Manufacturers turn to OneSource to create the IQ OQ PQ protocols and documents needed for their equipment and used by their customers.

OneSource develops qualification and validation protocols for:

• OEMs looking for a cost-effective way to create robust, audit-proven document instrument qualification standards for clients.
• IQ OQ PQ protocol development for legacy systems or new instruments.
• Specialized IQ OQ PQ protocols for unique, one of a kind instrumentation.

Examples of the qualification and validation protocols OneSource has created for instrument manufacturers

• ESPEC HAST Chamber
  HAST (Highly Accelerated Stress Test) Chambers are high temperature, humidity, and pressurized chambers used to reduce the time it takes to complete humidity testing.
  
  The complete IQ OQ PQ validation of the ESPEC EHS-221MD HAST Chamber was developed and performed by OneSource compliance experts for a pharmaceutical / medical device manufacturer to use in GLP/GMP environments.
• ESPEC Lab Series Environmental Chamber
  The LHU-113 Environmental Chamber is ESPEC’s compact bench-top environmental chamber, suitable for a wide variety of applications in the pharmaceutical, automotive, materials and electronic industries.
  
  The complete IQ OQ PQ validation of the ESPEC Model LHU-113 was developed and performed by OneSource compliance experts for pharmaceutical use in a GLP/GMP environment.
• Two PIAB Vacuum Conveyor Systems
  OneSource compliance experts undertook development of the qualification protocol and the successful IQ OQ PQ validation of two unique vacuum conveyor systems at PIAB USA.
  
  OneSource and PIAB USA technical staff collaborated to develop the IQ OQ PQ protocol for validation of the C21 and C33 Series Vacuum Conveyers. Upon approval of the protocols, the OQ PQ validation was performed under real-world conditions.
  
  The qualification protocols included the measurement and verification of pressure, vacuum, and sound using NIST traceable devices and the proper transfer of materials from feed station to final destination.

  How may I help you?

  Contact Joe Tehrani PhD, Global Regulatory Compliance Leader, to start development of the qualification and validation protocols that will ensure your customers have the documents needed to maintain their regulatory compliance status.

  Joe Tehrani, Ph.D.
  Global Business Leader
  Qualification & Relocation Solutions
  PerkinElmer OneSource Laboratory Services