Proficiency

Our engineers are hands on industry professionals with many years of experience in the areas of R&D, Engineering and Validation areas.

Their work, on both documentation and execution, has successfully passed regulatory agencies inspections.

Validation Services

synoptex consulting

Documentation


  • Validation Master Plan 
  • Development of Design documents  such as URS, FS, DQ, Traceability Matrix, Basis of Design, Validation Plan, and FAT/SAT Protocols
  • Develop and Execute 21 CFR Part 11 assessments for computerized systems
  • Support our clients with Data Integrity solutions and remediation plans 
  • Cycle development for sterilization and (VHP) processes 
  • Periodic re-qualification and Performance reviews 
  • Develope, refine and improve Standard Operating Procedures (SOP's) 
  • Protocols and Reports to support  validation execution of Equipment and complete production lines  such as Packaging and Manufacturing lines, Critical systems and Facility systems.

Risk Assessment


  • Development of process mapping for new facilities   
  • FEMA for new equipment  
  • Execution of component impact assessments for critical equipment and/or systems   
  • Conduct Supplier and Vendor assessments   
  • Support and perform decommissioning assessments.
  • Development and Writing of protocols to support IQ/OQ/PQ  

Execution

Our team has executed many projects successfully for different industries on multiple levels of support.

We can be on site full time and execute fully and independently or we can execute portions of the project at your choice.

Support

Our team is here for you when ever and where ever  you need it.

Only documentation, only execution, consultation or full blown project execution will be your choice.

We will deliver on time and at unbeatable prices.

Specialization

     

  • Steam autoclave sterilizers
  • Refrigerators and Warehouse Temperature 
  • Incubators and temperature controlled rooms 
  • Serialized Packaging Lines 
  • Depyrogenation Tunnels & Ovens
  • Vial washing machines
  • Compounding systems and vessels
  • Active PTC 
  • PFS and Vials filling machines
  • Isolators
  • Qualification of PSS (Purified Steam System) 
  • Laboratory Equipment