Visual Sample Tracking and Management Software Visual Sample Tracking and Management Software
21 CFR Part 11

Title 21 CFR Part 11 of the Code of Federal Regulations deals with the FDA guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.

The current Good Manufacturing Practices (GMP) requirements set forth in the Quality System (QS) regulation require that domestic (US) or foreign manufacturers have a quality system for the design and production of medical devices intended for commercial distribution in the United States.

 
The regulation requires:

Specifications and controls be established
Devices be designed under a quality system
Finished devices meet these specifications
Devices be correctly installed, checked & serviced
Data be analyzed to identify and correct problems
Complaints be processed
 
The QS regulation helps assure that medical devices are safe and effective for their intended use.
 
Our validation specialists can carry out full or partial audits, internal or second or third party audits by a fully trained expert in the QSR.