A Recommended Quality System Model With Management Software
There are a lot of challenges in the pharmaceutical industry, and it can be especially difficult to find a quality system model that will simultaneously conform to the FDA?s cGMP initiative, 21 CFR Parts 210 and 211 regulations, ISO 9000 standards, the FDA?s Critical Path Initiative, and any requirements from foreign regulatory bodies.
To help alleviate this problem, the FDA created an example of a quality systems model in a document called the Quality Systems Approach to Pharmaceutical cGMP Regulations. This document can help companies implement a system to help meet those regulations. One of the major components covered here is the management responsibilities, and we will discuss that as well as the automation possibilities associated with it.
According to the FDA?s approach to a quality system model, senior management should always be committed to developing and maintaining the quality systems. This will take time and dedication. It doesn?t matter how much a manager may know about the details and the complexities of the different quality system models, he or she needs to commit to developing the quality system itself.
Management should be responsible (to reasonable degree) in all aspects of quality system maintenance and will often be in charge of data analysis and subsequent decision making issues. However, managers often spend most of their energy on the early stages of the quality system which are usually nothing more than tedious administrative tasks. This is unfortunate since many of the stages of quality system maintenance are prime opportunities for automation.
The regulated pharmaceutical environment has a lot of opportunities for management personnel to take advantage of the automation provided by these software solutions. Most of these solutions are packed with the most recent data and technological trends so they are ready to identify any quality system problems. By automating your tasks, but keeping the important ones in the hands of the management, you can eliminate many tedious and administrative chores.
One other managerial responsibility is to ensure that the quality systems line up with the manufacturers strategic plans. It doesn?t matter what kind of quality system you are dealing with, you have to understand that it is not a stand-alone system. Every in the company is affected by it. That?s why it is critical to line up your plans with the requirements and systems already existing throughout the company.
It can be difficult, however, to align quality system management with other processes and departments (even beyond manufacturing) because departments have a natural tendency to be disjointed and subjective. An automated process will allow pharmaceutical companies to essentially connect quality, compliance and everyday procedural processes with applications that are launched from one platform.
It can be difficult to deal with all the managerial responsibilities in the pharmaceutical industry, but a modern quality management solution can make it a lot easier. Now you consolidate your tasks and reduce the required effort by implementing an automated system.