QSI Consulting

 

Founded by Shaun McCormack in 2001, we specialize in providing practical and cost-effective solutions to design, document, and validate your facility,

utility systems, computerized systems, software, and equipment in a CGMP

compliant state while maintaining and improving FDA and/or European (ISO)

regulatory compliance.

 

We focus on working collaboratively with our clients to bring them

Validation and Quality Services so they are Compliant and Productive.

 

Our Team:

     • 17 continuous years providing Validation and Quality consulting

     • Technically Proficient - over 90% of field Consultants with

       Engineering and/or Science Degrees

     • Entire staff experienced in working in a Regulated Environment

     • Flexible: Can support your Quality and Validation teams as added

        resources or can build you programs and processes that define

        your validation goals and compliance strategy

        - see our body of work (project abstracts)

QSI Testing & Certification

 

Our Team:

     • NSF Accredited Technicians combine 31 years of industry

        experience

     • Responsive - Can deploy resources on short notice,

        (if required)

     • Timely and Accurate Reporting; a critical component

        of our approach