a biomedion product

GxP-compliant long-term data archiving

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—alongside our latest generation Watcher 4.0—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.


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 robust APIs and 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 BM-windream ECM platform ensures:

  • 21 CFR Part 11 compliance.
  • Cost-effective validation (as configurable GAMP5-compliant standard software).
  • Intuitive operation via virtual drives in Windows Explorer, minimizing user training efforts.
  • Full versioning and life-cycle documentation with audit trail functionality.


Advantages of Watcher 2.x

As “The Proven Classic”, Watcher 2.x delivers:

  • Decades of reliable operation in regulated laboratory environments.
  • Deep integration with existing laboratory systems and windream ECM.
  • Full control over data archiving via API-level integration.
  • 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 available via database optimizations).
  • Centralized authentication limited to Windows Active Directory.
  • Operates on a monolithic architecture with dedicated notification and escalation tools.

Watcher 2.x is ideal for organizations that require highly customized integrations, tight coupling with proprietary workflows, and mature, validated infrastructure.


Latest Release (Q4 2024)

The current release, Watcher 2.x Q4 2024 (December 13, 2024), 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.

For full release details, see:
📄 Watcher 2.x Feature Overview (PDF)
🔄 Migration Planning Guide (PDF)


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 remains a fully supported, validated, and production-ready solution for regulated environments where stability, deep system integration, and compliance take priority.

Not sure if Watcher 2.x is the right fit for your lab? 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 your detailed feature comparison today!




 

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