Pharma Identity & Access Governance

Secure, Unified Access Management
for Regulated Pharma Operations

Control user access, enforce GxP compliance, and streamline identity governance across your pharmaceutical ecosystem with centralized, audit-ready access management aligned with FDA 21 CFR Part 11 and EU Annex 11 requirements.

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Identity & Access Control

Comprehensive lifecycle management. From onboarding to role assignments, manage unique identities across multiple sites and departments.

User Master

Creation, modification, onboarding, and multi-site handling.

RBAC

Granular permission control, dynamic inheritance, least privilege.

Self-Service Portal

Access requests, password resets, and approval tracking.

Temporary Access

Emergency break-glass access and time-bound provisioning.

Workflows & Monitoring

Maintain oversight with intelligent monitoring, periodic reviews, and strict qualification-based access linked to LMS training.

Approval Workflow

Multi-level approvals, QA checks, and mandatory validations.

Training-Linked Control

SOP verification and auto-revocation on training expiry.

Audit Trail

Complete logging, IP tracking, and review dashboards.

Periodic Review

Quarterly reviews, recertification, and dormant account flags.

Integration

LIMS, QMS, ERP, CDS, MES, and HRMS seamless syncing.

Risk Intelligence

AI anomaly detection, risk scoring, and unusual activity alerts.

Compliance & Security

Maintain oversight with intelligent monitoring, periodic reviews, and qualification-based access.

GxP Compliance

21 CFR Part 11, EU Annex 11, ALCOA+, and e-signatures.

Segregation of Duties

Toxic role identification and maker-checker enforcement.

Authentication

MFA, SSO, Active Directory, LDAP, and biometric login.

Validation Docs

IQ/OQ/PQ documentation and validation traceability.

Tailored for Pharma Operations

Pre-configured roles and dedicated dashboards designed specifically for pharmaceutical workflows and compliance monitoring.

Pharma-Specific Roles by Department

QC

Analyst

Reviewer

QA Approver

QA

QA Reviewer

QA Admin

Production

Operator

Supervisor

Clinical

CRA

CRC

Medical Reviewer

Warehouse

Store Executive

Engineering

Instrument Admin

IT

System Administrator

Regulatory

Submission Reviewer

Important Dashboards

Active Users Dashboard

Locked Users Dashboard

Pending Approval Dashboard

Access Review Dashboard

SoD Conflict Dashboard

Training Pending Dashboard

Audit Trail Dashboard

Expired Access Dashboard

Site-wise Access Dashboard

License Utilization Dashboard

Seamless Access Across the Zentixs Ecosystem

A unified framework managing role templates, verifying training status, and maintaining full audit readiness across all connected applications.

Zentixs Labs

LIMS Integration

Analyst & Reviewer roles

Instrument admin control

SoD enforcement

Zentixs Track

QMS Integration

QA Approver permissions

Multi-level change control

Audit trail review

Zentixs Eye

MES/eBMR Integration

Operator & Supervisor roles

E-signature enforcement

Batch release SoD

Zentixs Caliber

ERP/SAP Integration

Cross-system license tracking

Store Executive mapping

Automated onboarding

Zentixs Desk

DMS Integration

Read/Write/Approve granular rights

Controlled print access

Periodic access review

Zentixs iBook

LMS Integration

SOP & Protocol verification

Auto-revocation on expiry

Qualification-based access

Frequently Asked Questions

Pharma IAM centralizes user identities, roles, permissions, and access workflows to ensure employees have appropriate, controlled access to regulated systems and data.

RBAC enforces least-privilege access by assigning permissions based on job responsibilities, reducing unauthorized access and supporting GxP data integrity and compliance.

A compliant identity management system supports unique user identification, secure authentication, electronic signatures, audit trails, and controlled access to electronic records.

Training-linked access ensures users receive system permissions only when required training or SOP qualifications are current, with access automatically restricted when training expires.

Centralized audit trails, access reviews, approval records, role histories, and dashboards provide documented evidence of who had access, what permissions they held, and how access was controlled.

Periodic access review verifies that user permissions remain appropriate as roles change, helping identify excessive, dormant, expired, or conflicting access before it creates compliance risks.

Pharma & Biopharma

Quality Management

Laboratory Management

Production Management

Equipment Management