Automation System Qualification

Evidence your Automation System is suitable for its intended use

Automation Qualification documents that your automated system is installed correctly and functioning per specification.   Automation 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 system is ready to tested as part of a process in conjunction with other systems (process performance qualification).


  • 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 

Automation System Examples

Automated Equipment is considered to be highly configurable or bespoke systems.

  • CIP Systems
  • Product transfer Systems
  • Process Automation Systems
  • Equipment with custom sequential logic


  • Distributed Control Systems
  • Building Automation Systems
  • Building Management Systems
  • Purified Water Systems
  • Utility Control Systems




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?


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

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