About Quality Promise

Quality Promise, LLC is an outsourced service for Quality Management Systems (QMS) such as: Customer Complaints, Review of Supplier Investigations, Documentation and Change Control, Training, and Pre / Post Batch Record Review. In addition, provide intake and triage service for Customer Complaints (remote call center needs) and GMP/GDP documentation.

Quality Promise serves the Pharmaceutical, Medical Device, IVD, Biotech and Clinical industries within the United States (USA).

Quality Management by Experts

As quoted by Steve Jobs “THE ONLY WAY TO DO GREAT WORK IS TO LOVE WHAT YOU DO”. With over twenty years within the Medical and Pharmaceutical industry and working with companies that have had great Quality Management Systems to companies where no Quality Management System were in place has helped build the knowledge and the passion for assisting companies to become compliant with industry standards.

Guidance to the manufacture to demonstrate not only the quality of a finished product, but also the consistency of manufacturing processes involved in its production and verify claims for the effectiveness of a product. In addition, a couple of QSR violations cited in 483s and warning letters that get all the attention: CAPA, design control, process validation and complaint files.

Document Controls
Maintenance of Device Master Records (DMR)
Pre / Post Device History Records (DHR)
Monitor & Maintain Calibration Schedules and Records
Maintenance of Design History Files
Production Process Control

Purchasing Controls
Receiving , In-process and Acceptance
Complaints
Internal / External Audits
Nonconforming Product
Corrective and Preventive Action (CAPA)