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Quality Management System Considerations

There are several things to consider before developing / implementing an electronic quality system. The ideal of an electronic quality system is to be able to gather, store and retrieve data in a consistent and integral manner. The following seven concepts should be kept in mind when developing your electronic quality system.

  1. Simple, straight forward workflows are the best approach. Creating a system that is too complex will only disengage people so that they are less likely to use the system. Taking into account all of the critical sign offs, mandatory information, and reports needed, your system is going to be complex enough. 

  2. Your electronic quality system should not always mimic your current, existing paper based system. Paper based systems are great in a paper based world, and trying to incorporate those systems into an electronic one will often lead to a high degree of customization, which will lead to a high degree of complexity and maintenance, and as captured in point number one (1) – Simplicity is the key. Taking the time to understand what functions you can get from your chosen electronic application will help greatly in achieving simplicity. 

  3. Most of the electronic quality system platforms available have evolved in such a way to make it easy and understandable for individuals to use. A fundamental reason is the simplicity of the system. There are, what I consider, three types of information that get entered into an electronic quality system: mandatory information, conditional information, and nice to have information. Mandatory information is just that, required information needed for the quality system record. Conditional information is needed based on the result of proceeding mandatory information. Nice to have information is not mandatory nor is conditional but is a benefit to the system’s efficiency, the company’s needs (i.e. metrics), trending, or tracking of records. 

  4. Regardless of what type of information that goes into your electronic quality system, an important aspect is how this information is entered into the system. Whenever possible, and to keep the data integral, selection fields with set values should be used. For example, if you have a building name/number as a piece of information to be entered, the system should be set up to have a drop down listing of all building names/numbers that are possible choices. Just to compare, another type of field is a free text field. This field type basically means that you can type whatever you want into these fields (i.e. typos, transcription errors, semantics and connotation). Bottom line- there is no content control and therefore no consistency to the data that goes into the free text fields. 

  5. Who can do what in an electronic quality system is an important aspect to consider before developing / implementing. This not only ensures that the correct person is performing the correct activity and at the correct time, it also is in line with being compliant with Part 11 of the code of federal regulations (CFRs). This can be accomplished by setting up permissions within the electronic quality system. These permissions will only allow specific people to perform specific tasks within the system. Determining this ahead of time would be beneficial. 

  6. Consider having the electronic quality system notify the appropriate people, groups, or departments at the appropriate times about the progression of the record through the workflow. These notifications will help to ensure that communication is maintained about who needs to perform what activities within the system and when. 

  7. Lastly, consider the use of reports created within and extracted out of your electronic quality system. All of the previous points made so far are on how to set up and input into your system. This last point is to make careful consideration on what you want out of the system, especially for presentation purposes to regulatory body agencies, and upper management. These reports can be as simple as the mandatory information from one record, or an entire system multi-record report for metrics or trending purposes. Regardless of what type of reports you want, they will be viewed as the focal point and represent your electronic quality system. 

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