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A biomedion product

GxP-compliant long-term data archiving -
on-premises

At biomedion, we recognize that every laboratory has its own unique requirements. While some organizations seek cutting-edge innovations, others value proven stability. That’s why we continue to support Watcher 2.x as one of our core platforms for GxP-compliant long-term data archiving.

Watcher 2.x is designed for organizations focused on on-premises infrastructure. Alongside our latest generation Watcher 4.0, it ensures full compliance with major international standards including FDA 21 CFR Part 11, EMA, and OECD GLP guidelines. Both solutions implement ALCOA+ principles for data integrity and provide immutable storage, while Biomedion GmbH maintains full certification under ISO 9001:2015 for both cloud and on-premises data archiving services.

 

Typical problems a GxP-Company
face in Archiving

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Audit Pressure, Compliance &
Data Integrity

Many legacy or file-based systems are not designed for OECD/FDA/EMA requirements; missing audit trails and incomplete metadata lead to inspection findings..

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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.

 

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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.

 

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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 2.x -
Trusted on-premises archiving solution

 

Logo Watcher 2.x

Full GxP Compliance & Data Integrity

Centralized, FAIR-Compliant Archive

Instant Audit-Readiness

No More Data Silos

Efficiency &
Cost Savings

Future-Proof & Vendor Independent

Proven GxP Solution

Scalable for Growth & Expansion

Core Features of Watcher 2.x

Watcher 2.x excels in active data acquisition, seamlessly integrating into existing laboratory infrastructures. Its design allows fine-grained control over which data is archived, using full integration with windream ECM, including its Transfer Module.

The BM-Watcher Agent monitors file systems of laboratory instruments, automatically detects new or modified files, creates new file versions, and enriches archived data with contextual metadata extracted from file paths, text files, or proprietary databases. Every data modification is logged with comprehensive audit trails, supporting full traceability throughout the data lifecycle.

The Power of Metadata with Watcher 2.x

Why it matters

Automated metadata enrichment drastically accelerates the classification process, reduces preparation time before audits, and makes data easier to search, retrieve, and evaluate than ever before. With the massive metadata depth that Watcher 2.x generates, your archived information becomes more discoverable, more valuable, and fully audit-ready.

Lifecycle_management

Automated Metadata Enrichment
in Watcher 2.x

Watcher 2.x delivers a new level of automation by enriching your files with metadata. Fully rule-based and completely automatic. This transforms metadata creation from a manual bottleneck into a seamless part of your archiving process.

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Metadata Extracted
Directly From the Content

The real breakthrough lies in Watcher’s ability to read and interpret content. Whether PDF, TXT, or any text-readable file, Watcher 2.x automatically extracts relevant terms, identifiers, parameters, or labels and turns them into metadata. This makes Watcher one of the most powerful automation tools for intelligent data organization.

metadata

Rule-Based Metadata From Filenames

When files follow logical naming conventions, Watcher 2.x can automatically extract and assign fixed metadata values directly from the filename. This ensures consistent classification without any manual effort.

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Metadata From
Folder Structures & Repository Paths

Watcher also analyzes where your data originates. Based on directory structures, project folders, or repository locations, it can automatically attach contextual metadata. Ensuring data is always classified correctly from the moment it enters the archive.

The BM-windream ECM platform ensures:

on-premises

On-premises

Designed to be implemented in your infrastructure

Validated

Fully Validated Software

As configurable GAMP5-compliant standard software

Capturing

Automated Data Capturing

Via virtual drives in Windows Explorer, minimizing user training efforts

Lifecycle Management

Data Lifecycle Management

Full versioning & lifecycle documentation with audit trail functionality

Core Capabilities

Comprehensive Features for Complete Data Lifecycle Management

Data Capture and Ingestion: Watcher 2.x

Data Capture and Ingestion

Watcher 2.0 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 Traceablity: Watcher 2.x

Context Traceability

Beyond simple storage, Watcher 2.0 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 Archiving: Watcher 2.x

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 2.0 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 2.x 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

Haken Bulletpoint21 CFR Part 11 Compliant
Full electronic signature and audit trail capabilities

Haken BulletpointEU Annex 11 Ready
Meets all requirements for computerized systems

Haken BulletpointGAMP 5 Aligned
Designed for efficient validation with minimal CSV requirements

Haken BulletpointAudit Trail Excellence
Fast, indexed audit trail search with comprehensive filtering

ENTERPRISE-GRADE SECURITY AND GOVERNANCE

Security and Access Control

Watcher 2.x 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 2.x
Migration and Compatibility with Watcher 2.x
Smooth transition from legacy systems

Migration and Compatibility

We understand that many organizations have existing Iivestments in data archiving systems. Watcher 2.x 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.

4 reasons why to choose Watcher 2.x

As "The Proven Classic", Watcher 2.x delivers:

Reliable

Reliable operation

Decades of reliable operation in regulated laboratory environments

Full integration

Deep integration

With existing laboratory systems and windream ECM

Full control

Full control

Over data archiving, data life-cycle, and automated data capruting

Stability

Proven stability

In on-premises deployment models

Considerations for Watcher 2.x

While Watcher 2.x remains a robust solution, there are specific aspects to consider:
  • Higher validation efforts due to system-level integrations
  • Designed primarily for on-premises deployment
  • No passive data acquisition functionality
  • Less flexible user interface and administration compared to newer platforms
  • Limited built in revision history
    (versioning avaiable via database optimizations)
  • Centralized authentication limited to Windows Active Directory
  • Operates on a monolithic architecture with dedicated notification and escalation tools
Current Release Watcher 2.x
Q4 2024 (December 13, 2024)

Latest Release
(Q4 2024)

The current release introduces numerous feature updates and enhancements:

  • Enhanced error recovery for archiving workflows
  • Improved reporting with Unit types
  • Full compatibility with windream Server 8.0
  • Centralized server escalation services (SEC)
  • Optimized audit trail search performance
  • Enhanced TLS-based notification security
Latest-Release
For full release details, see:

Roadmap and Continued Support

Our commitment to Watcher 2.x extends well into the future:

  • February 2025: Patch Release 1
  • July 2025: Watcher Q2 2025 Release
  • December 2025: Watcher Q4 2025 Release
  • Support beyond 2027 is firmly planned

Conclusion

Watcher 2.x is a fully supported, validated, and production-ready solution for regulated environments
where stability, deep system integration, and compliance have priority.

Not sure if Watcher 2.x is the
right fit for your company?

We are happy to discuss your current infrastructure, compliance obligations, and long-term data
management goals to help you make the best decision.

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

 Embrace the power of Watcher 2.x today!

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