Using Management Software For Your Quality System

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.

That?s why the FDA created an example of a quality systems model in the Quality Systems Approach to Pharmaceutical cGMP Regulations. This document will help pharmaceutical companies implement an efficient system that will help them meet those regulations. A major component of this document is the management responsibilities, and here we will discuss that component and the possibility to automate any associated tasks.

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.

The management should be responsible for the various aspects of quality maintenance and taking control of the data analysis and the decision making issues that are related to it. Unfortunately, many managers get bogged down in these early stages of the quality system, which can be very tedious and repetitive. And most of those stages are the ones that are easiest to automate.

Quality management personnel in regulated pharmaceutical environments can take advantage of “automation benefits” by using software solutions. In short, these solutions should provide the data and trending technology that makes it easy to identify quality system deviations and nonconformance events. With effective automation technology, important responsibilities of quality system maintenance are still managed but tedious administrative can be automated.

Another managerial responsibility is to make certain that the quality system plans line up with the manufacturer?s strategic plans. It doesn?t matter what kind of quality system you have, it is never a stand-alone system. It will have an effect on everyone in the company. That?s why it?s important that a pharmaceutical company?s plans meet with the simple requirements of the other systems and processes throughout the industry.

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.