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A BIOMEDION PRODUCT

Next Generation Architecture for GxP Life Sciences Data Management

Watcher 4.0 is your trusted platform for scientific data in healthcare, medical research, and pharmaceutical development. Built on cutting-edge microservice architecture, Watcher 4.0 maintains an intelligent GxP data supply chain from the very first bit until long-term archiving, ensuring compliance with USFDA and EU Annex 11 regulations while enabling unprecedented scalability and flexibility.

Typical problems a GxP-Company
face in Archiving

Audit Pressure, Compliance & Integritiy

Audit Pressure, Compliance &
Data Integrity

The headline and subheader tells us what you're offering, and the form header closes the deal. Over here you can explain why your offer is so great it's worth filling out a form for.

 

High Manual Effort & Inefficiency

High Manual
Effort &
Inefficiency

Data retrieval is slow, errorprone and resource-intensive; valuable time is wasted in audits and projects instead of focusing on science.

 

Data Silos & Lack of Inoperability

Data Silos &
Lack of 
Interoperability

Systems are disconnected; data is scattered across labs, file shares and archives. No FAIR principles, no holistic view, no reuse for AI or analytics.

 

 

Cost & Business Risk

Cost &
Business Risk

Non-digital data storage causes high costs for physical maintenance and Manual searching. Missing metadata- and automation make data hard to find and reuse, prevent
AI-readiness, and increase the risk of compliance findings and reputational damage.

Watcher 4.0 -
the GxP-Archiving Solution

Wacther 4.0 logo

Full GxP Compliance & Data Integrity

Centralized, FAIR- Compliant
Archive

Instant Audit-Readiness

No More Data Silos

Efficiency & Cost Savings

Future-Proof & Vendor Independent

AI-Ready: Unlock Legacy Data Value

Scalable for Growth & Expansion

A Revolutionary Approach to Data Archiving

Watcher 4.0 represents a paradigm shift in how life sciences organizations manage their data. Unlike traditional monolithic systems, our microservice-based architecture provides the agility and scalability needed for modern laboratories. The platform offers both passive and active data capture capabilities, allowing seamless integration with existing infrastructure while preparing your organization for future technological advances.

Key Architecture Benefits

Desiged for Longterm GxP Archiving

Microservice-Based Design

Independent, scalable services that can be updated without system-wide impact

Architecture of Lomgterm GxP Archiving

Cloud-Native Architecture

Built for hybrid and cloud deployments from the ground up

Connecivity and Integration of GxP longterm archiving

API-First Approach

Comprehensive REST APIs for seamless integration with laboratory ecosystems

DevOps for longterm GxP archiving

Container Ready

Kubernetes-compatible for modern DevOps practices

Core Capabilities

Comprehensive Features for Complete Data Lifecycle Management
Data Capture and Ingestion of GxP Longterm Archiving

Data Capture & Ingestion

Watcher 4.0 identifies, collects, and structures relevant laboratory data including spectra, chromatograms, metadata, and device configurations. Our passive data capture technology monitors defined data sources without interfering with ongoing processes, while active capture enables direct integration with laboratory Instruments and software systems.

Context & Traceability wih Watcher 4.0

Context & Traceability

Beyond simple storage, Watcher 4.0 captures the complete context of your data: who generated it, which instrument was used, under what conditions, whether modifications occurred, and if digital signatures were applied. This comprehensive traceability is essential for quality assurance and regulatory audits.

Intelligent Longterm GxP Archiving

Intelligent Archiving

Automated policies manage data throughout its lifecycle, from hot storage for active projects to cost-effective cold storage for long-term retention. Watcher 4.0 ensures data remains accessible, readable, and verifiable throughout the entire Retention period, whether that‘s 10, 25, or even 50 years.

Compliance
and Validation

Watcher 4.0 provides comprehensive security features including full SSO integration for centralized access control, role-based permissions, encryption at rest and in transit, and detailed Access logging. The platform supports modern authentication protocols including SAML, OAuth, and LDAP, ensuring seamless Integration with your existing security infrastructure.

Compliance Features

Designed for regulatory Excellence

21 CFR Part 11 Compliant
Full electronic signature and audit trail capabilities

EU Annex 11 Ready
Meets all requirements for computerized systems

GAMP 5 Aligned
Designed for efficient validation with minimal CSV requirements

Audit Trail Excellence
Fast, indexed audit trail search with comprehensive filtering

Enterprise-grade Security and Governance

Security and Access
Control

Watcher 4.0 provides comprehensive security features including full SSO integration for centralized access control, role-based permissions, encryption at rest and in transit, and detailed Access logging. The platform supports modern authentication protocols including SAML, OAuth, and LDAP, ensuring seamless Integration with your existing security infrastructure.

Security and Access Controls with Watcher 4.0
a biomedion product

Next-Generation Architecture for Life Sciences Data Management

Smooth transition from
legacy systems

Migration and Compatibility

We understand that many organizations have existing Iivestments in data archiving systems. Watcher 4.0 is designed to coexist with legacy platforms, offering migration tools and compatibility layers that ensure business continuity while you transition to next-generation capabilities at your own pace.

Contact us for a consultation or request detailed feature comparison today!

Why Watcher 4.0 is valuable for
pharma customers

 

 

Commonly asked questions

What is Watcher 4.0 and what is it used for?

Watcher 4.0 is a modern data archiving platform designed for regulated environments in Life Sciences, Biotechnology, and the Pharmaceutical industry.
It enables long-term, compliant, and audit-ready preservation of data from laboratory information systems, analytical instruments, or production environments.
Watcher 4.0 ensures that scientific data remain traceable, secure, and inspection-ready — regardless of their original source system.

How does Watcher 4.0 differ from Watcher 2.x?

Watcher 4.0 is the next-generation of Biomedion’s archiving solution — completely redesigned for cloud and hybrid infrastructures.
While Watcher 2.0 was primarily developed for on-premise environments, Watcher 4.0 offers:

  • a modular, web-based architecture,
  • FAIR-compliant data management (Findable, Accessible, Interoperable, Reusable),
  • integrated AI-assisted search and analytics,
  • and simplified validation and integration into modern IT ecosystems.

Watcher 4.0 is more than an archive — it is a data intelligence hub that brings historical laboratory and production data into the future.

Which systems and file formats can Watcher 4.0 archive?

Watcher 4.0 supports a wide range of systems and formats, including:

  • Chromatography and spectroscopy systems (e.g., Empower, ChemStation, LabSolutions) or Stand-alone
  • LIMS, ELN, LES, CDS, and DMS systems
  • Standard file types such as PDF/A, XML, CSV, JSON, TIFF, ZIP, TXT
  • As well as proprietary instrument and raw data formats from analytical laboratories

Through standardized connectors and open APIs, Watcher 4.0 can be flexibly integrated into existing environments, enabling automated and context-rich data archiving.

How does Watcher 4.0 support AI-driven data analysis?

Watcher 4.0 does not yet include active AI functionality — but it has been purpose-built to enable it in the future.
By enriching all archived content with detailed metadata and contextual information, Watcher 4.0 lays the groundwork for powerful AI-based search and analysis capabilities to be added later on.

This means that when AI modules are introduced, they will be able to access well-structured, semantically rich data — making future AI-assisted querying, pattern recognition, and trend analysis far more accurate and reliable.
In other words, Watcher 4.0 already provides the data architecture and FAIR framework needed to unlock intelligent insights later, once AI features become available.

Can archived data be exported or migrated again?

Yes. Watcher 4.0 offers open interfaces and standardized export functions that allow data to be re-exported at any time — for migration, reanalysis, or external audits.
All exports are fully documented and validated, ensuring that archived data remain traceable and verifiable even outside of Watcher 4.0.

Is there a REST API connection in Watcher 4.0?

Yes. Watcher 4.0 offers a modern REST API interface that enables seamless integration with external systems such as LIMS, ELN, CDS, DMS, and ERP platforms.
Through this API, data and metadata can be automatically transferred, archived, or retrieved, supporting automated workflows and system-to-system interoperability.

The REST API also makes it easier to connect Watcher 4.0 to future AI or analytics modules, since it allows structured access to all archived and metadata-enriched information.

 Embrace the power of Watcher 4.0 Today!

Unlock the Full Potential of Your Laboratory Data with Watcher 4.0: The Ultimate Solution for GxP Compliant Archiving