Secure. Compliant.
End‑to‑End Data Archiving.

A unified archival solution designed for regulated life sciences environments to manage hardcopy and electronic records with full project traceability, data integrity, and regulatory compliance.

What Zentixs Saga Does

Zentixs Saga provides a centralized, validated repository for long-term storage and retrieval of paper-based and digital records across studies, projects, products, and clients—ensuring permanent inspection readiness.

Life sciences archival and compliance management

Key Capabilities

Hybrid Archiving (Hardcopy + Softcopy)
  • Physical record indexing with location mapping
  • Secure electronic document archiving
  • Barcode / QR code support
  • Link physical and electronic records
Project & Study-Wise Archival
  • Archive by Project, Study, Protocol, Product, Batch, or Client
  • Metadata-driven classification for fast retrieval
  • Cross-link archived data with QMS, LIMS, ELN, eTMF, or CTMS
Compliance, Audit & Data Integrity
  • 21 CFR Part 11, EU Annex 11, GxP, ALCOA+ compliant
  • Role-based access control & version history
  • Complete audit trails (who, what, when, why)
  • One-click audit packages & read-only inspector access
Records Lifecycle Management
  • Record creation → review → approval → archival → destruction
  • Automated retention period tracking
  • Alerts for review, expiry, and destruction approval
  • Controlled destruction with approval workflows
Advanced Search & Retrieval
  • Global search across metadata and content
  • Filter by project, date, document type, owner, or status
  • Instant retrieval for audits and inspections
Secure Infrastructure & Readiness
  • On-premise or cloud deployment
  • Encrypted storage, backup & disaster recovery
  • Business continuity & inspection history tracking

Industries We Serve

Empowering diverse industries with tailored digital solutions, scalable technology, and results-driven innovation.

Pharmaceutical
Companies
Biopharmaceutical
Organizations
Manufacturing
Plants
Clinical Research
Organizations
QA / QC
Laboratories
Medical Device
Companies
Analytical
Laboratories
Life Sciences
Organizations

Archival Workflow

Streamline record preservation with approval-driven archival, intelligent tracking, and complete audit readiness.

Archival
User Request
Review & Approval
Decision
Acknowledgment
Archive & Store
Retrieval
Retrieval Request
Review & Approval
Decision
Access Granted
Denied
Disposition
Transfer Request
Review & Approval
Transfer Out

Business Benefits

  • Reduces audit and inspection risk
  • Eliminates paper loss and uncontrolled storage
  • Improves operational efficiency and traceability
  • Ensures long-term regulatory compliance
  • Scales across multiple sites and studies
pie

Why Choose This Archival Software?

  • Designed specifically to meet the stringent regulatory and compliance requirements of the life sciences industry
  • Supports comprehensive hybrid archiving of both physical records and digitally stored documents within a single system
  • Validation-ready platform with built-in support for IQ, OQ, and PQ documentation and execution
  • Enables seamless integration with existing enterprise systems, ensuring continuity of operations without disruption

Compliance Support

Streamlining regulatory processes with reliable, secure, and efficient compliance management solutions.

21 CFR Part 11

Support compliant electronic records with secure audit trails.

EU Annex 11

Enable validated computerized systems with data integrity.

GxP Guidelines

Align quality processes with global regulatory requirements.

GMP Support

Digitize manufacturing workflows with controlled documentation.

GLP Standard

Support laboratory compliance with reliable data management.

GCP Protocol

Facilitate compliant clinical documentation and process management.

ALCOA+ Principles

Promote data integrity with accurate complete digital records.

ICH Q10 Framework

Support operational quality systems with standardized processes.

Frequently Asked Questions

Zentixs Saga is a compliant archival management system designed to securely store, manage, and retrieve both hardcopy and electronic records for Pharma, CROs, and Life Sciences organizations.
Zentixs Saga supports archiving of physical documents, scanned records, electronic files, raw data, reports, SOPs, study documents, and regulatory submissions.
Yes. Zentixs Saga is designed to support compliance with GMP, GLP, GCP, 21 CFR Part 11, EU Annex 11, and data integrity principles (ALCOA+).
The system tracks box, file, rack, shelf, and location details, along with retention periods, access history, and retrieval requests for complete traceability.
Electronic records are secured through role-based access control, audit trails, encryption, controlled downloads, and version control.
Yes. It manages configurable retention periods, alerts for due or expired records, approval workflows, and documented destruction with full audit trails.
Zentixs Saga integrates seamlessly with Zentixs platforms such as QMS, LIMS, DMS, and external systems through secure APIs.
The system enables quick record retrieval, inspection-ready reports, access logs, audit trails, and compliance dashboards for regulatory audits.
Yes. Zentixs Saga supports multi-site, multi-location, and multi-department archival operations with centralized control and local access management.
Zentixs Saga improves compliance, reduces manual errors, enhances data security, speeds up retrieval, and ensures complete lifecycle control of archived records.