Trusted by quality teams in regulated pharma
Quality management,
engineered for pharma.
Zixov brings documents, training, batch records, change control, deviations, and CAPA into one audit-trailed platform — so your quality system runs itself and your next inspection is a formality.
Quality overview
Site: Ahmedabad — Unit 1
Effective documents
1,284
+12 this month
Trainings due (7d)
18
94% on time
Open deviations
3
0 overdue
CAPA effectiveness
96%
+2.1% QoQ
Pending approvals
Granulation — line 2 cleaning
SOP-100234
QA approval
Today
Purified water loop sensor upgrade
CC-2026-041
Impact review
Tomorrow
Sampling of raw materials v4.0
SOP-100198
Approved
Effective 01 Aug
8
integrated quality modules
100%
of actions audit-trailed
0
paper binders required
IQ/OQ
validation pack included
The problem
A paper quality system fails you on the day it matters most
Binders, shared drives, and spreadsheet trackers work — until an inspector is on site, a batch is on hold, or a document can't be found. That's when the cost shows up.
The audit scramble
Weeks of pulling binders and reconstructing history before every inspection — with no guarantee it's complete.
Version confusion
Two "current" SOPs, an operator working from a superseded copy, and no single source of truth to settle it.
Data-integrity gaps
Undated edits, missing signatures, and gaps an auditor can drive an observation straight through.
Findings & delays
One documentation observation can escalate into a 483, a warning letter, and a batch that ships late.
Zixov replaces all of it with one audit-trailed system — so the day it matters most becomes the day it barely registers.
How Zixov works
From paper chaos to a living quality system
Digitize
Migrate SOPs, training matrices, and master data into governed, versioned records — imports and templates included.
Control
QA-configured workflows route every review, approval, deviation, and change through the right people with e-sign-ready gates.
Prove
Immutable audit trails, one-click reports, and inspection-ready dashboards turn every audit into a walkthrough.
The platform
Eight modules. One source of truth.
License what you need today, switch on the rest when you grow — core quality processes are always included.
Document Management
Controlled documents from draft to obsolescence
Licensed moduleTraining Management
Prove every employee is qualified, always
Licensed moduleBatch Record Management
Right-first-time electronic batch records
Licensed moduleChange Control
Every change assessed, approved, and closed
Core — always includedDeviation Management
Capture, investigate, and close deviations fast
Core — always includedCAPA Management
Corrective and preventive actions that stick
Core — always includedHR Management
The people foundation of your quality system
Core — always includedMaster Data Management
One source of truth for your quality data
Core — always includedWhy Zixov
Not a generic tool bent to fit pharma
Most quality software is a workflow engine with a GxP label bolted on. Zixov is built the other way round — quality first, everything else in service of it.
Purpose-built for GxP
Workflows modeled on real SOPs, batch records, and audit findings — not generic BPM abstractions you have to twist into shape.
Modular — start small, grow later
Core quality processes are always included. License documents, training, or batch records only when you need them, so you never pay for capability you don't use.
Validation done with you
IQ/OQ templates, requirements traceability, and release notes ship with the product — so computer system validation is a head start, not a project from zero.
Software your team will actually use
Fast, clear, and modern. A quality system only protects you if people work inside it — so adoption is a design goal, not an afterthought.
Compliance is the product
Built for the audit you haven't scheduled yet
Every record in Zixov is attributable, time-stamped, and tamper-evident. When the inspector arrives, your evidence is one search away — not one basement away.
Read our compliance approachImmutable audit trail
Every create, edit, approval, and issuance — permanently recorded.
E-signature ready
Signature meaning, identity, and timestamp on every approval gate.
Role-based access
Granular permissions per module, workflow step, and record state.
Validation pack
IQ/OQ templates and traceability documents ship with the product.
Standards & guidelines
Built to the regulations your auditors live by
Zixov is designed from the ground up to help you meet the GxP standards that govern pharmaceutical manufacturing — not retrofitted for them afterwards.
Electronic records & signatures
Access controls, audit trails, and compliant e-signatures on every record and approval.
Computerised systems
Risk management, secure data storage, printouts, and periodic system evaluation.
Computer system validation
A risk-based validation approach, backed by supplier documentation and traceability.
Data integrity
Attributable, legible, contemporaneous, original, accurate — and complete, consistent, enduring, available.
Pharmaceutical quality system
A connected quality system across the product lifecycle, with management review built in.
Quality risk management
Risk assessment woven through change control, deviations, and CAPA decisions.
Documentation
Controlled, versioned documents with a full lifecycle from draft to obsolescence.
Good manufacturing practice
Practices and record-keeping aligned with WHO GMP expectations for manufacturing.
Zixov provides the controls, records, and documentation to support compliance with these frameworks. Final validation and regulatory compliance remain the responsibility of each manufacturer — and we supply the validation pack to make that straightforward.
See our full compliance approachZixov is new — and that's exactly why the first manufacturers to join get the most out of it
As a founding customer you work directly with the team that builds the product: hands-on onboarding, validation support, and real influence over the roadmap. No call-center tiers, no waiting in a queue behind ten thousand other accounts.
Before you ask
The questions buyers actually ask
How is Zixov priced?
Modular — per site and per module, so you only pay for what you switch on. Core quality processes are included in every plan, and we quote after a short scoping call so the number fits your footprint.
How long does implementation take?
Weeks, not the multi-quarter slog legacy eQMS is known for. A focused Core QMS rollout goes live quickly, and we migrate your documents and data with you rather than handing you an empty box.
Will it hold up in an FDA or EU inspection?
It's built around 21 CFR Part 11 and EU Annex 11 from day one — attributable actions, immutable audit trails, and compliant e-signatures on every approval gate.
Do we have to validate it ourselves?
No. IQ/OQ templates, requirements traceability, and release notes ship with the product, and we support your computer system validation so it's a head start, not a project from zero.
Can we migrate our existing SOPs and data?
Yes. Imports and templates are included, and we bring your controlled documents, training matrices, and master data across as governed, versioned records.
Where is our data hosted, and is it secure?
Role-based access, encryption, and automated backups are standard. Prefer to keep data in-house? On-premise deployment is available on Enterprise.
See Zixov running on your own SOPs
Bring one document and one workflow to a 30-minute demo — we'll show you both live in Zixov.