Computerized Systems Validation and Data Integrity

The Brief

Tixel, by Novoxel, sells medical equipment based on its Thermo-Mechanical Action technology to dermatology and aesthetics markets worldwide. Its quality platforms, software infrastructure and manufacturing tools needed a risk-based validation framework aligned with FDA 21 CFR Part 11, EU Annex 11 and ISO 13485.

What We Do

• Planning and risk: risk-based validation plans and software risk assessments under GAMP 5, defining the test boundaries.
• Specifications and traceability: URS, FS and traceability matrices linking each regulatory requirement to a system feature.
• Qualification: IQ, OQ and PQ protocols and execution - electronic records and signatures, security levels, disaster recovery and audit trails.
• Maintenance: change control procedures and Validation Summary Reports to keep the systems audit-ready.

Result

Validated, audit-ready computerized systems supporting Tixel’s growth in international markets.