AI co-workers for pharma quality. Every decision still yours.

Mostly for the work around a quality decision, not the decision itself. AI co-workers take on the routine work. They check whether a result is out of specification, rate deviations, draft root cause findings and CAPA plans, read your calibration, CAPA and deviation records to find audit gaps, and write the final reports. A qualified person in your QA team still reviews and signs every step.

No. The co-worker suggests what to do with the batch and shows its reasoning. But release, rejection, declaring a result invalid and closure are always signed by your qualified person. It stops at each of those points and records who approved what, and when. Your QA, QC and production heads spend their time on decisions, not the write-up.

Yes, with your people. The co-worker rates the deviation as minor, major or critical, using fixed risk rules based on ICH Q9, the international guideline on quality risk. It asks the area owner for the findings and works through a 5-Why with them, asking "why" until the real cause shows. It looks past "operator error" to the gap in the system behind it. Then it drafts the immediate correction, the corrective action and the preventive action, with named owners and dates. It does not close the CAPA until a follow-up check shows the fix worked.

Testing into compliance means retesting an out-of-specification result again and again until a passing number appears, then reporting that one instead. FDA guidance calls it unscientific and objectionable under CGMP. The OOS co-worker will not declare a result invalid unless the Phase I lab investigation has recorded a real lab error. It will not go past the retest limit in your SOP. The original result always stays on the record.

Revised Schedule M is India's updated Good Manufacturing Practice (GMP) rule for medicines. It was notified in December 2023 and is in line with WHO GMP. Larger manufacturers had to comply first. The extra time for MSMEs (micro, small and medium enterprises) ended on 31 December 2025. So it now applies to every manufacturing site it covers, and CDSCO and state inspectors are checking it. It expects a pharmaceutical quality system, quality risk management, regular self-inspections, and traceable records with an audit trail, a log of who did what and when.

Yes. The TGA applies the PIC/S Guide to GMP. It asks for the same core processes the co-workers run: investigating out-of-specification results, taking significant deviations to a root cause and a CAPA, and self-inspections on a planned schedule. Today the co-workers' rule references are FDA, ICH and Revised Schedule M. For an Australian site, we add the PIC/S clauses your SOPs work to as part of the build. Your QA still signs every step.

Part 11 (the US rule on electronic records and signatures) and ALCOA+ (the standard for trustworthy data) are about how records and signatures are kept. Your company stays accountable for them. The co-workers are built to support that. Every comment, finding and sign-off is kept with a time and a name, nothing is deleted, and the final report is attached to the record. Before it is used for real decisions, we plan its validation with your QA, on your own procedures. Validation means formally proving it does what it should.

No. It works alongside your QMS (quality management system), or alongside your spreadsheets if you have no QMS yet. A chatbot or copilot answers one person's question. A co-worker takes charge of a case from start to finish. It moves the ticket between people, runs the checks, drafts each record, and hands work to the next co-worker.

Yes. You do not need a new QMS first. The self-inspection co-worker was built to read the calibration logs, CAPA registers and deviation logs that most sites already keep in Excel. Things get more organised as you go.

Your people review every step before it counts, so a mistake is caught at sign-off, not after. The facts that matter most, like whether a result is out of specification or a calibration is overdue, are worked out by fixed rules, not written by the AI. It cannot see your shop floor or instruments, so it asks your people for evidence instead of guessing.

That is your call. We can run it in your country, inside your own cloud account, or on your own servers, so your batch and quality records never leave your control. Your current rules on who can see what stay as they are. We do not use your data to train our models.

Your first co-worker is usually working within 4 to 8 weeks. Start with one process. Deviations and CAPA is a good first choice, because it touches every department. So is a self-inspection, because it shows exactly where the gaps are. Once the first co-worker is working, the next one joins the same task board.