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Coherent Speed is Clarkston’s methodology for accelerating the solution definition and delivery processes for our clients.

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Quality Management
Tools

Clarkston’s Quality Systems expertise includes:

  • A variety of enabling technologies.
  • Consultants with extensive experience in the pharmaceutical, biotech, and medical device industries.
    • Global initiatives in nine countries and multiple languages
    • Our clients rank Quality Systems as the highest among Clarkston’s services
  • Repeat and referral work accounts for 90% of our business
    • Full-suite of services across multiple quality system areas
    • Proven Quality Systems Methodology with unique accelerators
    • Service Specific Methodologies within Coherent Speed have been created with tools, templates, and accelerators for Quality Systems, Process, and Computer Systems Validation
  • Accelerator Kits: Templates, Flows, SOPs, Testing, and Training Materials that can be tailored to meet your needs.

 

Quality Systems

Quality systems solutions expertise includes:

  • SAP
  • LabWare LIMS
  • VelQuest LES
  • TrackWise QMS
  • Sample Manager LIMS
  • Agilent OpenLAB
  • OpenText, GxPharma
  • TraceLink
  • Documentum

 

Quality Management Services expertise includes:

  • EDMS (electronic data management systems)
    • Project Management
    • Business Process/SOP
    • Technical Workflow Configuration
    • Validation
    • Training/Change Management
    • Systems Integration
  • MES (Manufacturing Execution Systems)
    • Project Management
    • Business Process/SOP
    • Technical Workflow Configuration
    • Validation
    • Training/Change Management
    • Systems Integration
  • LIMS (Laboratory Information Management Systems)
    • Vendor Selection /Business Case
    • Project Management
    • Process/SOP
    • Technical Workflow Configuration
    • Validation
    • Training/Change Management
    • Systems Integration
  • QMS (Quality Systems Management)
    • Vendor Selection /Business Case
    • Project Management
    • Process/SOP
    • Workflow Configuration
    • Validation
    • Training/Change Management
    • Systems Integration