Using Management Software For Your Quality System
The pharmaceutical industry can be tough, and finding a quality system model that will conform simultaneously conform to the FDA?s cGMP initiative, the ISO 9000 standards, 21 CFR Parts 210 and 211 regulation, and the FDA?s Critical Path Initiative can be even harder. And that is before you have to start dealing with 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.
The FDA?s approach to quality system models requires that senior managers are committed to developing and maintaining their quality systems. It takes time and dedication, and it doesn?t matter how much they may know about the complexities of a range of different quality system models, they will have to commit to working with their own quality system.
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.
Sometimes it can be a bit difficult to get the quality system in line with the other processes in the other departments. Many companies simply have a tendency to be disjointed and subjective. If you can automate those processes, though, it will be much easier to get all the quality, compliance, and procedural requirements to connect.
In the pharmaceutical industry, it sometimes seems that the facets of managerial responsibilities are innumerable. However, modern quality management solutions (GxP management solutions for instance) have been designed to consolidate and considerably ease the efforts required by pharmaceuticals management personnel.
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By N2H
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