Equipment Qualification

Evidence your equipment is suitable for its intended use

Equipment Qualification is the documentation that your equipment is installed correctly and functioning per specification.   Equipment qualification tests the characteristics and functions of the system, not the output (product) produced by the system.  Falling within the scope of Validation, completion of this step ensures that your equipment is ready to test as part of a process in conjunction with other systems (process performance qualification).  

Services

  • Validation Project Management
  • Validation Plan Development and Execution
  • Change Control Documentation
  • System Assessment (GxP)
  • Risk Assessment & Mitigation
  • User Requirements (URS) Development
  • Design Specification Documentation (compilation of vendor documents)
  • Maintenance Plan Implimentation
  • Validation Issue Resolution 
  • Design Review
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Requirements Traceability (RTM)
  • Validation Report Development
  • System SOP Development
  • System Training 

Equipment Examples

Equipment is considered to be single skid or smaller COTS equipment.

  • Mixers
  • Blenders
  • Coaters
  • Fluid Bed Driers
  • Tablet Presses
  • Tablet printer
  • Encapsulor
  • Scale

 

  • Bottle cleaner
  • Filler
  • capper
  • enduction sealer
  • check weigher
  • labeler (Serialized or Non-serialized)
  • Cartoner
  • Blister Thermoformer
  • Case packer (Serialized or Non-serialized)
  • Palletizer (Serialized or Non-serialized)

 

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CUSTOMER COMMENTS

Customer comments

 “Sequence has been, withoua shadow of a doubt, the most customer-centered company with whom I have ever had the pleasure to work.”  – Director, LinkedIn

“Compliance and Data is critical to our business.  Sequence understands that the right data management solution must fit our business needs as well as our compliance strategy.” – Sr. Manager, LinkedIn

 Sequence took our vision and with the most amazing teamwork strategies I have ever witnessed turned it into a viable reality.” – Sr. Manager, LinkedIn

“Thank you for the amazing efforts of your most innovative and hardworking staff.” – VP, LinkedIn

How Can We Help You?

855.844.7171 info@sequenceqcs.com

Global Headquarters:
  2100 Gateway Centre Blvd
  Suite 301
  Morrisville, NC 27560

Compliance Center:
  [Mailing Address]
  2500 Gateway Centre Blvd Suite 850
  Morrisville, NC 27560