Who We Help

Client: Undisclosed, Milford, MA

• Project Role: Lead the commissioning and validation of all equipment and systems (utilities, production equipment, software) during the design and

   construction expansion of a 10,000 sq. ft. DNA and RNA manufacturing facility

• Two Phase Project occurring simultaneously: Manage concurrent processes throughout the 18 month engagement

• Complete life cycle of validation and commissioning processes from Equipment Design, Electronic software assessment, FAT/SAT, Commissioning, and IQ/OQ/PQ

• Equipment and Computerized Systems validated include: USP Water, HVAC, Chromatography Columns, Process Control Systems, Synthesis Tanks, Freeze Dryer,

   Ultrafiltration Skids

• Work collaboratively with Facilities, Engineering, Manufacturing, and Quality to develop a Validation Project Plan

• Execute the Validation Project Plan during a aggressive facility design/build project

Client: Undisclosed, Bedford, MA

• Project Role: Nine year relationship with a global medical technology company at the forefront of orthopedic pain management

• Various Quality and Validation functions including interim role as Director of Quality

• Currently leading the validation and commissioning effort during the design and construction of a new manufacturing facility and subsequent move of

   manufacturing equipment and processes from Europe.

• Creating 500 plus documents to support 30-40 processes and 80 new or relocated pieces of equipment

• Client: Undisclosed, Lexington, MA

• Role: Multi-year Quality and Validation engagement

• Support of equipment and facilities through clinical trial of an innovative treatment in the orthopedic space

• Develop and execute protocols (IQ,OQ,PQ) for new production space in Lexington, MA

• Generation of Standard Operating Procedures for Manufacturing and Quality Control equipment.

• Client:

• Four year relationship

• Responsible for the companies complete validation/revalidation program as well as cleanroom cleaning services

• Client:

• SIx year relationship

• Responsible for the companies complete validation/revalidation program

• Client:

• Provide Document Control and Quality resources

• QSI CEO was interim Quality Director