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GxP Compliant Archiving
Docbyte Vault – Long Term Archiving in GxP Environments
From clinical trial data to retired systems – certified, audit-ready preservation for 30+ years.
Why Pharma Needs a Qualified Archiving Solution for Long-Term Archiving of GxP-Relevant Records
Pharmaceutical companies generate vast amounts of GxP-relevant data that must remain authentic, legible and accessible for decades. Whether from completed clinical trials, lab systems, or retired computerised platforms, long-term preservation must comply with ALCOA++ principles, GCP, EU Annex 11, and the new eIDAS 2.0 regulation on Qualified Electronic Archiving.
Docbyte Vault ensures your data remains intact, validated, and inspection-ready – without added validation burdens.
What is Docbyte Vault?
Docbyte Vault is a cloud-native archiving platform purpose-built for long-term preservation of GxP-relevant records, including data from completed clinical trials, eTMF systems, and retired computerised systems. It addresses all essential functional and technical requirements of Good Clinical Practice (GCP/GxP) digital archiving, ensuring long-term integrity, accessibility, and audit readiness.
With Docbyte Vault you don’t just store documents, you preserve trust. You don’t just archive, you create evidence.
The Gold Standard for Archiving in the Pharmaceutical Industry
Docbyte Vault ensures your data remains intact, validated, and inspection-ready – without added validation burdens.
Docbyte Vault at a Glance
ALCOA++ integrity enforcement
Retention & legal hold automation
Immutable audit trails that cannot be disabled
Role- and attribute-based access control
Restricted Inspector View (Vault Explorer)
Post-quantum secure evidence chaining
Metadata standards (OAIS / e ARK SIP)
Redundant, high-durability AWS storage
Use Cases
Long-term archiving of completed clinical trial data
Retirement of computerised systems with GxP relevance
Preservation of validation packages, SOPs, audit records
Retention of regulatory submission documents (eCTD, eTMF)
Platform Capabilities
Docbyte Vault is a Qualified Electronic Archiving (QeA) service, pre-certified under eIDAS 2.0.
Fully aligned with ISO 14721 (OAIS), ISO 14641, ISO 15801, ETSI TS 119.401 / 119.511 / 119.512
Evidence chaining (RFC 4998), qualified timestamps, and cryptographic fixity via SHA‑256
Encryption using ECC_NIST_P521 to support post‑quantum resilience
Storage with 11-nines durability and optional multi-region setups
Format and metadata preservation using e‑ARK SIP structure
Integration-ready and audit-trail preserving APIs
Visit the Docbyte Trust Center for additional information about Docbyte certifications and compliance.
Meets GCP Requirements
How Docbyte Vault Meets GCP Requirements
Docbyte Vault is the perfect match for any GCP digital archiving requirement. It provides a robust, certified, and auditable archiving platform that ensures eTMF evidence integrity, legal defensibility, audit readiness, and secure long-term accessibility.
Integrity and Accessibility
- Supports full alignment with ALCOA++ (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available, Traceable).
- Software-enforced immutability via SHA-256 fixity checks, RFC 4998 evidence records, qualified timestamps.
- Full audit trails capturing all actions (ingest, access, modifications, deletions), non-disablable and retained even after user account deletion.
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Retention and Legal Hold
- Administrators define retention schedules per document type (eTMF, study documents) with automated enforcement.
- Legal hold functionality suspends deletion policies as required for audits or legal proceedings.
- Docbyte Vault enables retention even when the retention period is undefined or indefinite, ensuring compliance with ICH rules and evolving GxP expectations.
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Disaster Recovery and Business Continuity
- Deployed on AWS with multi-region or sovereign cloud options; redundant data storage ensures high availability.
- Disaster recovery plan and architectural resilience support business continuity.
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Access Control
- Role-Based (RBAC) and Attribute-Based (ABAC) access control.
- Vault Explorer provides inspectors (“Explorers”) with limited, time-bound, read-only access to documents and business metadata—shielding technical or preservation data.
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Audit Trails
- Immutable logs capture all lifecycle events with user identity and timestamp. Audit trails cannot be disabled.
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Certification and Compliance
- Qualified Trust Service Provider (QTSP) for Qualified Electronic Archiving (QeA).
- Qualified Preservation of Qualified Electronic Signatures and Seals.
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Archive Storage
- Uses storage with versioning; durability rated 11-nines.
- Immutability is enforced at the application layer (evidence chaining, fixity checking).
- Post-quantum encryption supported via ECC_NIST_P521.
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Metadata and Format Preservation
- e-ARK SIP format ingestion and OAIS-based package structure, including sub-packages, descriptive and technical metadata.
- Fixity revalidation, virus scanning, format conversion and metadata enrichment during ingest.
- Beyond archiving, Docbyte Vault enables digital transformation: secure data environments, external information sharing, and AI-ready classification tools.
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Search and Retrieval
- Full-text and metadata search across packages. Reports and exportable search collections supported.
- Collections can be shared to specific users or groups with Vault Explorer visibility.
- Docbyte Vault can ingest records from a wide range of source systems.
- OpenAPI and OpenSearch.
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Standards Compliance
- Compliant with ISO 14721 (OAIS), ISO 14641, ISO 15801, ETSI TS 119.511/.512, eIDAS 2 and EU Regulations.
- Qualified Electronic Archiving service under Belgian Digital Act and in accordance with eIDAS Regulation (EU) 2024/1183.
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What Pharma Teams Ask Us
Is Docbyte Vault validated for GxP archiving?
Yes. We are a Qualified Trust Service Provider and provide IQ/OQ documentation, validation scripts and SOP templates.
Can inspectors see only what they need?
Yes. Vault Explorer restricts inspector access to business metadata and selected documents, with time-bound access.
What if our archive grows to petabytes?
Scalability is built-in. Our cloud-native architecture supports high growth without disruption.
Can we apply custom retention policies?
Yes. Retention periods are configurable by document type, aligned to your SOPs and regulatory requirements.
What happens when storage infrastructure changes?
We maintain portability through standards. All metadata and content can be exported and validated externally.
Can we migrate formats in the future?
Yes. Docbyte Vault supports representation management – allowing format updates while preserving originals.
How is data protected over 30+ years?
Application-layer immutability (not relying solely on S3 WORM), cryptographic timestamping, and integrity checks.
Coming Soon
Download our whitepaper with full regulatory mapping, architecture, use case validations, and implementation best practices.
Secure, Scalable, and Ready for the Future
Pharmaceutical compliance software demands more than basic archiving. Docbyte Vault platform is scalable to meet the needs of organizations of all sizes, from clinical trial archiving to pharmacy compliance. With a user-friendly interface, advanced security measures, and long-term preservation features, we ensure your pharmaceutical data is safeguarded for the future.
Contact us today to discuss your archiving strategy and receive a tailored demo or technical overview.
