Pharma: Laboratory Instruments with Standalone Software (Hybrid Risks)
What we succeed?
As a result of the partnership we established with Validfor, our test cycles shrink from weeks to days through one structured digital workflow and standardized workflows and centralized validation knowledge
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The Problem
Hybrid Paper-Electronic Lab Systems Explicitly Vulnerable Without Defined Controls and Review
A laboratory uses instrument software producing electronic data supplemented by manual worksheets — creating a hybrid system that regulators explicitly call out as vulnerable when controls and review are weak. Without validated hybrid system SOPs, raw data retention controls, and second-person review, the completeness and integrity of lab records cannot be assured.
Hybrid systems explicitly identified as high-vulnerability when controls and review are weak
No validated SOP for reconciling paper and electronic record elements
Raw data and metadata retention not formally controlled or validated
Second-person review process undefined — reported outcomes not checked against raw entries
The Strategy
Hybrid System Validation with Defined SOPs, Second-Person Review, and Raw Data Controls
The validation scope covered hybrid system controls, raw data and metadata retention, second-person review, and audit trails — with instrument software validated for intended use and a hybrid system SOP defined to govern the reconciliation of paper and electronic records throughout the lab workflow.
Validate instrument software for intended use where required by risk assessment
Define hybrid system SOP for reconciling paper and electronic records
Implement review process that checks consistency of reported outcomes against raw entries
Establish raw data and metadata retention controls with audit trail coverage
Validfor offers unparalleled traceability and control, ensuring that computerized systems remain compliant with industry standards.
Gizem Bozok
Quality Area Manager
The Solution
Complete, Reconciled Lab Records with Verified Consistency Across Electronic and Paper Elements
Every complete lab record includes both electronic and paper elements, governed by a defined reconciliation and review process. Reported outcomes are verified against raw entries before sign-off — eliminating the hybrid system vulnerabilities that regulators specifically flag during inspection.
Complete record includes both electronic and paper elements with defined reconciliation and review
Reported outcomes verified against raw entries through an implemented second-person review process
Raw data and metadata retention validated and audit trail coverage confirmed
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