Partner disclosure
Our relationship with Opsona
Opsona.ai makes operation-intelligence software for regulated manufacturing, designed to orchestrate production. It’s a sister company to us and to Decimal, and we disclose the relationship so you can weigh every sentence on this site that touches a computerized system.
Four layers of a plant · select one to see what applies
The software. It’s the operating layer of a regulated plant: records, deviations, change control, training, and the audit trail. Opsona is built for this layer, but it is not a GMP certificate.
What Opsona is
Opsona is an operating layer for a regulated plant, covering records, deviations, change control, training, and the audit trail. The company describes it as “the operating system for regulated manufacturing.” If you run an extraction lab and have read this site, you’ll recognize the gap it’s aimed at: the documentation that has to let you reconstruct a batch.
What Opsona is not
Opsona is not a GMP certificate. Computerized systems are validated in context (see EU GMP Annex 11, 21 CFR Part 11, and the FDA’s Computer Software Assurance guidance), in the same way that equipment is qualified in place. Buying a software platform is not the same as having your production suite inspected. The same goes for hardware: equipment is not certified either.
How Opsona relates to this site
GMPEquipment.com teaches what the published text says. Charlie doesn’t answer questions until a named expert has signed the guides. If you use Opsona, that’s where your own records would be kept, and we won’t pretend that this educational site is that system. In short, Decimal builds the equipment, Opsona runs the records, and this site explains the standards.
The rule is the same as for Decimal: we mention Opsona after we’ve explained the requirement, never in place of the explanation, and we never present “GMP software” as if it were a seal of approval. For more, read the Decimal disclosure and our editorial policy.