A Quality System for Medical Device Companies Doesn’t Have to Rely on Paper
Great opportunities await those medical device companies that get comfortable with electronically based quality systems.
According to a white paper entitled Visibility & Control Minimize Risk: MES for Growing Medical Devices Companies1 (published in conjunction with industrydirections.com), "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 medical devices companies have in common is that they are growing."
Good News for Medical Device Companies
If medical device companies are growing, it stands to reason that their respective quality related processes will naturally expand and dilate as well, leaving many 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 Quality System
Some medical device companies are falling behind and one reason for the lag is quite evident. These companies are implementing quality systems that include paper-based or hybrid document control processes. Of course, even with these paper-based/hybrid document control processes, medical device companies may produce the amount of products they wish to produce, but the questions for medical device producers are the following:
• How much revenue will your company spend on tedious man hours that are used to route, obtain approval and locate elusive document versions?
• 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?
• How many document versions has your company edited only to realize the latest document version wasn’t really the latest?
• How many outdated SOPs have been adhered to with inevitable (and uncomfortable) product recalls?
• In other words, how expensive is it to maintain loyalty to paper?
Leave a Quality System 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 medical devices companies 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 a Quality System with Electronically Based Documentation Management
On the other hand however, using an electronic quality system (web-based is preferred) with electronically based documentation control is likely your best option for a sure 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 system with no operator intervention. Those who automate more will increase throughput and reduce compliance risk."
Another Support for an Electronic Quality System
Another element of the regulated medical device environment is that of change management and CAPA (Corrective and Preventative Action) procedures. These elements are essential to the success of quality system that will result in mass produced medical 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 quality system is also the preferred method of quality system management.
Imagine the branch of a quality system that would actually manage change management and CAPA forms electronically and trigger results automatically! The issue after all, would be far more applicable to 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 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.
1 To access this article visit FDAnews.com, click on "white papers" and select the Visibility & Control Minimize Risk: MES for Growing Medical Devices white paper.
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regards to quality system software solutions, please feel free to
In addition, the white paper also states that "What most medical devices companies have in common is that they are growing."
Good News for Medical Device Companies
If medical device companies are growing, it stands to reason that their respective quality related processes will naturally expand and dilate as well, leaving many 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 Quality System
Some medical device companies are falling behind and one reason for the lag is quite evident. These companies are implementing quality systems that include paper-based or hybrid document control processes. Of course, even with these paper-based/hybrid document control processes, medical device companies may produce the amount of products they wish to produce, but the questions for medical device producers are the following:
• How much revenue will your company spend on tedious man hours that are used to route, obtain approval and locate elusive document versions?
• 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?
• How many document versions has your company edited only to realize the latest document version wasn’t really the latest?
• How many outdated SOPs have been adhered to with inevitable (and uncomfortable) product recalls?
• In other words, how expensive is it to maintain loyalty to paper?
Leave a Quality System 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 medical devices companies 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 a Quality System with Electronically Based Documentation Management
On the other hand however, using an electronic quality system (web-based is preferred) with electronically based documentation control is likely your best option for a sure 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 system with no operator intervention. Those who automate more will increase throughput and reduce compliance risk."
Another Support for an Electronic Quality System
Another element of the regulated medical device environment is that of change management and CAPA (Corrective and Preventative Action) procedures. These elements are essential to the success of quality system that will result in mass produced medical 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 quality system is also the preferred method of quality system management.
Imagine the branch of a quality system that would actually manage change management and CAPA forms electronically and trigger results automatically! The issue after all, would be far more applicable to 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 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.
1 To access this article visit FDAnews.com, click on "white papers" and select the Visibility & Control Minimize Risk: MES for Growing Medical Devices white paper.
Marci Crane is a copywriter for MasterControl in Salt Lake City, Utah. For more information in regards to quality system software solutions, please feel free to
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By Marci Crane Published: 12/14/2007 |
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