At Sequence Inc., our Manufacturing Systems team is focused on providing our clients with best in industry facility, utility, equipment, and automation qualification services.  We have experience in traditional qualification methodologies as well as ASTM E2500 risk-based qualification approaches. Our consultants pride themselves on providing industry-leading qualification.  What makes Sequence Inc. succeed? We develop meaningful client relationships with onsite engineering, manufacturing, and quality assurance personnel. This approach allows our clients to trust our work and trust their most important projects to Sequence.

Sequence has extensive experience in developing qualification plans, protocols, and strategies to meet both regulatory requirements and client standards.  Our consultants have performed over 550,000 combined service hours on controls platforms, equipment, facilities, and utility qualifications. They have also developed risk-based verification methods to mitigate cost and schedule impact for the largest capital projects in the life sciences industry.  

Our experience includes:

  • Gap assessment of existing equipment/facilities against current regulatory requirements.
  • Validation and quality program development for all phases of manufacturing (for additional information see **link to quality programs & compliance**
  • Development and execution of protocols for various automated manufacturing systems to include DCS, MES, SCADA, PLC, and HMI.
  • Development and execution of protocols for various equipment types including process skids, vessels/tanks, filling lines, assembly and packaging lines.
  • Process and cleaning validation including aseptic media qualification, recovery studies, and hold time studies.
  • Room classification design services and performance of clean room validation.
  • CQV services for dirty and clean utilities, including tie-ins between existing and new systems.