Equipment & System Validation

With more than 20 years of experience in building production lines, facilities and manufacturing sites – we offer our expert Validation services for the Pharmaceutical industry and the Medical Devices industry.  

 

 
Equipment
 
 
Our range of solutions provides you maximum flexibility. 
 
We offer external consulting Validation services in a variety of production site's areas of activity:
 
  • Certification of production facilities & equipment (clean rooms, warehouses, laboratories)
  • Writing framework documents, including: 
    • URS , BOD, VMP, Validation Policy
  • Writing protocols and reports for OQ, IQ, DQ PQ for critical systems
  • Routine support during certification, inspection and management of irregularities 
  • Validation consulting and services during controlled change in production lines, maintenance and live status updates 
  • Validation array's representative before Israeli and European authorities, and FDA, including preparation of documentation and   regulatory inspections