Watcher 2.x

Watcher 2.x is Biomedion's proven, on-premises platform for GxP-compliant long-term data archiving, purpose-built for regulated laboratory environments where infrastructure sovereignty, validated stability, and deep system integration are strategic priorities. As a core Biomedion platform, Watcher 2.x is actively maintained and supported, ensuring full compliance with international regulations including FDA 21 CFR Part 11, EU Annex 11, EMA, and OECD GLP, while implementing ALCOA+ principles for data integrity and providing immutable storage for audit-ready archiving.

Watcher 2.x addresses the most pressing challenges faced by GxP organisations: audit pressure from legacy systems lacking proper audit trails, high manual effort in data retrieval, data silos that prevent interoperability and FAIR-compliant data reuse, and the business risks associated with non-digital or poorly structured archives. By centralising and automating the archiving process, Watcher 2.x reduces compliance risk, accelerates audit preparation, and lays the groundwork for AI-readiness and analytics.

Core Data Acquisition and Archiving Capabilities

• Active data acquisition via the BM-Watcher Agent, which monitors laboratory instrument file systems, automatically detects new or modified files, and creates new file versions without interfering with ongoing processes
• Seamless integration with the windream ECM platform, including its Transfer Module, enabling fine-grained control over which data is archived
• Passive data capture technology that monitors defined data sources without disrupting laboratory workflows
• Direct integration with laboratory instruments and software systems for active data capture
• Automated data capturing via virtual drives in Windows Explorer, minimising user training requirements
• Full versioning and data lifecycle documentation with comprehensive audit trail functionality
• Intelligent archiving policies managing data from hot storage for active projects to cost-effective cold storage for long-term retention, supporting retention periods of 10, 25, or even 50 years

Metadata Automation and Enrichment

• Fully rule-based, automatic metadata enrichment that transforms metadata creation from a manual bottleneck into a seamless part of the archiving process
• Content-based metadata extraction from PDF, TXT, and any text-readable file formats — automatically identifying relevant terms, identifiers, parameters, and labels
• Rule-based metadata extraction directly from filenames, ensuring consistent classification without manual effort when files follow logical naming conventions
• Contextual metadata assignment based on directory structures, project folders, and repository paths, ensuring data is correctly classified from the moment it enters the archive
• Metadata enrichment from proprietary databases and external text files, providing deep contextual information for every archived record
• Accelerated audit preparation and improved data discoverability through automated metadata depth

Compliance and Data Integrity Features

• Full compliance with FDA 21 CFR Part 11, including electronic signature and audit trail capabilities
• Meets all requirements for computerised systems under EU Annex 11
• Designed as configurable GAMP 5-compliant standard software for efficient validation with minimal CSV requirements
• Comprehensive audit trail excellence with fast, indexed audit trail search and advanced filtering
• Complete context traceability capturing who generated data, which instrument was used, conditions of generation, whether modifications occurred, and whether digital signatures were applied
• Every data modification logged with comprehensive audit trails supporting full traceability throughout the data lifecycle

Security and Access Control

• Full SSO integration for centralised access control
• Role-based permissions and detailed access logging
• Encryption at rest and in transit
• Support for modern authentication protocols including SAML, OAuth, and LDAP for seamless integration with existing security infrastructure

Key Reasons to Choose Watcher 2.x

• Reliable operation — decades of proven use in regulated laboratory environments
• Deep integration — with existing laboratory systems and the windream ECM platform
• Full control — over data archiving, data lifecycle management, and automated data capturing
• Proven stability — in on-premises deployment models

Considerations and Known Limitations

• Higher validation efforts required due to system-level integrations
• Designed primarily for on-premises deployment; not suited for cloud-native environments
• Supports active data acquisition only — no passive data acquisition functionality
• Less flexible user interface and administration compared to newer platforms
• Limited built-in revision history (versioning available via database optimisations)
• Centralised authentication limited to Windows Active Directory
• Operates on a monolithic architecture with dedicated notification and escalation tools

Latest Release and Roadmap (Q4 2024 and Beyond)

• Enhanced error recovery for archiving workflows via Workflow Step Flagging
• Improved reporting with unit types
• Full compatibility with windream Server 8.0
• Centralised Server Escalation Service (SEC) for enhanced error handling
• Optimised audit trail search performance through enhanced indexing
• Enhanced TLS-based notification security
• Bulk Update Tool (BUT) to streamline component updates
• SMB Copy in Archiving for higher data transfer performance
• Planned releases in February 2025, July 2025, and December 2025, with support firmly planned beyond 2027

Watcher 2.x is deployed exclusively on-premises and is designed to coexist with legacy archiving platforms, offering migration tools and compatibility layers to ensure business continuity during transitions. It is fully validated as GAMP 5-compliant standard software and integrates deeply with the BM-windream ECM ecosystem, making it the preferred choice for organisations requiring customised, stable, and compliance-driven laboratory data archiving with long-term vendor support.