Data Integrity & Digital Systems
Controlled data lifecycle, computerized system governance, and audit-trail discipline for regulatory-facing biosafety and CMC testing.
Data integrity is part of the quality system, not an IT add-on
ALCOA+
HyQure applies ALCOA+ data integrity principles to support attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available records.
LIMS/EMS/ES
HyQure uses validated electronic systems and electronic signature controls to support complete, traceable, and efficient laboratory business processes.
- Validated, advanced electronic system
- Electronic Signature Management compliant with Part 11 and Annex 11 requirements
- Efficient business processes and complete data
- Real-time environmental parameter logging
- Audit trail.
Computerized system validation
HyQure manages computerized system validation with lifecycle documentation and risk-based verification aligned to intended use and GxP data expectations.
- System categorization assessment / GAMP system classification
- User Requirements Specification (URS)
- Functional Specification (FS) and Design Specification (DS)
- System Risk Assessment (RA)
- IQ/OQ/PQ
- Validation Summary Report (VSR)
- Standard Operating Procedures (SOPs).
Data Quality
HyQure applies data quality controls from laboratory review to QA review so records remain traceable, controlled, and review-ready.
- Account and access management
- Second-person review in laboratory
- Audit trail
- QA review
- Controlled distribution and receipt of records.
Data Security
HyQure protects electronic data and records with deletion-prevention, backup, recovery, and restoration-test controls.
- Deletion prevention controls (software-based)
- Periodic backup strategy
- Backup execution log
- Disaster recovery plan
- Backup restoration test.
Data lifecycle
Capture; review; approval; storage; retrieval; archival; backup.
Client value
Fewer avoidable data-integrity questions, clearer audit trails, better traceability, and stronger regulatory-facing confidence.
Competitive customer service angle
For international clients, the value is not only digital tools. The value is traceable testing data, controlled reports, audit-trail discipline, validated computerized systems, and faster supplier-qualification confidence.
Related HyQure services
Analytical Development & Validation
Plan a quality-driven testing package
Share product type, development phase, target market, sample type, method status, and expected report format. HyQure can help align scope, documentation, and timeline before project initiation.
Official regulatory reference links
- FDA 21 CFR Part 11
- EU GMP Annex 11
- MHRA GxP Data Integrity Guidance