Built to Last: How to Implement True GxP-Ready Long-Term Archiving

Insights from Vincent Dubois at BioTechX Europe 2025

In the life sciences and pharmaceutical industries, long-term data preservation is no longer optional—it is a regulatory expectation and a foundational element of digital trust. 

At BioTechX 2025 in Basel, Vincent Dubois delivered a powerful and highly practical session titled “Built to Last: GxP-Ready Archiving”, emphasizing what regulated organizations must do today to future-proof their scientific, clinical, and manufacturing data.

Watch the full presentation here:

This article summarizes the key messages and recommended actions from his talk, based entirely on the provided presentation slides. 

Why Long-Term Archiving Matters in GxP

Preserving Integrity, Readability, and Trust Over Decades

Life sciences organizations generate vast volumes of dynamic digital information—from QC data to audit trails and clinical documentation. Vincent Dubois emphasized a regulatory shift: backups cannot replace archives.

Backups restore operational systems, but archives must prove authenticity, integrity, traceability, and readability over decades. This distinction is foundational and reflected in upcoming regulatory frameworks such as EU Annex 11 (draft 2025) and EMA 2023 computerized systems guidance. 

Regulators increasingly demand:

•    Read-only archives
•    Integrity validation during migrations
•    Audit trail preservation
•    Retrieval with search/sort capabilities
•    Physically and logically separate backups of archives

Data Governance Before Technology

Why Policies and Roles Must Come Before Infrastructure

A central message in Vincent’s talk: technology alone cannot guarantee compliant preservation.

Quoting Dr. David Marco:
“Data governance is the discipline of making sure the right people have the right data, of the right quality, at the right time, for the right reasons.” 

Without clear policies, retention rules, and exit plans, organizations risk non-compliance—even with high-quality systems. Good governance defines how data is created, validated, preserved, accessed, migrated, and retired.

Five Challenges Every GxP Organization Will Face

Understanding the Core Risks in Long-Term Preservation

Vincent outlines five unavoidable challenges in implementing or operating an electronic long-term archive:

1. “Snapshot ≠ Archive”
The Loss of Audit Trails and Investigative Capability

System snapshots restore environments but fail to preserve required metadata:
•    Audit trails
•    Search/sort functions
•    Contextual metadata
These omissions make snapshots non-compliant for regulated archiving. 

2. Vendor Lock-In and Missing Exit Plans
The Danger of Proprietary Formats

Many organizations lack migration strategies, making them dependent on specific vendors or outdated technologies. Vincent stresses the importance of:
•    Portable preservation formats
•    Contractual exit plans
•    Migration playbooks

3. Key Management Across Decades
Ensuring Long-Term Accessibility to Encrypted Data

Encryption keys must remain accessible even 10–30 years later. This requires:
•    Regular key rotation
•    Escrow
•    Durable trusted storage
•    Documentation of access procedures

4. Proving Integrity After Migration
Verifiable, Documented Data Authenticity

Regulatory expectations require demonstrable technical integrity, including:
•    Pre- and post-migration checksums
•    Signed manifests
•    Immutable audit records
These measures ensure that no data is lost or altered during transfers. 

5. Balancing Costs and Retrieval Needs
Optimizing Storage Without Compromising Compliance

Not all archives need fast retrieval. Vincent highlights the importance of matching:
•    Storage cost and durability
•    SLA commitments
•    Retrieval frequency
A tiered architecture often provides the best balance.

Backups ≠ Archiving

Understanding Distinct Regulatory Roles

Vincent underscores a core regulatory message: “Backups restore. Archives prove.”

Backups are optimized for RTO/RPO, while archives must deliver:
•    Read-only immutability
•    Complete metadata
•    Audit trails
•    Integrity hashes
•    Long-term readability
•    Segregated backup copies

The MHRA is explicit: “Backups don’t replace long-term archiving.” 

Choosing the Right Infrastructure: On-Prem, Cloud, or Hybrid?

Strategic Considerations for Durable GxP Archiving

Vincent compares three models:

1. Cloud Archiving
High Durability and Built-In Immutability

Advantages include:
•    WORM enablement (AWS S3 Object Lock, Azure Immutable Blob, GCP Object/Bucket Lock)
•    Built-in durability
•    Simplified access control

Key considerations:
•    IAM
•    Audit logs
•    Egress costs
•    Vendor exit strategy

2. On-Prem Archiving
Maximum Local Control but Higher Maintenance Burden

Benefits:
•    Full data locality
•    Independence from cloud providers

Challenges:
•    CAPEX
•    Hardware refresh cycles
•    Obsolescence risk

3. Hybrid Archiving
Often the Most Balanced Model for GxP Requirements

This model uses:
•    Cloud for durable immutable storage
•    On-prem for viewers, workflows, and sensitive processing
Hybrid architectures reduce modernization costs while enabling controlled local data flows.

A Practical 90-Day Plan to Get Started

Vincent’s Roadmap for Immediate Action

Vincent proposes a focused, achievable 90-day plan:

Step 1 – Approve a Preservation Policy
Define Formats, Retention, and Access Rules

A compliant policy should be:
•    OAIS-aligned
•    ALCOA+/FAIR-aware
•    Specific on data types and format rules

Step 2 – Enable Immutability and Segregated Backups
Implement WORM and Validate Restore Processes

Actions include:
•    Enabling WORM
•    Creating logically and physically separate archive backups
•    Performing restore and migration tests

Step 3 – Pilot a Migration
Prove Your End-to-End Archiving Process

Run a controlled migration that includes:
•    Data
•    Metadata
•    Audit trail
•    Pre/post checksums
•    Retrieval with search/sort demonstration
This pilot builds internal capability and regulatory confidence. 

How Watcher 4.0 Enhances GxP-Ready Archiving

Automating Compliance and Ensuring Long-Term Data Integrity

biomedion’s Watcher platform plays a central role in enabling GxP-ready archiving by providing:

•    Automated capture of data, metadata, and audit trails
•    Immutable, compliant archiving workflows
•    Integrity verification through hashing and manifest control
•    Support for standardized, portable preservation formats
•    Scalable integration across cloud, on-prem, and hybrid ecosystems

As organizations modernize their archiving strategies, Watcher 4.0 ensures end-to-end compliance across the entire data lifecycle.

Discover how Watcher 4.0 can transform your laboratory’s data management – ensuring compliance, security, and efficiency every step of the way.

Learn more

Conclusion: Build for Durability, Not Convenience

Future-Proofing Your Regulatory Data Landscape

Vincent Dubois’ session at BioTechX 2025 delivers a clear message:
Long-term archiving must ensure trustworthy, immutable, retrievable data that survives decades of technological change.

Organizations that act now—strengthening governance, enabling immutability, piloting migrations, and leveraging solutions like Watcher—will be ready for the next generation of regulatory expectations.

References and Further Reading: