Medical Devices: Accurate Consultants can prepare and implement the entire system or a specific subsystems to meet the FDA QSR compliance (21 CFR 820: Quality System Regulation/ Good Manufacturing Practices). There are five key elements to a quality system: Quality Manual, Quality procedures, work instructions, product quality plans, and production level quality records. Accurate Consultants can supply you with a FDA compliant quality manual and procedures that can be customized and implemented for your operation.

Our quality system program focus on the interrelationships between the seven major subsystems:

1) Management Controls
2) Design Control
3) Corrective and preventive action (CAPA)
4) Production and Process Controls
5) Records/Documents/Change Control
6) Material Controls
7) Facility and Equipment Controls

Pharmaceuticals: On August 21, 2002, FDA initiated a new approach to the regulation of drug product quality with a science and risk based approached, incorporating an integrated quality system approach.

Accurate Consultants can assess, prepare and implement the entire system or modify a specific subsystem, which focuses on the FDA’s System Based Inspection of Drugs in Compliance Program 7356.02.

Our quality system implementation program focus on the client’s organization and interrelationships between the six major subsystems:

1) Quality System
2) Facilities and Equipment
3) Materials System
4) Production System
5) Production and Labeling System
6) Laboratory Control System

Contact us today to discuss your Quality System needs
and for a non-obligatory consultation and quote.