The platform
Eight modules. One quality system.
Zixov is modular by design. Core quality processes — change control, deviations, CAPA, HR, and master data — are always included. License document management, training, and batch records as you need them.
Document Management
Controlled documents from draft to obsolescence
Author, review, approve, issue, and retire SOPs and controlled documents with a fully audit-trailed lifecycle. Version control, controlled copy distribution, and periodic review are built in.
- SOP authoring with structured templates and doc-control workflow
- Multi-stage review and approval with e-signature-ready sign-offs
- Controlled copy issuance, distribution, and retrieval tracking
Training Management
Prove every employee is qualified, always
Role-based training matrices tied directly to controlled documents. When an SOP changes, affected employees are automatically retrained and assessed before the new version goes effective.
- Role- and department-based training matrices
- Automatic retraining triggers on document revisions
- Read-and-understand, classroom, and assessment-based training
Batch Record Management
Right-first-time electronic batch records
Design master batch records, execute them electronically on the shop floor, and review by exception. Every entry is attributable, contemporaneous, and permanently recorded.
- Master batch record templates with activity sequencing
- Electronic batch execution with enforced step order
- In-process checks, dual verification, and deviations capture
Change Control
Every change assessed, approved, and closed
Manage planned changes across documents, equipment, processes, and systems. Impact assessment, cross-functional approval, implementation tasks, and effectiveness checks in one workflow.
- Change request initiation with classification and risk rating
- Cross-functional impact assessment routing
- Approval workflows with QA gate control
Deviation Management
Capture, investigate, and close deviations fast
Log planned and unplanned deviations, run structured investigations with root-cause analysis, and route to CAPA when needed — with QA oversight at every gate.
- Rapid deviation intake with severity classification
- Structured investigation and root-cause analysis tools
- Batch and product impact assessment
CAPA Management
Corrective and preventive actions that stick
Turn deviations, audit findings, and complaints into effective corrective and preventive actions. Track implementation, verify effectiveness, and close the loop with evidence.
- CAPA initiation from deviations, audits, and complaints
- Action planning with owners, due dates, and escalations
- Implementation evidence and verification steps
HR Management
The people foundation of your quality system
Maintain employees, roles, departments, and reporting lines that power training assignments, approval routing, and access control across every module.
- Employee records with roles, departments, and sites
- Job descriptions linked to training requirements
- Organization structure driving workflow routing
Master Data Management
One source of truth for your quality data
Centrally govern products, materials, equipment, sites, and code lists used across the suite — so every record in every module speaks the same language.
- Governed registries for products, materials, and equipment
- Site, area, and department hierarchies
- Controlled code lists and classifications
How licensing works
Pay for what you switch on — nothing more
Core is always on
Change control, deviations, CAPA, HR, and master data ship with every plan — your quality backbone from day one.
Add modules as you grow
Switch on documents, training, or batch records when you need them. Activation is configuration, not a new project.
One connected suite
A deviation can raise a CAPA; a change can trigger document revisions and retraining — with nothing re-entered.
FAQ
Questions about the modules
Which modules are included as standard?
Core QMS — change control, deviations, CAPA, HR, and master data — is always included. Document management, training, and batch records are licensed as you need them.
Can I start with just one or two modules?
Yes. Begin with Core QMS or add a single module, and switch on the rest anytime — your data, users, and configuration carry straight over.
Do the modules actually talk to each other?
Yes. It's one platform on one data model, so records flow between modules automatically — a deviation raising a CAPA, a change triggering retraining — with nothing keyed in twice.
Is each module validated separately?
The modules share one validated platform. The validation pack — IQ/OQ templates and requirements traceability — covers the modules you license.
How are the modules priced?
Per site and per module, with Core QMS included in every plan. We quote after a short scoping call so the number matches your footprint.
Can we add modules later without re-implementing?
Yes. Turning on a new module is a configuration change, not a fresh rollout — no migration project, no downtime for the modules you already run.
Not sure which modules you need?
Tell us how your quality system runs today and we'll map it to the right starting set — in a 30-minute demo on your own processes.