Biotech: Cloud LIMS Migration with Data Migration and Interface Controls
What we succeed?
As a result of the partnership we established with Validfor, testing, approvals, documentation and repository in one platform and full visibility, traceability and audit rediness.
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The Problem
High-Risk Data Integrity Gaps During On-Premise to Cloud LIMS Transition
A biotech company transitions from an on-premise LIMS to a cloud LIMS integrated with laboratory instruments and ELN — introducing high data integrity risk, high migration risk, and medium interface risk across the platform.
High DI risk — test results directly affect product release decisions
High migration risk during transition from on-prem to cloud LIMS
Medium interface risk across instrument-to-LIMS and ELN integrations
No validated data migration or interface control coverage in legacy system
The Strategy
Risk-Based Validation Covering Migration Integrity, Interfaces, and Audit Trails
The validation scope was defined across data migration integrity, instrument interfaces, audit trails and metadata, user roles, backup/restore, and reporting — prioritised according to the high DI and migration risk profile of the transition.
Migration verification: record count reconciliation, sampling, and value/meaning checks
Interface testing: instrument → LIMS data flow, confirming no truncation or unit conversion errors
Audit trail tests covering result modifications and approval workflows
User role and backup/restore validation included in scope
Validfor is an outstanding solution for managing the software validation life cycle. It brings structure and clarity to the entire validation process.
Luca Termite
IT Project Manager
Validfor is an outstanding solution for managing the software validation life cycle. It brings structure and clarity to the entire validation process.
Luca Termite
IT Project Manager
The Solution
Validated Cloud LIMS Delivering Data Integrity Across Migration and Interfaces
The validated system ensures that all migrated data retains its original meaning and value, instrument interfaces pass data without truncation or conversion errors, and critical manual entries are protected by additional accuracy controls — meeting GMP release decision requirements.
Migrated data retains meaning and value; discrepancies investigated and closed
Critical data entry protected by additional accuracy checks when manual entry is used
Instrument-to-LIMS interface confirmed free of data truncation or unit conversion errors
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