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Control Sample Management
Built for Pharma

Digitize every stage of your control sample lifecycle—from batch collection to destruction—with full GMP traceability and zero paperwork.

Control Samples
That Are Always
Audit-Ready

Zentixs Vault manages the entire reserve sample lifecycle from registration, location allocation, chain-of-custody, visual inspections, and destruction, eliminating paper trails and closing the gaps auditors always find first.

Vault

Why it Matters

Control samples are critical evidence at every stage of your product's lifecycle.

Complaint Investigation

Pharma companies must retain control samples for every batch as physical proof of product quality.

Regulatory Inspections

Present complete audit-ready records to FDA, WHO or EU inspectors

Product Quality Management

Re-test samples at any point to confirm product integrity over time.

GMP Documentation

Maintain lifecycle-long records that satisfy all GMP documentation requirements.

Sample Lifecycle in 5 Steps

From the moment of batch packing to final destruction — every step tracked, every action traced.

Step 01

Collect & Register

Samples auto-registered from production batch records. Quantity, batch ID, and product details captured instantly.

Step 02

Label & Verify

Unique barcodes generated, GMP-compliant labels printed, and QA receipt confirmed with electronic signature.

Step 03

Store & Monitor

Assigned to temperature-controlled storage locations with continuous environmental condition tracking.

Step 04

Inspect & Issue

Scheduled visual inspections with guided checklists. Multi-level approval workflow for sample withdrawal.

Step 05

Reconcile & Destroy

Quantity reconciliation at every stage. Post-retention destruction authorized, documented, and archived.

Everything in One Platform

12 purpose-built modules that cover every step of the control sample lifecycle — nothing bolted on.

Batch-wise Sample Collection & Labeling

Samples auto-linked to production batch records; unique barcodes and GMP-compliant labels generated for every sample collected. .

QA Receipt & Storage Management

Digital QA acknowledgement with e-signatures; samples tracked to exact shelf, chamber, and facility with real-time inventory.

Environmental Monitoring

Temperature and humidity conditions logged per sample, with alerts for out-of-spec events.

Inspection & Withdrawal Workflows

Guided visual inspection checklists with photo capture, plus configurable multi-level approval for sample issuance and withdrawal.

Retention Tracking & Destruction

Auto-calculated retention end dates with proactive alerts; authorized, documented destruction with witness signatures and photo records.

Audit Trail & 21 CFR Part 11 Compliance

Immutable, timestamped log of every action, plus electronic signatures and access controls built to satisfy 21 CFR Part 11.

Built for Global Compliance

Zentixs Vault is validated against all major international pharmaceutical regulatory frameworks.

21 CFR Part 11

Support compliant electronic records with secure audit trails and electronic signatures.

GxP Guidelines

Help organizations align quality processes with global regulatory requirements.

GLP Standard

Support laboratory compliance with traceable records and reliable data management.

ALCOA+ Principles

Promote data integrity with accurate complete and traceable digital records.

EU Annex 11

Enable validated computerized systems with strong data integrity controls.

GMP Support

Digitize manufacturing workflows with controlled documentation and process visibility.

GCP Protocol

Facilitate compliant clinical documentation and study process management.

ICH Q10 Framework

Support operational quality systems with risk based and standardized processes.

Industries We Serve

Pharmaceutical Companies

Biopharmaceutical Organizations

Medical Device Companies

Clinical Trial Organizations

Analytical Laboratories

Life Sciences Organizations

The Only Pharma-Native Control Sample Platform

Trusted by 500+ pharmaceutical companies to manage billions of control samples with zero compliance gaps.

End-to-End Digital Lifecycle

From batch packing to sample destruction — every step in one platform.

Configurable to Your SOPs

Adapt workflows without custom development. Go live in weeks, not months.

Real-Time Dashboards

Live sample status, overdue alerts, and inspection schedules at a glance.

Multi-Site Traceability

Manage samples across manufacturing sites with centralized visibility.

Validation-Ready

IQ/OQ/PQ documentation and full validation support included out of the box.

Pharma-First Design

Purpose-built for pharmaceutical manufacturing. Not a generic tool adapted for pharma.

Let the System
Do the Work

Replace manual tracking and paper reminders with intelligent automation that keeps every sample on schedule and in compliance — automatically.

Zero missed inspections
100% sample accountability
Audit-ready at all times
Auto Sample Registration

Samples auto-registered from production batch events—no manual data entry required.

Barcode Generation

Unique barcodes created instantly upon sample registration and linked to batch.

Inspection Reminders

Automated alerts for upcoming periodic visual inspection schedules.

Retention Period Alerts

System auto-calculates retention end dates and alerts responsible staff in advance.

Destruction Due Notifications

Timely notifications when samples reach end of retention period.

Electronic Approvals

Configurable multi-level approval workflows with 21 CFR Part 11 e-signatures.

Seamless
Integrations

Connect Zentixs Vault with the entire Zentixs ecosystem to unify data, documentation, and compliance workflows. Link physical samples to electronic quality events effortlessly.

Zentixs Docs
Zentixs Docs
Document Management System
Zentixs Labs
Zentixs Labs
Laboratory Management System
Zentixs Track
Zentixs Track
Quality Management System
Zentixs Stability
Zentixs Stability
Stability Management System