. The investigation first checks that the test itself was done correctly, against the method in the pharmacopoeia. It then compares the batch's record in the manufacturing execution system with earlier batches. It finds that the powder was dried for 20 minutes longer than usual, which made the tablets too hard. The QMS then opens a CAPA. The written procedure for drying is changed, through change control. The 14 operators who dry powder are retrained, and the QMS records their training. After three more batches pass the test, the CAPA is closed.
All these records are linked. A year later, an inspector from CDSCO or the US FDA can ask for every OOS result of the last year. The quality team shows the list, with each investigation and fix, in minutes. With paper files, the same request can take days.
The QMS also receives failed tests from computer system validation, and complaints about packs traced by serialisation software. Many plants also study what inspectors have found elsewhere, with regulator inspection intelligence, and check their own records on those topics first. The rules that all these records follow are described in GxP compliance.
How is this different from a general quality management system? Factories, airlines and food companies also use a QMS. A pharma QMS follows the drug regulators' rules: its records need electronic signatures and an audit trail, and its workflows, such as OOS investigations, follow regulators' guidance.