What ISO 22716 actually asks of your software
ISO 22716 is organised around the idea that quality comes from controlled processes: personnel, premises, equipment, raw materials, production, finished products, quality control, and the treatment of deviations and complaints. Software doesn't have to be certified to the standard, but it has to make those controls real: who did what, to which batch, with whose approval, and what happened when something went wrong.
The test is simple. If an auditor asked about a deviation from six months ago, could you show the batch, the formula version, the investigation, the CAPA and the release decision in one place? If that takes an afternoon of folder searching, the software isn't doing its job.
