Commissioning, Qualification & Validation (CQV)
We bridge strategy and execution ensuring it meets the highest international GMP standards.
Proven Leadership in CQV
Zyme Biotech is recognised for its hands-on expertise in Commissioning, Qualification & Validation across multiple facility types, including biologics, cell and gene therapy, aseptic manufacturing, and high-containment laboratories. Our CQV programs are built on regulatory alignment, scientific rigor, and risk-based principles — ensuring every project achieves compliance efficiently and sustainably.
End-to-End CQV Delivery
We manage the complete CQV lifecycle, from concept through sustained operation. Our approach aligns with ICH Q9, ASTM E2500, and ISPE Good Practice Guides, delivering a balance of compliance assurance and operational practicality.
Commissioning & Start-Up
We oversee system commissioning to verify design intent, functionality, and performance.
Our engineers and validation specialists work collaboratively to ensure seamless integration between construction turnover, commissioning, and qualification.
Computer System Validation (CSV)
We validate software and computerized systems according to GAMP 5 and global data integrity requirements.
Our CSV expertise covers MES, LIMS, BMS, PLCs, and other critical systems ensuring compliance with 21 CFR Part 11 and Annex 11.
Process & Cleaning Validation
Zyme Biotech supports product and process validation through lifecycle-based strategies.
We develop and execute protocols for process validation (PV), cleaning validation, and continued process verification (CPV) ensuring consistent quality and reproducibility.
Digital Validation Implementation
Through our partnership with ValGenesis, we deliver digital validation lifecycle management systems (VLMS) that replace manual documentation with secure, compliant electronic workflows — improving traceability, data integrity, and cycle times.
