Seamless, Automated Archiving

Archive data automatically and continuously while ensuring compliance with legal and regulatory requirements, including ALCOA+ guidelines. Watcher 4.0's intelligent agents monitor your laboratory instruments and systems, capturing data at the point of creation without disrupting your workflows.

Searchable and AI-Ready Archive

Leverage metadata-enriched archives for effortless search and retrieval, enabling FAIR-compliant (Findable, Accessible, Interoperable, Reusable) data that's ready for AI training. Transform your archived data into a strategic asset that drives innovation and accelerates discovery.

Reporting and Audit Trails

Streamline workflows, focus your team on core activities, and achieve meaningful reporting with reduced manual effort and robust audit trails. Every action is tracked and documented, ensuring complete traceability and inspection readiness.

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Compliance F.A.I.R / ALCOA+

Watcher 4.0 fulfills the F.A.I.R & ALCOA+ principles by design. Our platform ensures data integrity throughout the entire lifecycle, from capture to retirement, meeting the strictest regulatory requirements for FDA, EMA, and OECD-GLP compliance.

Flexible Deployment Options

Watcher 4.0's hybrid archiving functionality for On-Premise and Cloud deployment offers the flexibility to archive data according to your infrastructure needs, significantly reducing the total cost of ownership for long-term archiving while maintaining security and compliance.

AI and Analytics Enablement

By adhering to the F.A.I.R principles, customers can leverage processed data in Watcher 4.0 for training AI models. Unlock greater value from your generated data through predictive analytics, pattern recognition, and data-driven decision making.

User-Centric Design

Easy and scalable configuration of agents to monitor laboratory devices. Reduce efforts to find data through intelligent tagging with relevant metadata. Ensure complete traceability of all data to specific projects, studies, or experiments.

Workflow Management

Starting pre defined Workflows through montoring processes on lab Instruments to e.g. Approve the archiving of Instrument data.

The exponential growth of data generated by analytical instruments, laboratory systems, and electronic documentation requires a solution that ensures traceability, integrity, and regulatory compliance. 

Watcher 4.0 delivers exactly that: a powerful platform for reliable long-term archiving of raw data, measurement protocols, and audit trails – fully compliant with GxP, FDA, EMA, and OECD-GLP standards. 

The Role of Watcher 4.0 in Modern Laboratories 

  • Watcher 4.0 identifies, collects, and structures all relevant laboratory data. From spectra and chromatograms to metadata and device configurations – Watcher 4.0 ensures secure, immutable, and searchable storage of critical data. 
  • Without such an archiving solution, laboratories risk data loss, lack of traceability, or even regulatory findings during inspections by authorities such as the EMA or FDA. 

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 Our Watcher Longterm Archiving Solutions 

healthcare (1)

What is biomedion Watcher 4.0, and who is it designed for?

biomedion Watcher 4.0 is a next-generation platform for GxP-compliant long-term scientific data archiving. It is purpose-built for modern laboratory environments that require scalable, secure, and fully contextualized data storage over decades. Watcher 4.0 is particularly suited for greenfield projects, cloud-first strategies, decentralized data capture, and organizations seeking passive-first, validation-light, or hybrid deployment models. 

 

 

Which compliance standards does Watcher 4.0 meet, and how does it ensure data integrity?

Watcher 4.0 is fully aligned with global regulatory frameworks, including FDA 21 CFR Part 11, EMA, OECD GLP, and industry best practices. It is designed around the ALCOA+ principles, ensuring that archived data is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available. Furthermore, biomedion is ISO 9001:2015 certified, reflecting its commitment to quality and regulatory compliance. Watcher 4.0 protects data integrity, patient safety, and product quality across the entire data lifecycle.

 

What are the key advantages of Watcher 4.0?

Watcher 4.0 offers multiple advantages over previous generations and legacy backup systems:

  • Passive, non-invasive archiving that does not interfere with live operations.
  • Minimized validation effort (CSV-ready) due to simplified deployment and configuration.
  • Modern microservice architecture for scalability, flexibility, and cloud-readiness.
  • Self-service UI/UX designed for intuitive user interaction.
  • Out-of-the-box audit trail indexing and full versioning for comprehensive data history.
  • Advanced SSO integration for centralized access control.
    Unlike traditional backup tools focused on disaster recovery, Watcher 4.0 is a regulatory-grade long-term data archiving solution, purpose-built to support regulatory inspections, audits, and lifecycle data governance.

 

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What is biomedion Watcher 2.x, and who is it designed for?

biomedion Watcher 2.x is a proven and established platform for GxP-compliant long-term archiving of scientific data. Nicknamed “The Proven Classic,” it is particularly suited for mature, validated laboratory environments that rely on deep system integration, custom APIs, and windream-based workflows. biomedion continues to fully support Watcher 2.x as a stable, compliant solution for customers with specific long-term infrastructure needs.

 

 

How does Watcher 2.x ensure GxP compliance and what role does ALCOA+ play?

Watcher 2.x fully complies with regulatory standards such as FDA 21 CFR Part 11, EMA, and OECD GLP. Both Watcher 2.x and Watcher 4.0 implement ALCOA+ principles, ensuring data is Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available. This ensures data integrity throughout its entire lifecycle. Furthermore, biomedion GmbH is ISO 9001:2015 certified for delivering validated on-premises and cloud-based data archiving services, supporting secure storage and compliant access to raw scientific data.

 

What are the main benefits of Watcher 2.x as a long-established archiving solution?

Watcher 2.x offers:

  • Decades of reliable operation in highly regulated laboratories.
  • Seamless integration into existing infrastructures.
  • Full control over data acquisition via APIs.
  • Complete integration with windream ECM.
  • A cost-effective validation pathway as GAMP5-compliant configurable standard software.
  • An intuitive Windows Explorer interface, minimizing training needs while maintaining full audit trail functionality.

 

 

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