The GPMG modular quality system was originally developed to expedite factory relocation projects and to rapidly address quality system gaps identified during FDA QSIT preparation audits. The modularized approach also gives GPMG the ability to support the quality systems needs of start-up manufacturers and distributors who are typically faced with resource and cost challenges.
Common applications of the modularized quality system are existing manufacturers with compliance gaps, new divisions or start-ups, distributors, brand only companies outsourcing manufacturing activities, contract design facilities, and contract service providers
Potential benefits of the system include:
• implementation can follow a logical sequence
• increased control over implementation process
• simplifies project management and tracking
• providing a rapid solution for a specific need
• adaptable to varying organizational structures
• reduced time to certification and compliance
• reduced resources and costs
Global Pacific Manufacturing Group llc is a privately held global consulting company that provides engineering and manufacturing consulting services to the medical device industry.