ELECTRONIC RECORDS ARCHIVING
Where Clinical Documents Live After the Trial Closes
GXP-Storageยฎ Electronic Records Archiving service delivers validated, integrity-verified, long-term storage for regulated electronic records, including eTMFs, study data, equipment and instrument data, batch records, and quality system documentation. That, combined with a SHA-256 chain-of-custody โ from transfer to archive โ and optional hybrid physical and digital custody on the GXP-Guardianยฎ platform, provides inspection confidence.
If Your Electronic Records Archive Canโt Verify, Unify, and Deliver, Itโs a Risk
When a clinical trial closes, sponsors and CROs face retention obligations that can extend 15 to 25 years or more. The electronic trial master file, study data packages, clinical reports, and supporting documentation must remain accessible, intact, and demonstrably unaltered โ ready for inspection on short notice.
For most organizations, that obligation is met by whatever infrastructure is available at study close: shared drives, retired servers, compressed archives on backup media. None of these satisfy the audit-readiness expectations regulatory inspectors bring to archive reviews. Hereโs where the problems usually present themselves:
Integrity is assumed, not verified. Files transferred via standard means arrive with no mathematical proof of completeness or tamper-evidence. Inspectors increasingly expect checksum verification.
Retrieval is reactive, not ready. When inspectors requestย records, organizations spend days locating, consolidating, and producing an archive that should be immediately accessible.
Digital and physical records are siloed. eTMF archives and physical trial materials are managed separately, creating reconciliation gaps at inspection.
Retention timelines outlive the systems. Archives placed in systems that are later decommissioned create chain-of-custody breaks that are difficult or impossible to reconstruct.
Validated Storage, Verified Integrity, Documented Chain-of-Custody
GXP-Storageโs Electronic Records Archiving Service follows a four-stage workflow from receipt of files to confirmed archive:
STAGE: Secure file transfer from CRO or sponsor via shared folder access or physical media. GXP-Storage coordinates the transfer logistics and confirms receipt.
HASH: Before upload, GXP-Storage generates a per-file SHA-256 manifest (CSV inventory of all files, sizes, and individual hashes) and a single archive-level SHA-256 fingerprint.
UPLOAD: Files are attached to a Virtual Container in GXP-Guardian โ the platformโs inventory record for the digital archive. The expected archive hash is recorded on the Container.
VERIFY: A PowerShell verification script re-computes the archive hash post-upload and confirms it matches the expected value. Any discrepancy is flagged immediately.
Strategic & Financial Value
Transform your fixed overhead into flexible, usage-based operating expenses that scale with your actual research pipeline – not worst-case capacity planning. Redirect capital and scientific talent toward core R&D innovation instead of managing storage infrastructure and compliance administration.
Technology & Operational Advantages
Access enterprise-grade chain-of-custody tracking, automated compliance reporting, and real-time inventory visibility through GXP-Guardian technology infrastructure that would require millions in capital investment to replicate internally. Scale instantly from hundreds to millions of samples without facility expansion, hiring, or long-term lease commitments – true elasticity matched to your development pipeline.
Competitive Positioning
Your competitors are already reallocating archive management costs toward pipeline advancement. Enable your organization to pivot quickly – expand, contract, or redirect research programs without being constrained by physical infrastructure decisions made years ago based on different strategic priorities.
Compliance by Design โ Not by Configuration
Our platform doesnโt just store recordsโit enforces the regulatory framework that makes them defensible at inspection.
- 21 CFR Part 11 โ GXP-Guardian is a validated system; archive records carry computer-generated, time-stamped audit trail on every field change
- EU Annex 11 ยง17 โ Archive records protected from deletion and alteration; retrievable within defined timeframe; platform validated annually
- ALCOA+ Enduring โ SHA-256 hashing provides multi-decade integrity evidence; archive package retrievable upon authorized request
- ALCOA+ Attributable โ Per-file manifest identifies every document; Virtual Container records who performed each action and when
- ICH E6(R3) โ Digital archive supports sponsor TMF retention obligations for the post-trial period as required by GCP
- 21 CFR Part 11 ยง11.10(e) โ Salesforce field history audit trail is computer-generated, time-stamped, and user-attributed on all Container record changes
Archives That Build Inspection Confidence
Electronic records archive stakeholders consistently emphasize specific deliverables to help ensure audit-readiness:
Inspection-ready Retrieval
Eliminates days-long scrambles to locate and produce archived records
SHA-256 Verification
Provides mathematical proof of integrity, replacing assumptions with evidence
Unified Physical and Digital Custody
Reduces vendor management overhead and audit complexity
Validated Platform
Eliminates the risk of chain-of-custody breaks when legacy systems are decommissioned
Quality Agreement & SOP documentation
Streamline vendor qualification and QMS integration
Physical and Digital Custody in One Archive
Post-trial regulatory obligations are not exclusively electronic. Physical retained samples, reference standards, investigational product accountability records, and paper source documents must be managed alongside the electronic records (eTMFs, study data, equipment and instrument data, batch records, quality system documentation) โ and both must be accessible at inspection.ย
GXP-Storage is the only archive provider that unifies physical and digital custody in a single GXP-Guardian record. The Virtual Container holding your eTMF digital archive can also link to physical materials stored in GXP-Storageโs purpose-built, controlled storage facilities โ creating a single inspection response point for everything associated with your study.
Key Capabilities
โข Single retrieval point: One system, one request, complete archive for any inspection scenario
โข Unified custody record: Transfer, storage, retrieval, and destruction captured in a single GXP-Guardian chain-of-custody
โข Cost consolidation: One vendor, one Quality Agreement, one audit, one archive fee structure
โข Simplified destruction: A single destruction record documents disposition of physical and digital materials when retention periods expire
Your Archive Is as Defensible as the Process That Built It
GXP-Storageโs electronic records archiving assessment reviews your post-trial archive obligations, current storage environment, transfer logistics, and physical material inventory to design an archive package that passes inspection โ not just stores files.
To learn more about Electronic Records Archiving, download our information sheet.