Class B gowning per QA-SOP-014: hand wash → sterile coverall → hood → goggles → mask → second glove pair. Verify integrity at each step; record initials in the gowning log.
Two consecutive line-clearance failures require a Tier-2 deviation (NCR-002). Stop the line, page QA on-call, isolate the lot, and document with photos in the deviation record.
Built for process manufacturing
Pharma, biotech, medical device, food & beverage, specialty chemicals — anywhere a regulator cares whether the operator followed the procedure at the effective revision.
Operators ask plain questions on the floor — gowning, line clearance, batch changeover, deviation handling — and get the SOP answer cited at the current effective revision.
Author, route, and e-sign SOPs with full Part 11 lifecycle. Approvals, periodic review, change control, and the audit chain — all tamper-evident.
Build courses with video, image, PDF, and quiz lessons. Assign by labor class. Track read-and-acknowledge and competency sign-offs against the training matrix.
How it works
Drop in PDFs, Word, batch records, training videos, work-instruction images. We OCR, chunk, and stamp every revision. Lifecycle, owner, sensitivity, and review cadence are captured at intake.
Build courses from the SOP — modules, video lessons, knowledge checks, e-signed attestations. Assign by labor class. Auto-retrain when an SOP revises.
When the auditor walks in, you don’t scramble. Every SOP has its lifecycle, every signature its meaning, every training record its e-signed proof — exportable as one bundle.
The full eQMS, in one platform
Most QMS vendors stop at document control. Kalova covers the whole quality system — every module wired into the same audit chain, with AI in the slot where humans get tired.
What's different about Kalova
Plenty of QMS platforms can store an SOP. Plenty of AI tools can answer questions. Kalova is the only place both happen at the same time — every answer cites the controlled document at the effective revision, with a hash-chained audit trail behind it.
Every operator question is answered from your effective SOPs, with the source passage, version, and lifecycle state visible inline. If the procedure doesn't cover it, the bot says so — instead of guessing.
[Source N] references on every claimAuthor → review → approve → effective → periodic review → supersede. E-signatures with reason-for-change, hash-chained audit log, ALCOA+ posture. Built around how regulated companies actually run a QMS.
Web, Slack, WhatsApp, embedded public chat. Operators don't have to learn another system — they ask in the channel they already use. QA gets the audit trail in one dashboard.
Pricing
Kalova is built for regulated process manufacturing — pharma, biotech, medical device, food & beverage, specialty chemicals. Every deployment is configured for your quality system, your SOP library, your training matrix, and your inspection posture. We’ll scope a plan in one call.
Sandbox tenants are free for evaluation. Production tenants are quoted per site after a scoping call.