A high quality Technique For Health care Machine Companies Does not have to Rely on Paper

Based on a white paper entitled Visibility & Control Minimize Risk: MES for Growing Healthcare Devices Companies1 (published in conjunction with the industrydirections website), "Many medical devices manufacturers are having difficulty keeping up with the growing demand for the products they make."

In addition, the white paper also states that "What most professional medical devices providers have in common is that they are growing."

Good News for Clinical System Corporations

If medical unit businesses are blood sample, it stands to reason that their respective top quality related processes will naturally expand and dilate as well, leaving many top quality processes and departments disjointed and broken (i.e. growing pains) without the necessary functionalities. After all, increased demands require increased speed, efficiency and accuracy, and where is the speed, efficiency and accuracy to be derived but from better technology?

Keeping Up with Opportunity: Using an Electronic Excellent Procedure

Some healthcare gadget businesses are falling behind and one reason for the lag is quite evident. These businesses are implementing top quality systems that include paper-based or hybrid document control processes. Of course, even with these paper-based/hybrid document control processes, health-related gadget organizations may produce the amount of products they wish to produce, but the questions for health care gadget producers are the following:

o How much revenue will your company spend on tedious man hours that are used to route, obtain approval and locate elusive document versions? o How many quality or compliance related documents does your company lose on a regular basis? How much revenue is lost due to these costs on an annual basis?

o How many document versions has your company edited only to realize the latest document version wasn't really the latest?

o How many outdated SOPs have been adhered to with inevitable (and uncomfortable) product recalls?

o In other words, how expensive is it to maintain loyalty to paper?

Leave a high quality Method with Paper Based Documentation Management Behind Forever

The article mentioned above (Visibility & Control Minimize Risk: MES for Growing Medical Devices) also says the following, "Most health-related devices corporations key most of the data they need for metrics into spreadsheets. This introduces time lags, errors, and non-value added data entry time for operations employees." (to see a graph related to this text, please refer to the article itself).

See the Benefits of an outstanding Method with Electronically Based Documentation Management

On the other hand however, using an electronic high-quality system (web-based is preferred) with electronically based documentation control is likely your best option for a sure high quality foundation. For example, the same article states that, "While signatures for compliance require operator entry and therefore can only be partially automated, some of the data for metrics can be fully automated, in other words, entered into the technique with no operator intervention. Those who automate more will increase throughput and reduce compliance risk."

Another Support for an Electronic Quality Program

Another element of the regulated clinical device environment is that of change management and CAPA (Corrective and Preventative Action) procedures. These elements are essential to the success of excellent program that will result in mass produced clinical devices. However, if that information for change or investigation is not disseminated as quickly as possible the information itself becomes increasingly LESS valuable. For that reason, an electronic high-quality procedure is also the preferred method of quality technique management.

Imagine the branch of a quality process that would actually manage change management and CAPA forms electronically and trigger results automatically! The issue after all, would be far more applicable into a change control manager after the lapse of an hour vs. the lulling gap of 3 weeks.

Conclusion

An automated, electronic quality system has become a necessity for those professional medical device companies that want to produce products more quickly, receive less customer complaints, avoid large amounts of product recalls and get their products on the market (and into the hands of consumers) with less delay.