| Medical device companies manage their respective | | | | communication suddenly engenders results---not |
| quality systems not with the goal of “staying | | | | illusions. |
| busy” but with the ideal of producing | | | | #4: Uniting Quality Systems Across Geographic |
| high-quality, innovative products that don’t | | | | Barriers |
| jettison a trail of product recalls and process | | | | When a medical device company begins to |
| deviations along the way. Every medical device | | | | expand or continues to do so, automated |
| designer, manufacturer or quality control | | | | software that is web-based becomes the pot of |
| representative would likely agree that medical | | | | gold at the end of the rainbow. Web-based |
| device companies should standardize a process | | | | solutions for instance allow companies to expand |
| that gives birth to high quality products and | | | | on a national or global level and still stay abreast |
| simultaneously attacks every deviation, | | | | of salient information. Medical device companies |
| nonconformance or customer complaint with the | | | | (depending on their current situations) are also |
| speed and vigor of Spartan warriors. | | | | likely to benefit from a software provider that |
| Simple enough? | | | | allows medical device companies to select from |
| It would seem so but even with all the combined | | | | various networking options (shared licences, EFP |
| brain talent of designers, manufacturers and | | | | replication, etc.). |
| quality control personnel this ideal bionic process | | | | #5: Help Make Quality an Aspect of Every |
| still seems like nothing more than a medical device | | | | Department |
| nirvana. In fact, current quality system | | | | For many medical device companies, quality |
| management habits within most medical device | | | | system management is in the hands of the quality |
| companies emulate Isaac Newton’s first law | | | | control team. Although this establishment of |
| by remaining “in a state of uniform | | | | responsibility has worked in the past, quality |
| motion…unless an external force is | | | | system management now must move faster and |
| applied…”1 | | | | more efficiently to meet increased demands for |
| The External Force for Medical Device Quality | | | | quality products. The truth is that much of a |
| Systems | | | | quality system can be managed bit by bit and |
| The external force that should be applied to most | | | | employee by employee when training is |
| medical device quality systems is the force that is | | | | automated and a quality management system |
| inevitably required by almost every industry. That | | | | (plus associated information) is available quickly for |
| force is technology. The right technology can help | | | | the right employees in the right departments. |
| medical device companies create the streamlined | | | | Medical device companies also need to search for |
| and automated quality system processes that | | | | a training software solution that can be |
| WON’T vary under any circumstances unless | | | | automatically triggered by essential document |
| confirmed and logical data points to | | | | changes and that can control GLP, GCP and GMP |
| evidence-based deviations, nonconformances, | | | | training tasks (plus other training tasks) across a |
| customer complaints, etc. | | | | company wide spectrum. |
| That’s one reason for medical device | | | | Curt Porritt, VP of Marketing at MasterControl |
| companies to start automating their quality | | | | says the following in his article entitled Adopting |
| systems with the right quality system | | | | Technology in the Life Science Industry: Why Is It |
| management technology. Listed below are 4 | | | | Taking So Long? states and paraphrases the |
| more: | | | | following: |
| #2: The FDA is Moving along the Automation | | | | “…according to Life Science Insights, an IDC |
| Pathway | | | | company, over 60% of survey respondents cited |
| Let’s face it. The FDA rules the U.S. | | | | GMP/GCP/GLP processes as the main driver for |
| regulatory roost and every medical device | | | | increased IT spending. In this same survey, 62% |
| company that wants to produce or sell products | | | | of respondents said they intended to spend more |
| in the U.S. has to conform to its quality system | | | | on electronic data integration tools. When asked |
| regulations. Conforming with FDA regulations | | | | why they intended to spend more, their main |
| becomes easier when FDA requirements are duly | | | | reasons (in the order cited) were: increased |
| anticipated by medical device companies. For | | | | collaboration, regulatory compliance requirements, |
| example, a recent FDA News bulletin states that, | | | | reduced time for one or more processes, and |
| “FDA-mandated electronic Medical Device | | | | reduced costs for one or more processes.”5 |
| Reporting (eMDR) could happen in a soon as 18 | | | | Conclusion |
| months,” which means that medical device | | | | Mary Collins, director of regulatory and industry |
| submissions will soon have to be submitted | | | | relations for |
| electronically and medical device submissions are | | | | Image Solutions Inc. says the following in regards |
| far easier to submit electronically when they are | | | | to the implementation of electronic software |
| consistently managed electronically with an | | | | solutions: |
| automated quality system solution. | | | | “No matter how you get started |
| #3: Decrease Quality System Breakdowns | | | | [implementing electronic solutions], you [must] get |
| George Bernard Shaw once said that “The | | | | started now. Over the next 10 years, you will see |
| problem with communication ... is the illusion that it | | | | the different regions of the world come closer |
| has been accomplished.”3 The illusion that | | | | together and harmonize more on electronic |
| information is being communicated or that | | | | requirements, and, to some extent, their |
| employee morale is “fine” is often the sign | | | | regulatory requirements.” 4 |
| of communication breakdown. Communication | | | | For medical device companies, the advice remains |
| breakdowns are catalyzed by tedious paper-based | | | | the same. Staying connected with quality system |
| routing procedures, capsulated quality processes | | | | technology will help med device companies keep |
| that disconnect product lifecycles, customer | | | | pace with changing quality system standards. |
| complaints that never reach the investigations | | | | _______ |
| department, approvals that are too numerous to | | | | References |
| complete quickly, possible deviations that | | | | 1 csep10.phys.utk.edu/astr161/lect/history |
| can’t be backed with proof, etc., etc. | | | | newton3laws.html (Retrieved Jan. 24, 2008) |
| Once medical device companies automate | | | | 2 FDA News email (Received Jan. 24, 2008) |
| document control, information routing, approvals, | | | | 3 wisdomquotes.com/cat_communication.html |
| quality data connections (customer complaints to | | | | (Retrieved Jan. 24, 2008) |
| CAPA investigations, etc.) and provide tracking | | | | 4 mastercontrol.com/newsletter/feature |
| and reporting features that help readily identify | | | | adopting_technology_1007.html (Retrieved Jan. |
| deviations and nonconformances, REAL | | | | |