5 Reasons Medical Device Companies Should Automate Their Quality Systems

Medical device companies manage their respective quality systems not with the goal of “staying busy” but with the ideal of producing high-quality, innovative products that don’t jettison a trail of product recalls and process deviations along the way. Every medical device designer, manufacturer or quality control representative would likely agree that medical device companies should standardize a process that gives birth to high quality products and simultaneously attacks every deviation, nonconformance or customer complaint with the speed and vigor of Spartan warriors.

Simple enough?

It would seem so but even with all the combined brain talent of designers, manufacturers and quality control personnel this ideal bionic process still seems like nothing more than a medical device nirvana. In fact, current quality system management habits within most medical device companies emulate Isaac Newton’s first law by remaining “in a state of uniform motion…unless an external force is applied…”1

The External Force for Medical Device Quality Systems
The external force that should be applied to most medical device quality systems is the force that is inevitably required by almost every industry. That force is technology. The right technology can help medical device companies create the streamlined and automated quality system processes that WON’T vary under any circumstances unless confirmed and logical data points to evidence-based deviations, nonconformances, customer complaints, etc.

That’s one reason for medical device companies to start automating their quality systems with the right quality system management technology. Listed below are 4 more:

#2: The FDA is Moving along the Automation Pathway
Let’s face it. The FDA rules the U.S. regulatory roost and every medical device company that wants to produce or sell products in the U.S. has to conform to its quality system regulations. Conforming with FDA regulations becomes easier when FDA requirements are duly anticipated by medical device companies. For example, a recent FDA News bulletin states that, “FDA-mandated electronic Medical Device Reporting (eMDR) could happen in a soon as 18 months,” which means that medical device submissions will soon have to be submitted electronically and medical device submissions are far easier to submit electronically when they are consistently managed electronically with an automated quality system solution.

#3: Decrease Quality System Breakdowns
George Bernard Shaw once said that “The problem with communication ... is the illusion that it has been accomplished.”3 The illusion that information is being communicated or that employee morale is “fine” is often the sign of communication breakdown. Communication breakdowns are catalyzed by tedious paper-based routing procedures, capsulated quality processes that disconnect product lifecycles, customer complaints that never reach the investigations department, approvals that are too numerous to complete quickly, possible deviations that can’t be backed with proof, etc., etc.

Once medical device companies automate document control, information routing, approvals, quality data connections (customer complaints to CAPA investigations, etc.) and provide tracking and reporting features that help readily identify deviations and nonconformances, REAL communication suddenly engenders results---not illusions.

#4: Uniting Quality Systems Across Geographic Barriers
When a medical device company begins to expand or continues to do so, automated software that is web-based becomes the pot of gold at the end of the rainbow. Web-based solutions for instance allow companies to expand on a national or global level and still stay abreast of salient information. Medical device companies (depending on their current situations) are also likely to benefit from a software provider that allows medical device companies to select from various networking options (shared licences, EFP replication, etc.).

#5: Help Make Quality an Aspect of Every Department
For many medical device companies, quality system management is in the hands of the quality control team. Although this establishment of responsibility has worked in the past, quality system management now must move faster and more efficiently to meet increased demands for quality products. The truth is that much of a quality system can be managed bit by bit and employee by employee when training is automated and a quality management system (plus associated information) is available quickly for the right employees in the right departments.

Medical device companies also need to search for a training software solution that can be automatically triggered by essential document changes and that can control GLP, GCP and GMP training tasks (plus other training tasks) across a company wide spectrum.
Curt Porritt, VP of Marketing at MasterControl says the following in his article entitled Adopting Technology in the Life Science Industry: Why Is It Taking So Long? states and paraphrases the following:
“…according to Life Science Insights, an IDC company, over 60% of survey respondents cited GMP/GCP/GLP processes as the main driver for increased IT spending. In this same survey, 62% of respondents said they intended to spend more on electronic data integration tools. When asked why they intended to spend more, their main reasons (in the order cited) were: increased collaboration, regulatory compliance requirements, reduced time for one or more processes, and reduced costs for one or more processes.”5
Conclusion
Mary Collins, director of regulatory and industry relations for
Image Solutions Inc. says the following in regards to the implementation of electronic software solutions:
“No matter how you get started [implementing electronic solutions], you [must] get started now. Over the next 10 years, you will see the different regions of the world come closer together and harmonize more on electronic requirements, and, to some extent, their regulatory requirements.” 4
For medical device companies, the advice remains the same. Staying connected with quality system technology will help med device companies keep pace with changing quality system standards.
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References
1 csep10.phys.utk.edu/astr161/lect/history/newton3laws.html (Retrieved Jan. 24, 2008)
2 FDA News email (Received Jan. 24, 2008)
3 wisdomquotes.com/cat_communication.html (Retrieved Jan. 24, 2008)
4 mastercontrol.com/newsletter/feature/adopting_technology_1007.html (Retrieved Jan. 24, 2008)
5 http://209.85.173.104/search?q=cache:4Vn3H0TV2O0J:www.parexel.com/pdfs/e-solutions%2520in%2520clinical%2520trials%2520-%2520R%26D%2520Directions%25207.07.pdf+E-Solutions+in+Clinical+Trials:+Digital+Dilemma+Michael+D.+Christel+pharmalive.com&hl=en&ct=clnk&cd=1&gl=us (Retrieved Jan. 24, 2008)