Kalova
Log inTalk to sales
cGMP · 21 CFR Part 11 · ISO 13485 · ISO 14971

The eQMS your operators actually use.

Operators talk to your SOPs in plain English — every answer cites the controlled document at the effective revision. Underneath sits a full eQMS: change control, deviations, CAPA, risk, complaints, audits, equipment, training, vendor qualification — one platform, one audit trail.

Talk to sales See it in 90 seconds
21 CFR Part 11 e-signatures ALCOA+ audit trail Validated install (IQ/OQ)
kalova.io/chatlive
Recently asked
Ask kalova anything about your SOPs…

Built for the regulators who walk into your office

cGMP21 CFR Part 1121 CFR 803 / EU VigilanceISO 13485ISO 14971EU GMP Annex 11ICH Q10GAMP 5ALCOA+cGMP21 CFR Part 1121 CFR 803 / EU VigilanceISO 13485ISO 14971EU GMP Annex 11ICH Q10GAMP 5ALCOA+

Used by quality teams across pharma, biotech, MedTech, supplements, F&B, and specialty chemicals.

0%
Of answers cite a controlled SOP
Citation-grade RAG. If the procedure doesn't cover it, the bot says so — instead of guessing.
0→0
Months to days
Replace 9-month MasterControl/Veeva implementations with a 30-day Kalova rollout.
0
Modules. One audit trail.
Documents through complaints — every record threads through the same hash-chained log.

The full eQMS

Twelve modules. One audit trail.

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.

Documents & SOPs
Chat with cited answers · lifecycle · versioning · e-sign · periodic review
Change control
AI impact assessment · dual-signature gates · CCB review · effective-date scheduling
Deviations / NCR
AI 5-Whys · severity classification · CAPA linkage · trend grouping
CAPA
Action plans · owner sign-off · effectiveness checks · vendor responses
Risk (ISO 14971)
Hazard chains · AI hazard + control suggester · drag-drop matrix · benefit-risk
Customer complaints
eMDR decision tree · 21 CFR 803 / EU Vigilance reportability · 30-day countdown
Audits
Internal + supplier · AI checklist gen · finding tracking · mobile walkthrough
Equipment & calibration
OOT auto-deviation · QR-code labels · due-date calendar · IQ/OQ/PQ records
Training & LMS
Courses · learning paths · AI quiz gen · competency signoff · training matrix
Vendor qualification
Qual questionnaires · audit findings · CoA / GMP cert tracking · scorecards
Workflow Studio
Visual flowchart builder · AI generate from SOP · PNG / SVG / Visio export
Recurrence trending
AI clusters root causes · surfaces systemic gaps · cross-module rollups

Documents & SOPs

Talk to your SOPs.

Operators ask plain questions on the floor. Kalova answers from the controlled SOP at the effective revision — and cites the exact passage inline.

  • Every claim links to a passage in the source
    Citation chips on the answer point to the highlighted passage in the controlled SOP.
  • Knows what is and isn't in your library
    Says "not in the procedure" instead of guessing. Term-fidelity guard catches drift.
  • Lives where the work happens
    Web, Slack, WhatsApp, embedded public chat — same answers, same audit trail.
See documents →
kalova.io/chat · groundedCited at v6
Kalova answer
Grounded in the controlled SOP
QA-SOP-014 Aseptic gowning v6.pdf
Effective
QA-SOP-014 — Aseptic gowning, Grade B
Effective: 14 Mar 2024 · Revision 6
 
4.0 Gowning sequence (Grade B)
4.1 Operator shall hand wash and dry hands per the
gowning anteroom protocol prior to suit donning.
4.2 Don sterile coverall, hood, goggles, and surgical
mask. Inspect each garment for visible defects.
4.3 Sanitize hands with 70% IPA, then don second
glove pair over the coverall cuff.
 
5.0 Recordkeeping
5.1 Each step in §4 shall be initialed in the
gowning log (Form QA-FRM-014) before line entry.
p. 3 of 7
Every claim links back to the procedure at the effective revision.

Change control · Workflow Studio

Visual change control. AI-assisted.

Every SOP becomes a workflow you can read at a glance. Change requests run through impact assessment, CCB review, and effective-date scheduling — automatically.

  • AI impact assessment fills the boring fields
    Affected SOPs, training records, equipment, risk items — surfaced in one pass.
  • Dual-signature gates before effective
    Author / approver separation enforced. Reason-for-change captured every revision.
  • Workflow Studio exports to Visio / SVG / PNG
    Generate the flowchart from the SOP, hand it to inspectors, drop it in your audit pack.
See change control →
Change request
Impact assessment
CCB review
Verification
Effective

Training & LMS

Training that actually completes.

Build courses from the SOP. Assign by labor class. Auto-retrain when the procedure revises. The training matrix is always current — and inspector-ready.

  • Auto-retrain on SOP revise
    When QA-SOP-014 v6 supersedes v5, every qualified operator is re-assigned the delta.
  • Floor-friendly course player
    Video, image, PDF, and quiz lessons. Works on iPad and shop-floor PCs.
  • Training records ready for inspection
    Read-and-acknowledge + competency e-sign, exportable as one bundle.
See training →
Training matrix
Live
RoleSOP-014SOP-007SOP-019SOP-022
Operator I
Operator II—
QA Specialist
Lead Tech—
Validation
Maintenance——
22 of 24 qualified Auto-retrain on SOP revise

How it connects

Every action ends in the same audit trail.

A single document edit threads through approval, training, the floor, and back into change control. Twelve modules, one append-only chain.

Step 01
Document edit
Documents
Step 02
Approval
E-sign
Step 03
Effective
Lifecycle
Step 04
Training assigned
LMS
Step 05
Operator signed
Floor
Step 06
Deviation linked
NCR
Step 07
CAPA opened
CAPA
Step 08
Change request
CCB

Hash-chained audit log. Every signature, every record, every artifact — verifiable on demand.

Built for process manufacturing

One platform for documents, training, and quality.

Pharma, biotech, medical device, food & beverage, specialty chemicals — anywhere a regulator cares whether the operator followed the procedure at the effective revision.

Production operators

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.

  • Floor-friendly on iPad and shop-floor PCs
  • Always answers from the controlled SOP
  • Says "not in the procedure" instead of guessing

Quality assurance

Author, route, and e-sign SOPs with full Part 11 lifecycle. Approvals, periodic review, change control, and the audit chain — all tamper-evident.

  • Author/approver separation enforced
  • Reason-for-change captured at every revision
  • One-click inspection bundle export

Training & qualification

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.

  • Auto-assign retraining when the SOP changes
  • iPad-friendly course player for the floor
  • Training records ready for inspection

How it works

From PDFs to answers in three steps.

01

Migrate your SOP library

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.

QA-SOP-014 Aseptic gowning v6.pdfEffective
MFG-WI-022 Line clearance v3.docxEffective
Bosch FXS-3120 final test.mp4Processing
02

Train and qualify your operators

Build courses from the SOP — modules, video lessons, knowledge checks, e-signed attestations. Assign by labor class. Auto-retrain when an SOP revises.

Course
Aseptic gowning · Class B
Assigned to
Operator I, QA Specialist
17 of 18 qualified
03

Stay inspection-ready

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.

Show the FDA the signed-and-effective gowning SOP plus all training records.
Inspection bundle ready: SOP v6 (effective), 18 training acks, 4 deviations linked.
Audit chain: verified

vs. the alternatives

Both, done right.

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.

MasterControl, Veeva, TrackWise
Traditional eQMS
  • 6–9 month implementations with hand-coded workflows
  • No AI in the operator loop — all chat is human-only
  • Forms-heavy UX that operators avoid using
Citation-grade AI, on a real eQMS
Kalova
  • Talk-to-SOPs with inline source citations
  • Twelve modules, one hash-chained audit trail
  • 30-day rollouts. AI fills the boring fields.
ChatGPT, Copilot, Notion AI
Generic AI tools
  • No lifecycle — answers from any draft, any version
  • No e-signature, no audit trail an inspector trusts
  • No connective tissue to deviations / CAPA / training

Proof on the floor

Concrete answers, not slideware.

Talk to SOPs
Class B gowning question
What’s the gowning sequence for Class B?
Per QA-SOP-014 (effective): hand wash → sterile coverall → hood → goggles → mask → second glove pair.
QA-SOP-014 v6
Deviation → CAPA
Line-clearance double failure
Operator: 2× line-clearance failure on Line 3
Tier-2 deviation NCR-002 opened automatically
AI 5-Whys → root cause: changeover SOP gap
CAPA-014 owner sign-off · effectiveness check scheduled
Inspector view
Training matrix snapshot
Training matrix
Live
RoleSOP-014SOP-007SOP-019SOP-022
Operator I
Operator II—
QA Specialist
Lead Tech—
Validation
Maintenance——
22 of 24 qualified Auto-retrain on SOP revise

Concrete examples from real customer pilots — Catalent, Sigma-Aldrich, and others. Names anonymized.

Honest answers

Questions QA teams always ask first.

Does Kalova train its AI on our SOPs?
No. Your SOPs and chat logs are stored in your tenant only. We use OpenAI with the no-training flag set on every API call, and a BAA is available for HIPAA-adjacent deployments. Embeddings stay in your tenant’s pgvector store.
How long does implementation take?
A typical regulated-industry implementation is 30 days end-to-end: SOP migration, lifecycle mapping, training-matrix import, and first round of operator onboarding. Most legacy QMS migrations budget 6–9 months — that timeline assumes manual workflow rebuilds we avoid because every SOP ingest produces the workflow automatically.
How do you migrate from MasterControl, Veeva, or TrackWise?
Two-step. First, we ingest your current SOP library (PDF / DOCX export is enough). Lifecycle, owners, and revision history map automatically to Kalova’s schema. Second, we replay your active records — open deviations, CAPAs, change controls — into Kalova by API or CSV. Audit history is preserved with original timestamps and signed evidence attached.
Do you ship a validated install (IQ/OQ/PQ)?
Yes. Every production tenant ships with an IQ/OQ packet (installation + operational qualification scripts), test evidence, and a validation summary. PQ is run jointly with your QA team against your specific SOP library and process flow.
Where is Kalova hosted?
Kalova runs on Railway with Postgres + pgvector by default. We also deploy to your AWS, GCP, or Azure tenant on request — same container image, your VPC, your KMS keys.
What does it cost?
Pricing is per site, not per seat. We scope a plan in one call — SOP volume, modules in scope, hosting model. Sandbox tenants are free for evaluation. Most regulated-process customers land between $40k and $120k a year for a single site.
Can we export our data?
Anytime. SOPs export as the original file plus a JSON sidecar with lifecycle and signature metadata. Records export as CSV and the full audit trail exports as a verifiable hash-chained log. There is no lock-in — your data is your data.
How is the audit trail tamper-evident?
Every record write is hashed with the previous record’s hash, forming an append-only chain. Hashes are stamped server-side and the chain is verifiable on demand by re-walking it from genesis. ALCOA+ attributes (who/what/when, original, accurate, contemporaneous) are captured at the row level.

Pricing

Priced to match your site, not your seat count.

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.

Included
Validated install + IQ/OQ packet
Included
21 CFR Part 11 e-sign workflow
Included
Inspection-mode bundle export
Talk to sales Start a sandbox tenant
Talk to a quality engineer
We’ll reply in 1 business day.
  • 30-minute scoping call — site, SOP volume, modules in scope.
  • Sandbox tenant inside 48 hours, loaded with your sample SOPs.
  • Pricing scoped to your site footprint, not seat count.
sales@kalova.io

Run your QMS like an inspector lives in your office.

Kalova is a real quality system that operators want to use and inspectors are happy to see. Book a scoping call and we’ll have a tenant ready for you to evaluate in days.

Talk to sales Read the docs