Development of Quality Management Systems

                         

Four Generations of Quality Management Systems (QMS) :

1) Paper-based processes, or in electronic forms and word processing tools

2) Database environments

3) point solutions (individual quality process)

4) Single Platform


Problems in 4th Generation of QMS :

• The need to manage the training records and documents related to quality processes as part of a quality process
• Proliferation of uncorrelated data repository systems within the organization (e.g. multiple complaint systems, supplier CAPAs, etc., requiring manual effort for closed loop processes
• Insufficient focus on connecting business and quality management directly into core quality processes.

What needs to change ?

The next generation of software-based quality management systems must address fundamental requirements to integrate :-

• Forms - based processes
• Quality documents
• Unstructured collaboration (e.g. emails)

Reason :  Data burden - doubling within 15 months


Summary :

Future QMS solutions enable companies to gain deep and meaningful improvements in quality and not just address regulatory compliance.

Source :  amehta@nextdocs.com