Compliance is the product
Built for the audit you haven't scheduled yet
Zixov was designed for GxP-regulated pharmaceutical manufacturing from day one — not retrofitted for it. Here is how the platform maps to the regulations your auditors care about.
Attributable actions
Every record change is tied to a unique, authenticated user. Shared accounts are impossible by design.
Immutable audit trail
Time-stamped, tamper-evident audit trails on every entity — documents, batches, deviations, CAPAs, and master data.
Electronic-signature-ready
Approval gates capture meaning, signer identity, and timestamp in line with 21 CFR Part 11 expectations.
Role-based access control
Granular permissions per module, per workflow step, and per record state — administered by QA, not IT tickets.
ALCOA+ data integrity
Data is attributable, legible, contemporaneous, original, and accurate — plus complete, consistent, enduring, and available.
Validation documentation
We supply validation support packs — requirements traceability, IQ/OQ templates, and release notes — to accelerate your CSV effort.
Regulatory alignment
FDA 21 CFR Part 11
Electronic records and signatures: access controls, audit trails, signature manifestation, and record retention.
EU GMP Annex 11
Computerised systems: risk management, data storage, printouts, audit trails, and periodic evaluation.
GAMP 5 (2nd edition)
Risk-based validation approach supported by supplier documentation and requirements traceability.
Or explore the eight modules first.